chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pressure rise; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Pressure rise) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Throat cancer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced BLOOD PRESSURE INCREASED (Pressure rise). At the time of the report, BLOOD PRESSURE INCREASED (Pressure rise) outcome was unknown.            Patient reported that he was taking several undisclosed medication for high blood pressure, blood thinner.  Treatment information was not provided by the reporter.
16-30 hours after injection: Fatigue; 16-30 hours after injection: Headache; 16-30 hours after injection: Minor congestion; 16-30 hours after injection: Lightheadedness; 16-30 hours after injection: Soreness at injection site; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old male patient received third/booster dose of BNT162b2 (COMIRNATY; Lot Number: FF8841) via an intramuscular route of administration in the left arm on 03Nov2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (COMIRNATY; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 05Feb2021 at 15:00 (at the age of 27-years-old) and the second dose of BNT162b2 (COMIRNATY; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 25Feb2021 at 15:00 (at the age of 27-years-old) as single doses for COVID-19 immunisation. On 04Nov2021 at 07:00, 16-30 hours after injection, the patient experienced fatigue, headache, minor congestion, lightheadedness and soreness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, minor congestion, lightheadedness and soreness at injection site was resolved on an unknown date in Nov2021.
This spontaneous case, initially received on 01-Sep-2016, was reported by a health professional and concerns a 78-year-old female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 01-SEP-2016 to 01-SEP-2016. Dose regimen: 0.5 ml 1 time dose. Route of administration: Intramuscular, Batch number: WT54006. No additional suspect drugs. Special circumstances: On 01-Sep-2016, the patient was administered AFLURIA that reached 47F for 8 hours - no adverse event (special circumstances: drug administration error without adverse event). The outcome was reported as unknown. Reporter comments: The reporter considered the event as non-serious (medication error).
Severe erythema to left arm and induration about 14cm in diameter.  Lower extremities with pain on palpation of muscles.  Starting 3/7/08.  Treatment Solumedrol 125mg IM; Medrol dose pack; Xyzal Rx; Zantac and Benadryl starting 3/10/2008.
Patient under age 16 was vaccinated with Pfizer, which is a vaccine error.  He will be age 16 for second shot. Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away on a Moderna-only day. Unreported as error, found in data mining. All parties ignored the age restriction/confirmation of birthdate that was put in place to prevent this type of error.
This spontaneous report was received from a healthcare worker and refers to an unspecified amount of patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date in June 2015, the patients received GARDASIL 9 (lot #, expiration date, dose and route of administration were not reported) that was improperly stored on unspecified dates between 10-JUN-2015 through 22-JUN-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Progressively worse flu-like symptoms beginning approximately 6 hours after injection (~915pm): elevated temperature, psychosis, shivering/shakes, skin-pain, breaking to a sweat by around 5:30am. Treated with 1000mg acetaminophen at 11pm, 600mg ibuprofen at 3am, 1000mg acetaminophen at 5:30am, and 1000mg acetaminophen at noon the next day (20 hrs after injection).  Intensity of symptoms gradually subsiding and no plans for additional medication if current trajectory continues.
My voluntary muscles became spasmodic.  My muscles were tight as if in continuous firing. I had twitches in my muscles; arms, hamstrings, calves, shoulders..painful couldn't get my muscles to relax all night. I took aleve, I took Valerian an herb for muscle spasms at 4am.  I took 4 Ibuprofen 200mg at 6AM.  I didn't sleep all night.
Head ache, fever, chills, fatigue, body aches. In bed all day.  Felt like crap.
Patient reported sore arm - red and warm. COPD - mild SOB. "Feels sore".
Swollen, red knot at site of injection, radiating pain down arm, limited ability in arm PM. Patient given injection of corticosteroid at ER, MEDROL dose pak, BACTRIM DS, and VICOPROFEN.
Nosebleed lasting about 20 minutes.  4/10- 2 nosebleeds, one AM, one PM, 4/11 2 nosebleeds, one AM, one PM that lasted nearly 3 hours.  4/16 one nosebleed, in PM, 4/4/20 one nosebleed in AM.  Used gauze and pressure.  Finally learned afrin can help, so last bleed used it and it stopped relatively quickly.  All nosebleeds lasted 20-30 minutes except for the 3 hour one.  I've never had a nosebleed in my life prior to this.  I did contact the Health Xept., who to,d me to report it.  The only side effect I had with first dose on March 3 was a headache that lasted on and off for 3 weeks.  I did go 5 weeks in between dose, and save for the nosebleeds, had no other side effects, not even a sore arm.
