chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged, medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient experienced a stroke after he got the vaccine and was in subacute for 5 months at the time of reporting.  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. However, details regarding medical  history and concomitant medications are required for further assessment.; 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. However, details regarding medical  history and concomitant medications are required for further assessment.
Errhymatic vascular eruption at site of Varivax injection with induration. Found right thigh (lateral) 7-8 vesicular lesion
Friday March 5, 2021 patient began itching at location of injection. Small, quarter sized area of redness/swelling arose. Saturday, March 6 2021 patient experienced muscle stiffness and fatigue, rash grew to 2 inches long moving downward from injection site and still circular in shape.  Rash swollen, firm, and sore to the touch. Sunday, March 7th rash grew to 2.5 inches long and developed more ovular shape? 1.5inch wide. Still red and hive-like in appearance. Patient experienced stomach upset, insomnia, and headache. Monday, March 8th 2021 patient is nauseas, running low-grade (99.1F) temperature, experiencing chills, fatigue, brain fog. Rash is now 4 inches long, 2 inches across at widest point. Hot to the touch, but less red in appearance.
9/22 pm per mother leg red, swollen and itchy. Some tenderness. Area of edema . left thigh one inch larger than right thigh around 2/3 upper thigh. Benadryl at5/5 1-1.5 tsp q8 hours prn.
Case number PHEH2014US023773, is an initial spontaneous report from a medical assistant received on 21 Nov 2014 with a follow up information from a medical assistant received on 29 Dec 2014. This report refers to an 80-years-old female patient. On 09 Mar 2012, she had swelling in the dorsum of the left hand from a rooster. She was put on antibiotic and tetanus (manufacturer and batch number: not reported). No concomitant medication was reported. On 10 Apr 2012, she had second dose of tetanus diphtheria vaccine (other manufacturer, batch number: U3769BA, expiry date: 26 Jan 2013) at a dose of 0.5 ml in the left deltoid. On 20 Apr 2012, she was contacted to notify that she required a third tetanus in Aug 2012. The patient received FLUVIRIN (batch number: G34A4, expiry date: 30 May 2015) multidose vial intramuscularly at a dose of 0.5 ml in the left arm on 23 Oct 2014. On the same day after vaccination, the patient experienced soreness in the arm and she could not lift her arm. Her blood pressure on 21 Nov 2014 was 130/80 (right arm sitting position). She performed a lab draw for complete blood count (CBC), complete lipid, T2, thyroid stimulating hormone (TSH), vitamin D, sedimentation rate and blood creatine phosphokinase MB (CPK-MB) isoenzymes. Urinalysis revealed specific gravity as 1.030 and PH as 5. Glucose, ketones, nitrate, bilirubin and urobilinogen were nil with large number of leukocytes and small amount of blood and proteins. Culture and sensitivity was done and results were not reported. She was treated with ciprofloxacin. On 05 Dec 2014, laboratory results were rechecked. Her left arm was still hurting and she had limited ROM. Her blood pressure was 140/70 (right arm sitting position). On 16 Dec 2014, she had back pain and suspected urinary tract infection. Her weight reduced to 128 pounds from 132 pounds. Her body temperature was 97.7. Blood pressure was 126/70 (left arm in sitting position). Urinalysis on 16 Dec 2014 revealed specific gravity as 1.025, pH was 6, glucose, nitrate, bilirubin and urobilinogen were nil, ketone was 5, leukocytes were Lg (large) +++, blood: 250 (hemolyzed) and protein was 300. It was reported that events got better, but she had trouble in urinating. She was treated with MACROBID 1 DF twice daily for 10 days with no refills. The final outcome of the events was reported as condition unchanged. Seriousness and causality of the events were not reported. Follow up information from a medical assistant received on 29 Dec 2014: Updated patient demographics (weight of patient), medical history, historical drug, vaccination history, dose and site, expiry date of suspect vaccination, laboratory values, events (back pain, blood pressure increased, weight decreased, trouble urination, urinary tract infection, joint range of motion decreased) and treatment.
Arm hurts; Temperature went up to 100F; Chills; Extremely tired; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), PYREXIA (Temperature went up to 100F), CHILLS (Chills), FATIGUE (Extremely tired) and HEADACHE (Head ache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012620A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), PYREXIA (Temperature went up to 100F), CHILLS (Chills), FATIGUE (Extremely tired) and HEADACHE (Head ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurts), PYREXIA (Temperature went up to 100F), CHILLS (Chills), FATIGUE (Extremely tired) and HEADACHE (Head ache) outcome was unknown.            No concomitant medications reported by investigator   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up information received on 29-Apr-2021 contains non-significant information
Client saw black dots, didn't feel well EVMS assess. BP110/76, P71, O2Sat 99% BS 95,  Had chips and Oreo cookies for lunch. Mother came to bring child home.  Instruct for second vaccine needs to eat and drink liquids prior to vaccination. Let vaccinator of experience from first shot.
