chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm a little bit; tired; EKG indicated cluster on her heart; burning sensation in chest; Couldn't catch her breath/shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (EKG indicated cluster on her heart), DYSPEPSIA (burning sensation in chest), DYSPNOEA (Couldn't catch her breath/shortness of breath), MYALGIA (sore arm a little bit) and FATIGUE (tired) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced CARDIAC DISORDER (EKG indicated cluster on her heart), DYSPEPSIA (burning sensation in chest) and DYSPNOEA (Couldn't catch her breath/shortness of breath). On an unknown date, the patient experienced MYALGIA (sore arm a little bit) and FATIGUE (tired). At the time of the report, CARDIAC DISORDER (EKG indicated cluster on her heart), DYSPEPSIA (burning sensation in chest), DYSPNOEA (Couldn't catch her breath/shortness of breath), MYALGIA (sore arm a little bit) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Electrocardiogram: cluster on her heart (abnormal) cluster on her heart.         No concomitant medication were reported. The patient never experienced these symptoms before receiving the Moderna COVID-19 vaccine. No treatment information was reported. The patient needed further monitoring. The patient experienced burning sensation in chest and shortness of breath. The patient had an EKG and indicated had a cluster on her heart and that further monitoring was needed. Day of shots was tired and had a sore arm a little bit.
Detailed inspection - Visual lesions: wheal(s), Color: red, Shape: round, Size: 6cm, Arrangement: isolated, Distribution: localized, Side: right, Location: deltoid, Status: stable. Skin comments right deltoid SHINGRIX injection site-2 days ago. Assessment-Fatigue, unspecified type (R53.83). Patient Plan Take daily multivitamin. Will check lab today. Call on Monday for results. Rest this weekend. Symptoms are likely from the SHINGRIX vaccine. Provider Plan Patient received SHINGRIX vaccine 3 days ago and is having local reaction at site of injection. Patient also with fatigue and headache, these are listed as possible reactions to the vaccine and are likely just a reaction, however patient has a Hx of vitamin deficiency and anemia. Will check lab values. Advised to take daily MVI. Plan Orders CBC with Diff to be performed Today, Vitamin B12 and Folate to be performed Today and Vitamin D, 25-Hydroxy to be performed Today. Assessment Adverse effect of vaccine, initial encounter (T50.Z95A). Patient Plan Rest this weekend MOTRIN as needed for the pain. Provider Plan Patient had SHINGRIX vaccine on 9-19-2018. Developed indurated area approximately 6cm, painful and warm. Patient also with fatigue and headache. VAERS form completed.
it sure as hell made me sick; Initial information received on 25-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case is linked to case 2020SA300753 (original case).  This case involves patient (unknown age and gender) who had made sick as hell (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s) and family history were not provided. Concomitant medication was not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) patient reported that it might be true but it sure as hell made sick (illness) (non-serious).  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will no information on the batch number for this case.
We had a Moderna vaccine that was going to expire today  (26May2021) at 8:54am, and the vaccine was given 10 minutes after that time; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had a Moderna vaccine that was going to expire today  (26May2021) at 8:54am, and the vaccine was given 10 minutes after that time) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), AMLODIPINE BESILATE (NORVASC), NAPROXEN, GABAPENTIN and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for an unknown indication.   On 26-May-2021 at 9:04 AM, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had a Moderna vaccine that was going to expire today  (26May2021) at 8:54am, and the vaccine was given 10 minutes after that time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had a Moderna vaccine that was going to expire today  (26May2021) at 8:54am, and the vaccine was given 10 minutes after that time) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.    Reporter did not allow further contact
patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 31-year-old male 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 (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported.
Dizziness about 5 minutes after vaccination. BP 220/110, rechecked at 190/110. EMS called due to high BP. EMS came and examined pt, released her to home.
For about 3 weeks after I received my second COVID 19 vaccine, I started having seizures at night around 30 minutes after I went to sleep. This was extremally odd as until then, I had not had a Seizure since 2012, as I had grown out of my epilepsy around that time. I continued to have these seizures for 3 weeks after I got the second vaccine at a frequency of at least 3 per week. Then after about 3 weeks to a month afterwards, the seizures just stopped and have not come back since.
On the morning after Vaccine patient woke with severe Headache, muscle aches and general feeling of malaise. Arm became red with itching and soreness. Redness traveled down into bicep area. Patient took diphenhydramine and ibuprofen to alleviate the symptoms. Symptoms have improved over the week and arm is just a little red and itchy at this point. Doctor is aware of reaction.
