chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a reaction in her arms at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Developed a reaction in her arms at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    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 VACCINATION SITE REACTION (Developed a reaction in her arms at the injection site). At the time of the report, VACCINATION SITE REACTION (Developed a reaction in her arms at the injection site) 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 relevant concomitant medications were reported. Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
immed itching & erythema @ site of inj onset of induration w/in 20mins;also c/o pain in lt elbow below site of inj;no SOB or wheezing-no hives;epi given;
Fever- over 102; Body aches; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13247), via an unspecified route of administration in the right arm on 05Feb2021 03:30 PM at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever- over 102, body aches, chills, nausea on 06Feb2021 at 02:00 PM. The patient was not pregnant at the time of vaccination. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient had covid test post vaccination via nasal swab with negative result. Outcome of the events was recovered.   No Follow-up attempts are needed. No further information is expected.
Blood sugar better controlled; Sore left injection site arm; Got the flu shortly after; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Blood sugar better controlled), INFLUENZA (Got the flu shortly after) and VACCINATION SITE PAIN (Sore left injection site arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D1A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included INSULIN DEGLUDEC (TRESIBA FLEXTOUCH) and INSULIN ASPART (NOVOLOG) for Type 2 diabetes mellitus, METFORMIN for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Blood sugar better controlled) and VACCINATION SITE PAIN (Sore left injection site arm). In August 2021, the patient experienced INFLUENZA (Got the flu shortly after). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Blood sugar better controlled), INFLUENZA (Got the flu shortly after) and VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Blood glucose: 160 (abnormal) blood sugar went down to 160. On an unknown date, Blood glucose: 250 to 300 (High) 250 to 300.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported. The reporter states that the patient received first dose of Moderna Covid-19 vaccine and patient noticed that blood sugar was dropped, and patient blood sugar was running between 250 to 300 after the first dose of vaccine patient blood sugar went down to 160 and reporter states that the Patient was struggled to manage type 2 diabetes and taking insulin shots, after first dose patient diabetes seemed easier to control and patient got flu shortly after couldn't really exercise much. patient taking Metformin and other medications .   This case was linked to MOD-2021-321336 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received.Concomitant medications were added, new event influenza  was added.
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 14:45 (Lot number: FF8841) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 25Oct2021 02:45, outcome "recovering", described as "Fever". Therapeutic measures were not taken as a result of pyrexia.  Additional information: Other vaccine on same date was administered to the patient. Patient was administered a Pfizer vaccine (lot number=1693) on 25Oct2021, in Left arm, dose 1. No other vaccine were administered in 4 weeks. Other medications were given in two weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Brain Swelling, off-balance, depersonalization, derealization, central nervous system abnormality reported by an ENT specialist, memory loss, difficulty concentrating, Hashimoto's thyroiditis (autoimmune hypothyroid).
Administred shots (TDap, Hep A). Pt syncope 2 times. Vitals taken 121/76 P-58 O2 99% - EMS called at 11:18 AM. Pt pale and diaphoretic. Dr called to scene.
Patient stated that she felt welt on arm about 24 hours after injection. Two days after pt. developed rash on arm. On the 4th and 5th day the patiet developed rash on neck and face and experienced pruritis.
Sunburn like feeling; Itching; hot to touch; Rash Spreading; Redness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of SUNBURN (Sunburn like feeling), PRURITUS (Itching), FEELING HOT (hot to touch), RASH (Rash Spreading) and VACCINATION SITE ERYTHEMA (Redness on injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SUNBURN (Sunburn like feeling), PRURITUS (Itching), FEELING HOT (hot to touch), RASH (Rash Spreading) and VACCINATION SITE ERYTHEMA (Redness on injection site). At the time of the report, SUNBURN (Sunburn like feeling), PRURITUS (Itching), FEELING HOT (hot to touch), RASH (Rash Spreading) and VACCINATION SITE ERYTHEMA (Redness on injection site) 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.  Treatment details included Lubricants on affected site.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
asthma attack; Arm hurt; This is a spontaneous report received from contactable pharmacist reporting for 3 patients. This is one of the 3 reports.  A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot Number: Unknown) as single dose for COVID-19 immunisation.  Medical history included severe asthma. Concomitant medications were not reported. The patient experienced asthma attack, arm hurt on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of asthma attack included a high dose of steroids and was off of them in 10 days.  No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: The association between the event asthma attack, with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient received Shingrix vaccine.  2-3 days later she developed a fever and a rash on her upper right thigh ankle and on left great toe. Reports this started 2 days after her shingles shot and has gotten worse. Reports fever fatigue and feeling really run down.  Reports that it is mildly uncomfortable and consistent with a chicken pox dx her children had.  Reports that she did have chicken pox as a child. Chicken pox- Keep area clean and dry, Tylenol for fever >100.3, Benadryl may help with the itch. Get plenty of rest Soothing lotion and moisturizers - Calamine solution can be applied on the rashes. Colloidal oatmeal also gives relief from itching. Patient advised to stay away from children and pregnant people.  Advised if sx worsen she should contact the office for further eval and treatment.