Initial report received from a nurse on 22 Dec 2010: This patient was vaccinated with MENVEO (batch number 10003) 0.5mL IM dose on 20 Dec 2010. The patient received only the MenCWY liquid conjugate component of the vaccine without being reconstituted with MenA lyophilized conjugate component. No adverse event was reported.
Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Tachycardia-Medium, Additional Details: Patient reported that she experienced side effects after receiving the vaccine.    She went to seek medical treatment and was then told that her infant had passed away.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Lot number: 005M21A) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient had no known allergies. Patient was treated with anti-viral Paxlovid for COVID-19 treatment from 09Aug2022 to 14Aug2022.; Sender's Comments: Reported events of drug ineffective and COVID-19 are considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Began with facial flushing followed pain down injection site arm followed by numbness to the hand. Feels like there is no strength in hand. Momentary dizziness.
Hot 2 inches area; Dizzy; Nausea; Headache; Itchy 2 inches area; big red 2 inches area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot 2 inches area), DIZZINESS (Dizzy), VACCINATION SITE ERYTHEMA (big red 2 inches area), NAUSEA (Nausea) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (big red 2 inches area). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot 2 inches area), DIZZINESS (Dizzy), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PRURITUS (Itchy 2 inches area). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot 2 inches area), DIZZINESS (Dizzy), VACCINATION SITE ERYTHEMA (big red 2 inches area), NAUSEA (Nausea), HEADACHE (Headache) and VACCINATION SITE PRURITUS (Itchy 2 inches area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included ice pack  for symptoms.   Reporter did not allow further contact
Local inflammatory reaction at site of varicella injection. CBC normal. Treated with cortisone cream prn.
Received Hep A vaccine at clinic 6-7-12. Was in day 8/10 of OMNICEF for pneumonia. Symptoms had resolved. On 6-8-12 began with fever and congestion. That night had about 5 min CT seizure. ED Dx: febrile sz. CXR (-) UA gm stain (-).
Following the injection there was no immediate reaction. Approximately two days later, middle of the night woke up in severe pain and immobility of right shoulder joint. Over the course of two to three weeks the severe pain subsided, but still experienced significant muscle aches, cramping, and fatigue in the right shoulder to present.
Received vaccine on 9/16/15, on morning of 9/17/15 experienced redness, edema at site of injection. Dr recommended BENADRYL 25mg capsule x one, she took it, went home and saw her own doctor next day who gave her prednisone 20mg 2 tab daily for 7 days.
Case number PHEH2015US019982, is an initial spontaneous report from a nurse received on 06 Oct 2015. This report refers to a female patient of an unknown age. Past medical history and concomitant medication were not reported. Concurrent condition included allergy to latex. She was vaccinated with FLUVIRIN (batch number and expiry date: not reported) intramuscularly on 01 Oct 2015 and experienced severe allergic reaction to vaccine because she was allergic to latex. The patient was presented to emergency department (ED) where she was treated (unspecified) and released on an unknown date. Outcome, seriousness and causality of the event were not reported. Seriousness assessment of the event allergic reactions to vaccine was upgraded based on information available in the source document.
Fever with chills, nausea accompanied with vomiting and loose stool, intense headache, dizziness, joint pain, sore throat
within a minute of each other the nurse gave 2 full doses of vaccine; hard time breathing; lightheadedness; tinnitus, ringing in ears; redness on left arm; headache; A spontaneous report was received from a relative concerning a 72-year old, female patient who received both Moderna's COVID-19 vaccine (mRNA-1273) doses within a minute of each other and experienced having a hard time breathing, headache, redness on left arm, lightheadedness, and tinnitus- ringing in ears.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. Within one minute, the nurse gave her the second dose of mRNA-1273 (Batch number not provided). The patient had a hard time breathing, bad headache, large redness on left arm, lightheadedness, and tinnitus (ringing in ears). The patient took ibuprofen (400 mg) on 14 Feb 2021 and 15 Feb 2021. On 16 Feb 2021, the patient took Advil (200 mg).   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, within a minute of each other the nurse gave 2 full doses of vaccine, was considered resolved on 14 Feb 2021. The outcomes of the events: hard time breathing, redness on left arm, lightheadedness, tinnitus-ringing in ears, and headache is unknown.; 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.
Hives on neck, shoulder and arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on neck, shoulder and arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced URTICARIA (Hives on neck, shoulder and arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, URTICARIA (Hives on neck, shoulder and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.
Patient was vaccinated with pediatric Pfizer dose (0.1 ml ) instead of adult Pfizer dose (0.3 ml ). Patient returned 21 days later for 2nd dose and was vaccinated with adult Pfizer dose (0.3 ml).