Came into office on o 01/02/2019. Had a rash on right thigh at injection site of MMR. The upper right thigh had redness and warmth at and round injection site about half dollar in size. Physicians plan of care is to monitor site for any worsening or if parent has further concerns. Questioned whether this is a true reaction to vaccine.
I felt lethargic for 2 days and slept and could not get out of bed. I had nausea, stomach cramps, severe headache, joint ache, and swelling and pain in left finger joint and right knee. Still can not move knee after 4 days
Received vaccine 8/12/04: developed rash right away scabbed over on legs. Then rash would come and go. Rash gone by 10/03/04. No treatment . Office visit 9/29/04.
Patient complained of itchy patches / rashes on L anterior thigh, R lower forearm, w / a growing metallic taste. Patient brought to isolation, observation area where US were obtained; 98% on RA, HR of 75, 117/75 at rest. 25 mg of Benadryl given, IM in (R) deltoid. Patient observed for 30 minutes, patients reports relief post Benadryl administration .
Information has been received from a physician's office staff member concerning her daughter, a 4 year old female who on 16-MAY-2008 was vaccinated subcutaneously with a 0.5 ml second dose of VARIVAX (Merck) (LOT# 660219/0154X or 660289/1997U- the vaccine came from one of two lots, but it was not sure which one was received by the patient). Concomitant therapy included poliovirus vaccine. The patient developed swelling with warmth and redness from shoulder to elbow after receiving VARIVAX (Merck). Two days after vaccination, the patient recovered from the symptoms. The patient did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
Per patient 3 days after first covid vaccination he had bilateral hearing loss that initially started in the left ear and lasted 3 days returned for 1 day then hearing loss to both ears for 3 days. States the hearing loss did come and go during each of the three days. Denies any history of hearing loss and hearing is has since returned to normal.
Shot on Wednesday afternoon, the Rash was  noticed behind ears down sides of neck next morning with elevated temperature though out Thursday. Friday rash is itchy and has progressed down towards shoulders and chest area and moving up to chin and sides of cheeks. Prickly itchy raised bumps.
Patients have been administered doses while the temperature excursion assessment has been ongoing; Patients have been administered doses while the temperature excursion assessment has been ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment has been ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment has been ongoing) in an 81-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 (Patients have been administered doses while the temperature excursion assessment has been ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment has been ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment has been ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment has been ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were 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 her 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 this time. It was reported that no adverse reactions were reported by any patients.  No treatment medications were reported.   This case was linked to MOD-2022-501575 (Patient Link).
Info has been received from a health professional concerning a 21 year old female, that had chickenpox when younger, but had a titer drawn on 1/13/05, which was negative. The pt indicated that she has no pertinent medical history and has no drug allergies. On 2/15/05, she was vaccinated in the right arm with a 1st dose of varicella virus vaccine live. The pt stated that she was not taking any other medications. The health professional reported that on 2/15/05, the pt developed a 45mm swelling and redness of the right arm. The pt indicated that she did not call the office when her arm swelled. Just tried not to touch it. The pt also reported that it took about 1 1/2 weeks, on approximately 2/25/05, to recover post/vax. Unspecified medical attention was sought. No produce quality complaint was involved. Additional info has been requested.
10/11/18: PATIENT'S CAREGIVER CALLING TO REPORT THAT PATIENT HAD 2 VACCINES ADMINISTERED LAST WEEK (10/3/18). LEFT ARM - PNEUMOCOCCAL AND RIGHT ARM - HIGH DOSE FLU. SHE STATED THAT THE RIGHT ARM IS RED, INFLAMED, WARM TO TOUCH. PROVIDER ASKED THAT THE PATIENT APPLY ICE TID. STAFF CALLED ON 1013 ARM IS OK NOW.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 18:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Apr2021 at 18:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Nov2021 at 19:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 12Apr2022 at 19:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hereditary hemochromatosis" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; SYMBICORT. Past drug history included: Known allergies:dioxicyclin, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
11/11/05 Within the following week I could not raise my arm in a certain direction due to the pain that I felt in my muscle. By 12/8 the pain was now in my armpit, down the inside of the arm and slightly across top part of left breast. Went for EKG OK. Dr Rx cephalexin helped to rid the lymph glands of infection. But the muscle still has not recovered. Improved but still very sore.
Patient states after about 48 hours after vaccination, she experienced nausea, vomiting, diarrhea, aching legs, weakness of legs and hands, and severe chills. This lasted roughly 3 days.
Initial report received from non-healthcare professional on 12 June 2014. A patient, whose gender, age, medical history and concomitant medications not reported had received a 0.5 ml dose of FLUZONE HD (dose, dose number, lot number, route, site of vaccination not reported) on 20 December 2013. It was reported that on an unspecified date patient developed joint pain, vomiting, nausea and site pain. Lab investigation and corrective treatment details not reported. The outcome of events was not reported. Documents held by sender: None.