Had abnormal bloodwork and increased bruising. Large bruise noted on right lower leg medially. Bruise lasted 1 month Examined by Resident who  in conjunction with MD. ordered more blood work . Reviewed second blood work with MD and MD ordered ultrasound of liver and more blood work. Platelet count continues to decline and values for  AST and ALT  continue to rise.
Patient complained of fever for 3 days, rash around vaccinated area, redness, and soreness.
Patient was sitting down and said he felt dizzy, guardian with him stated that he passed out briefly and then just said he felt dizzy. He wanted to get some air so him, myself, and his mom went outside and waited for the paramedics to arrive . Once outside, patient said he felt better but a little dizzy. Paramedics came to make sure he was okay, he went to the hospital after that,
Case completed 2 dose Covid vaccine series on 3/29/21, then was hospitalized for Covid pneumonia on 8/11/2021.
Presented with worsening cough, SOB. Severe sepsis secondary to COVID-19 pneumonia  and acute respiratory failure, COVID pneumonia and suspected gram negative bacteria. Code blue called on 02/02 because of unresponsiveness. Resp status improved - adjusted O2 down to 2LRemdesivir complete. Off Veletri, S/p Actemra, Cont IV Merrem - switched from cefepime 2/5 due to AMS, Per iD pt can be dced on home O2 and on eliquis 2.5 BID, levaquin , singulair and vit D . tapered steroids
Caller was checking stability for vaccines that have been administered since an excursion; she believes all of the vaccines have been administered; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.    On an unknown dates, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T009587 with expiration date of 18-MAR-2022 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis. Other suspect therapies included hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1659422 with expiration date of 04-SEP-2022(strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # T007984 with expiration date of 01-NOV-2022. The vaccines were stored at a temperature range between 47°F to 77°F during a time frame of 7 hours and 11 minutes which were called by a data logger.
slight temperature of 99; kidney function sky rocketed/kidney function: 1.21/kidney function increase; This is a spontaneous report received from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, on 12Apr2021, as single dose, for COVID-19 immunisation. Medical history included lymphoma (large b cell), chronic obstructive pulmonary disease (COPD), blood pressure high, chronic back pain, and allergy. Concomitant medications included loratadine taken for hypersensitivity; and paracetamol (TYLENOL) taken for an unspecified indication, both start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at age 70 years, via an unspecified route of administration, on 18Mar2021, for COVID-19 immunisation. It was reported that the patient received the second dose of 12Apr2021 and had very minimal reactions (unspecified), she felt fine. On 21Apr2021, the patient underwent blood work and showed that her kidney function sky rocketed or increased. Prior to the vaccine, her kidney function was great. She reported that her kidney function prior to the vaccine was 0.69 and it was 1.21 on 21Apr2021 (a week after the second vaccine). She also reported she had a slight temperature of 99 (unspecified date) and this was nothing bad. The outcome of the event "kidney function sky rocketed/kidney function: 1.21/kidney function increase" was not recovered, while slight temperature was unknown.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurernt conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with doses of (Oka/Merck) VARIVAX, (strength dose, route, anatomical location, lot number and expiration date were not reported) which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
It started with a little red area, and then pain in my arm and hand. Went you to internist. they diagnosed me with cellulitis's , I was hospitalized for 6 days on antibiotics. and home health IV antibiotics for 6 days following.
Extreme fatigue, muscle soreness, body ache, temperature. Lasted around 10 hours and improved significantly.
Information has been received from a consumer concerning her 15-month-old daughter with no drug reactions/allergies who on 11-JAN-2005 was vaccinated SC with a 0.5 mL dose of MMR II. There was no concomitant medication. On 13-JAN-2005 the patient stopped crawling or being active at all. She would not look at her mother and became unresponsive. Her daughter has since been diagnosed with pervasive developmental disorder (not otherwise specified). It was also noted that she had a rash on her leg that "just will not disappear". MRIs and sleep studies were obtained (results not reported). The outcome was not recovered. Unspecified medical attention was sought. There was no product quality complaint. Pervasive development disorder (not otherwise specified) was considered to be an other important medical event. Additional information has been requested.