HPI: Patient is ? having throat itchiness and tingling. Reports having headaches, and dizziness after 3 minutes from 2nd vaccine moderna. Reports her first vaccine she  did have a rash in her mouth for 3 days. She did speak with her primary care provider. He gave her a verbal authorization to have 2nd dose per patient. She did tell the nurse before that she had a reaction on prior dose. She was given a second dose of moderna.  On initial assessment she was sitting in the sun in the car with no windshield cover.  She felt nausea, headache, and overheated. Her elderly father was sitting in the back seat. He is unable to drive. Clinical Impression/Field Tx: Allergic reaction to Moderna vaccine.  Tingling and feeling of throat swelling.  Patient monitored on the field. Blood pressure stable, Heart rate stable. No wheezing or shortness of breath. No rashes noted on the exam. Symptoms resolving.  Family called. Capitan called EMS to come and evaluate due to still having tingling of the throat. Patient asked to go to the hospital to be evaluated. Pt transported to Hospital.
gotten sicker; Initial information received on 27-Sep-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non healthcare professional.  This case involves a patient (unknown age and gender) who had gotten sicker (illness), after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had gotten sicker (illness, non-serious) (unknown latency) following the administration of vaccine.  It was reported "I didn't think the flu existed anymore. No one seemed to get it last year. Only Covid. So weird. I don't get the flu shot. Every time I have, I've gotten sicker than a dog. Stopped about 10 years ago despite teaching and being around all the germs. And seriously flu was down 99% last year."  It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
101.2 fever going on 5 days, pain in arm, pain radiating from upper spine, aches all over, URI with minimal response to antihistamine, productive cough, malaise, unable to work, missed work so far 3 days.  On Z-pack antibiotic  three days.
5 doses administered more than 12 hours after 1st puncture of the vials; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 4:28 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021 at 4:28 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials). On 01-Sep-2021 at 4:28 PM, EXPIRED PRODUCT ADMINISTERED (5 doses administered more than 12 hours after 1st puncture of the vials) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 17-Aug-2021, the vial was initially stored in the refrigerator and on 31-Aug-2021 at 8:15 am, the vial was first punctured. On 01-Sep-2021 at 4:28 pm, vaccine was administered.   Treatment information was not reported.
- Fever went to 102.3 late Friday evening   - Sweating until my shirt and shorts were soaked.  - Very weak. Appetite lowered.  - Increased heart rate.  - Severe chills but my skin was burning hot.  - Extreme sensitivity to light.  - My eyeballs hurt so bad. Even now if I look to left or right I feel discomfort.  - Injection site wasnt just sore. All the way down to my wrist my arm felt like I had surgery. It is still very painful.  - Lower back pain.  - Pressure headache.  From Friday with ease Sunday
5 days after injection, patient then developed erythema, overlying skin rash, TTP, pruritus, TTP at site. Denies fever, nausea, vomiting. No previous episodes or allergic reactions to vaccine. Exam significant for Left arm with local reaction at previous vaccine injection site. + Erythema, overlying macularpapular rash, area of induration. + TTP. + Axillary lymph nodes. No edema, discharge.
Atrial Fibrillation and tachycardia.  Hospitalized for four days in September 2021, treated with medication and cardioversion.  Tachycardia returned on 10/28/2021 with an average resting heart rate of  125bpm.
Hospitalized with Diabetic Ketoacidosis, diagnosed with Type 1 Diabetes (Autoimmune disease) Lethargy, ketone breath, frequent urination, extreme weight loss, extremely high blood sugars and A1C, elevated antibodies for celiac disease (later diagnosed in Jan 2021 after endoscopy and biopsy)
Patient administered first dose of Moderna COVID-19 vaccine at the age of 17; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of Moderna COVID-19 vaccine at the age of 17) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of Moderna COVID-19 vaccine at the age of 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of Moderna COVID-19 vaccine at the age of 17) 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 Concomitant medications were reported. No Treatment medications were reported. The dentists want to knowhow they should proceed with these patients, are they able to complete the vaccination series. The second question was whether these patients could be enrolled in a clinical trial for the Moderna COVID-19 vaccine in pediatric patients.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "POEMS Syndrome (a blood cancer)" (unspecified if ongoing), notes: POEMS Syndrome (a blood cancer). Concomitant medication(s) included: LEVOTHYROXINE SODIUM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Negative; (01Jun2022) Positive; (Jun2022) Positive, notes: Was positive for another 7 days. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment start date=18May2022, treatment stop date=23May2022]. Additional information: Received Paxlovid on 18May2022. Symptoms were mild. Tested negative on 24May2022 and for one week thereafter. Reoccurring symptoms and another positive test on 01Jun2022. Symptoms more severe this time. Was positive for another 7 days. known allergies No. other medication in 2weeks Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Diagnosed with Polymyalgia Rheumatica. 6 day Medrol Pac beginning on 6/8/2021, ending on 6/13/2021. No positive outcome. All symptoms returned , in full, on 6/15/2021. Started 10 mg/day Prednisone on 6/17/2021.