This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest hurt) and DYSPNOEA (trouble breathing) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 026B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced CHEST PAIN (chest hurt) and DYSPNOEA (trouble breathing). On 12-Mar-2021, CHEST PAIN (chest hurt) and DYSPNOEA (trouble breathing) had resolved. Not Provided. Patient received the vaccines in the Left Non-Dominant arm. Concomitant product use was not provided. Action taken with mRNA in the event was not applicable.
Lightheaded; Anxious; Wheals on neck; Scratchy throat; This is a spontaneous report from a contactable nurse, other health care professional. A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in right arm on 14Apr2021 13:30 (at the age of 22-years-old) (Lot Number: EW0153) as dose 1, single for covid-19 immunization at school or student health clinic facility. Medical history included anxiety, depression and polycystic ovaries (Pcos) all were started from an unknown date and unknown if ongoing. Patient had known allergies to bees, patient previously took doxycycline and experienced drug allergy. Patient received other medications within two weeks of vaccination was taken as concomitant medications which included testosterone taken for an unspecified indication, start and stop date were not reported. On 14Apr2021 13:45, patient experienced lightheaded, anxious, wheals on neck, scratchy throat and patient walked to tent. These events resulted in emergency room/department or urgent care visit via ambulance and all events were considered as medically significant due to treatment with Epinephrine, Oxygen inhalation to prevent a serious outcome. Patient was pregnant at the time of vaccination was reported as unknown. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received any other vaccines within four weeks prior to the vaccination was reported as unknown. Therapeutic measures included epinephrine 1:1000 0.5ml left thigh; oxygen 10 L via mask; diphenhydraimine 50mg IM Left deltoid, IV started were taken as a result of all events. The patient underwent lab tests and procedures which included nasal swab type, COVID-19 virus test post vaccination on 08Sep2020; on 25Jan2021 and on 05Feb2021 with negative results. The outcome of the events was recovered on 14Apr2021 at 13:45.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
RIGHT ARM SORE, RED, SWELLING, WARM TO TOUCH, R HIP PAIN Narrative:
She didn't have appetite; She felt disgusted; Vomiting; Chills; Little bit Dizzy; My hands and feet were freezing; My body was hot; Body was shaking; My body was cold; I had "heats"; Did not sleep well during the night; I did not feel well; My arm hurt; My feet were freezing; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Body was shaking), INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING COLD (My body was cold) and FEELING HOT (I had "heats") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOVASTATIN, LOSARTAN, AMLODIPINE, HYDROCHLOROTHIAZIDE, ASPIRIN [ACETYLSALICYLIC ACID] and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING HOT (I had "heats"), PAIN IN EXTREMITY (My arm hurt) and PERIPHERAL COLDNESS (My feet were freezing). On 03-Mar-2021, the patient experienced TREMOR (Body was shaking), FEELING COLD (My body was cold), FEELING COLD (My hands and feet were freezing), FEELING HOT (My body was hot ), DIZZINESS (Little bit Dizzy) and CHILLS (Chills). On an unknown date, the patient experienced DECREASED APPETITE (She didn't have appetite), FEELING ABNORMAL (She felt disgusted) and VOMITING (Vomiting). At the time of the report, TREMOR (Body was shaking), INSOMNIA (Did not sleep well during the night), MALAISE (I did not feel well), FEELING COLD (My body was cold), FEELING HOT (I had "heats"), DECREASED APPETITE (She didn't have appetite), PAIN IN EXTREMITY (My arm hurt), PERIPHERAL COLDNESS (My feet were freezing), FEELING COLD (My hands and feet were freezing), FEELING HOT (My body was hot ), FEELING ABNORMAL (She felt disgusted), DIZZINESS (Little bit Dizzy), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 02-Mar-2021, after the first shot administered, the blood pressure reading was taken with altered results. The nurse also suggested the patient to not to take Tylenol or Ibuprofen for 1 week.
RASH OVER HER BODY, TEMPERATURE 99.9. CETIRIZINE HCL 1 MG/ML SYRUP.
Fever; Fartigue; Soreness at injection site; Difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced fever, fatigue, injection site pain and difficulty sleeping. On an unknown date, the outcome of the fever, fatigue, injection site pain and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the fever, fatigue, injection site pain and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix yesterday of reporting date and was experiencing fever, fatigue, soreness at injection site and difficulty sleeping. No further details were provided. The reporter did not want to provide his address.
pt recv vax & was found to be a nonresponder;pt self-administered the vax