Very sore body for 2 days.  Vaccine was sept 21, blood clot in the lung by Sept 26, heart enlargement by sep 29
Within minutes of receiving the injection I began to feel dizzy. My heart rate quickly began to drop according to my Fitbit. My heart rate is normally  around 68. When the dizziness began I noted my heart rate dropped to 57 then 52 within seconds. The dizziness continued to get worse over the next minute or so until I completely lost my vision. One of the workers brought me water and within a minute of drinking my vision began to come back slowly. After sitting for another 10-15 after regaining my vision I felt better. I am concerned about getting my second dose of vaccine after this first experience. Please advise.
Immunization ordered as per one of two documents which was incomplete. RN used DTaP, IPV, Hep B combo vaccine for DTaP which was ordered. Child received DTaP and Hep B which were not needed. IPV was needed, but not ordered.
My left leg swelled up twice the size as my right leg, I went to the emergency room that is local to me. The young lady working there sent me by ambulance to the big hospital to have them run the tests to find out what was going on with my leg. I honestly cannot remember all the tests they ran; they did find a blood clot in my left leg and abdomen. They admitted me to the ICU unit of the hospital and scheduled me for surgery. They removed the blood clot in my leg and abdomen, a filter was put into my abdomen to help filter any blood clots.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question.  Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Check fluttering, felt like a heart attack, passed out and was taken in an ambulance. Lots of tests. Syncope was the determination. Six months later, I?ve been to a cardiologist twice for constant heart palpitations.
Myocardial Infarction; This is a spontaneous report from a contactable Other healthcare professional (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: 20201216-1), via an unspecified route of administration on 16Dec2020 08:15 at single dose for COVID-19 immunization, vaccine location provided as Left arm.  Medical history included arthritis and sulfa allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced myocardial infarction on 19Dec2020 23:00. The patient was hospitalized for myocardial infarction for 3 days. The patient underwent lab test which included Covid test via Nasal Swab post vaccination on 20Dec2020 with test result Negative. Therapeutic measure Cardiac cath procedure was taken as a result of myocardial infarction. The outcome of the event was recovering. This case was reported as Serious with seriousness criteria hospitalization.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported myocardial infarction and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.  However, more information is required, such as the complete medical history, clinical course, for the Company to make a more meaningful causality assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
2 to 3 days post vaccine her joints that are already affected with arthritis swelled and were painful. This pain was also accompanied by feeling of malaise. Both resolved in 4-5 days.
No reported adverse effects after vaccine was administered. Someone reported to our clinic that patient was found dead at home on Sunday
t104, vomiting for 4 days, crying diarrhea-tx motrin, APAP, tepid baths;
Regular menstrual cycles every 28 days since menses started at age 11. After receiving the Moderna vaccine, cycle came early and then came late for the next six months. Currently on a skipped cycle. No new stressors, dietary changes, illnesses, or lifestyle changes since vaccination occurred.
Three weeks later I developed severe numbness in the right side of my thigh, on my right leg.
Pt presented with hives on face, stomach, arms and legs about 5 minutes, post vax. Swelling of lips and tongue were also present. Pt was given epinephrine and Benadryl.
4/9/2021: mild headache, arm soreness, muscle aches, tiredness and chills beginning about 6pm. 4/10/2021: headache moderate, muscle aches and joint pain moderate; chills, tiredness, diarrhea beginning in the morning and ending early afternoon; 4/11/2021: woke at 5am because left arm (injection site) hurt; arm mildly swollen along with armpit lymph nodes in left arm, tiredness. 4/12 & 4/13: armpit lymph nodes still a little swollen and tender, arm tender, slight tiredness, other symptoms have resolved but lymph node swelling continues
Patient tested positive for HIV after his first Moderna test. He had a 4th gen HIV test done on 5/13 by a primary care provider as a matter of routine care since he was a new patient to them. His p24 Ag was pos, HIV-1 and HIV-2 Abs were negative. He had his second Moderna vaccine on 5/21. He was referred to me (ID physician) for further evaluation. His repeat 4th generation HIV test on 6/4/21 was negative as is his viral load and he has no risk factors for acute HIV. He has no other potential explanations for a false positive HIV test. He is an otherwise completely healthy and reliable young person.