Low blood platelets count; Liver enzyme number increase; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Lot number: EW0175) at the age of 58 years as dose 2, single and administered in arm left, administration date 07Apr2021 (Lot number: ER8729) as dose 1, single for covid-19 immunisation. Relevant medical history included: "mild asthma" (unspecified if ongoing), notes: mild asthma; "heart rhythm issue" (unspecified if ongoing), notes: heart rhythm issue; "Known allergies: some antibiotics" (unspecified if ongoing), notes: Known allergies: some antibiotics; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: some sea food" (unspecified if ongoing), notes: Known allergies: some sea food. There were no concomitant medications. The following information was reported: PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "Low blood platelets count"; HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "Liver enzyme number increase". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of platelet count decreased, hepatic enzyme increased.  Additional information: Low blood platelets count and liver enzyme number increase after first two Phizer mRNA shots in Apr2021 which never happened in her all blood test reports before. Patient reported to CDC site through V-safe. After 3rd vaccine shot on 04Jan2022, patient encountered COVID Toe like symptom (purple toes on left foot). Pictures taken to be showed to her primary doctor for seeking medical treatment/advice.The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Pt received the J&J vaccine at age 17 instead of the approved 18 years old.
Narrative:  1/9/23 at 15:03 - Pt presented to ED with cough, wheezing, dehydration, and confusion x 1 week per daughter. Pt noted with altered mental status (paranoia and hallucinations per daughter). Daughter also reported fever, chills, fatigue at home and not eating/drinking for last 2 days. In ED, head CT showed pansinusitis and endodontal disease. CXR showed left and small right pleural effusions with adjacent opacities. Patient tested positive for COVID-19. EKG = atrial flutter, variable av block, nonspecific stt. Pt given IV fluid, atenolol, and diltiazem. Primary diagnosis = COVID, new afib/flutter, AMS. Pt admitted to medicine floor with stay from 1/9/ to 1/16/23. Per discharge summary, PRINCIPAL DIAGNOSIS (Reason for admission after study) = atrial flutter with variable block. Additional diagnosis include: COVID 19 infection, HTN - chronic, BPH, and acute/chronic encephalopathy. HOSPITAL COURSE: pt admitted to the sdu. dx atrial flutter. ? if r/t covid. pt was given dilt in the ER with improvement of rate. pt with positive covid. pt did not require oxygen upon admission. cont to monitor. cardiology consulted - noted Atrial flutter with variable block. hx of AVNRT. - atrial flutter presenting in setting of COVID 19 infection. previously on atenolol. pt started on metoprolol q6h for rate control. unknown duration of a flutter. if stable can have DCCV in oupt setting. chadsvasc 3 - has bleed 3. concern age/risks. to be discussed with caregiver. pt with what appears to be a short period where oxygen was needed while in the SDU only. pt stable for transfer to the floor on 1/12/23. pt no longer requiring oxygen. heart rate remained stable. pt tolerating medications PT consulted - recommended 24/7 supervision at home due and reported hx of falls with decreased cognition. pt stable on medications. plan for cardiology follow up. to keep pcp follow up. consult for overnight oximetry test ordered. order for HHPT.
chest tightness, shortness of breath Narrative: Patient received second dose of Pfizer COVID19 vaccine in vaccine drive thru clinic at medical center. Developed tightness and shortness of breath. Epinephrine 0.3mg IM auto-injector administered by clinic staff and EMS was called. EMS administered methylprednisolone 125mg IM and diphenhydramine 50mg IM and transported to ED. Patient reported resolution of SOB, however had continued chest discomfort. No itching, rash, tongue swelling. No diaphoresis, N/V. CP not exertional, doesn't radiate. Hx prior CAD by LHC more than 10 years ago OSH, no stent. No prior MI. No LHC, MPS here. EF normal 2016 echo. Nitroglycerin 0.4 sublingual tab administered x2 in ED. Patient reported complete resolution of symptoms after second dose of nitroglycerin. Patient was admitted to Med Obs for further evaluation of chest pain.
Arm pain with the previous 3 doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain with the previous 3 doses) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain with the previous 3 doses). At the time of the report, PAIN IN EXTREMITY (Arm pain with the previous 3 doses) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No information on concomitant medication was reported. The patient received full dose for 1st two doses. No information on treatment medications was reported.   This case was linked to MOD-2022-525602, MOD-2022-525609, MOD-2022-525616 (Patient Link).   Reporter did not allow further contact
Vaccinated on 10-28-09-on 11-2-09 symptoms began muscle aches and pains in legs. Also ran an elevated temperature. Pain in legs continues and saw MD and was told it was a reaction to H1N1 shot. Still c/o pain in lower legs when walking stairs.
Feels weak from waste down, Left arm is weak; Feels very weak; Went home paralyzed from waste down; This spontaneous case was reported by a consumer and describes the occurrence of DIPLEGIA (Went home paralyzed from waste down) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIPLEGIA (Went home paralyzed from waste down) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Feels weak from waste down, Left arm is weak) and ASTHENIA (Feels very weak). On 20-May-2021, DIPLEGIA (Went home paralyzed from waste down) had resolved. At the time of the report, MUSCULAR WEAKNESS (Feels weak from waste down, Left arm is weak) and ASTHENIA (Feels very weak) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had cold before her second dose. Patient reported to agent that mostly her legs were affected. Patient also called EMS and they did not transport her to hospital. Patient states that she has not taken any medications to help subside the possible adverse events. No concomitant medications were mentioned.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-263043 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.