It immobilized; Swelling in hips and shoulder; swelling in his fingers, that then moved up to his shoulder, and then to the hip on the opposite; Had difficulty to work; Redness in fingers; This spontaneous case was reported by a nurse and describes the occurrence of IMMOBILE (It immobilized), JOINT SWELLING (Swelling in hips and shoulder), PERIPHERAL SWELLING (swelling in his fingers, that then moved up to his shoulder, and then to the hip on the opposite), IMPAIRED WORK ABILITY (Had difficulty to work) and ERYTHEMA (Redness in fingers) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026H21A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (IgE Asthma).   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced IMMOBILE (It immobilized), JOINT SWELLING (Swelling in hips and shoulder), PERIPHERAL SWELLING (swelling in his fingers, that then moved up to his shoulder, and then to the hip on the opposite), IMPAIRED WORK ABILITY (Had difficulty to work) and ERYTHEMA (Redness in fingers). In April 2021, IMMOBILE (It immobilized), JOINT SWELLING (Swelling in hips and shoulder), PERIPHERAL SWELLING (swelling in his fingers, that then moved up to his shoulder, and then to the hip on the opposite), IMPAIRED WORK ABILITY (Had difficulty to work) and ERYTHEMA (Redness in fingers) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.  Patient went to see a doctor and learnt about reactive arthritis after covid vaccination.  Company comment- This case concerns a 55 year old male with relevant medical history of asthma, who experienced non-serious , unexpected events of immobile, joint swelling , peripheral swelling impaired working ability and erythema which occurred 2 weeks after vaccination with the 2nd dose of Moderna Covid 19 vaccine. The re-challenge for this case is not applicable. The benefit-risk relationship of Moderna Covid 19 Vaccine is not affected by this report. Per medical reviewer's assessment and the supporting data in the SD the event immobile was downgraded to non-serious.; Sender's Comments: This case concerns a 55 year old male with relevant medical history of asthma, who experienced non-serious , unexpected events of immobile, joint swelling , peripheral swelling impaired working ability and erythema which occurred 2 weeks after vaccination with the 2nd dose of Moderna Covid 19 vaccine. The re-challenge for this case is not applicable. The benefit-risk relationship of Moderna Covid 19 Vaccine is not affected by this report. Per medical reviewer's assessment and the supporting data in the SD the event immobile was downgraded to non-serious.
ringing in his ears; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (ringing in his ears) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M2077 and 027L2074) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-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 TINNITUS (ringing in his ears) and HEADACHE (headache). At the time of the report, TINNITUS (ringing in his ears) and HEADACHE (headache) had not resolved.            This case was linked to MOD-2021-116491, MOD-2021-116491 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non significant follow up received on 07 JUN 2021, vaccination information were updated
pt recv vax & 2hr later exp itchy red papular rash on rt thigh;tx w/DPH;event resolved w/in 72hr;
Rash all over arms, stomach, legs and back, itchiness, abdominal pain, diahrea, slight fever, sweating, lack of appetite, lethargic for about a week.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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. No concomitant medication 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.     Treatment medication was not provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pinkish/red rash and hives all over stomach, back, neck, face, and head.
little bit of a sore arm; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 1 via an unspecified route of administration on 09Mar2021 14:00 as single dose for covid-19 immunization. The patient's medical history included one glass of wine before he ate dinner and concomitant medications were not reported. The patient stated that his only side effect experienced was a "little bit of a sore arm" but stated feeling fine otherwise. He stated that he exercises regularly and would like to know if it's okay for him to resume exercising following the vaccine. He also stated that he normally had one glass of wine before he ate dinner and would like to know if it is okay to do so following the vaccine. He stated he already asked the pharmacist who gave him his vaccine and was told it was okay. The outcome of event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
4 hours after Covid booster worst pelvic floor prolapse ever.  Note:  Pelvic Floor prolapse started during initial Covid-19 disease recovery.  Condition had gotten much better prior to booster.  Today, April 11, still not back to where I was at the beginning of January with prolapse, much less the improved condition just prior to booster.
PATIENT PRESENTED TODAY WITH FLU-LIKE SYMPTOMS (FEVER, MAILISE, WEAKNESS) PATIENT ADVISED TO KEEP HYDRATED
Case number PHEH2016US028372, is an initial spontaneous report received from a consumer on 26 Oct 2016. This report refers to a 63-year-old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number not reported) at a dose of 0.5 ml intramuscular on 19 Oct 2016. The patient experienced following flu like symptoms: headaches, fever, stomach issues, muscle pain, fatigue and weakness. The outcome of the event was condition unchanged. Seriousness of the events was not reported. Causality of the events was not reported.
Body had full red rash reaction around lymph nodes. Hands, feet, groin, under arms, down the arms, and sides of torso. Rash lasted 3 days.
sinuses; Vision is blurry / Don't seem to be getting better; Utterly exhausted; came down with what I thought was a cold /Cold getting worse; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (came down with what I thought was a cold /Cold getting worse), SINUS DISORDER (sinuses), VISION BLURRED (Vision is blurry / Don't seem to be getting better) and FATIGUE (Utterly exhausted) 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.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced NASOPHARYNGITIS (came down with what I thought was a cold /Cold getting worse). On an unknown date, the patient experienced SINUS DISORDER (sinuses), VISION BLURRED (Vision is blurry / Don't seem to be getting better) and FATIGUE (Utterly exhausted). At the time of the report, NASOPHARYNGITIS (came down with what I thought was a cold /Cold getting worse) and VISION BLURRED (Vision is blurry / Don't seem to be getting better) had not resolved, SINUS DISORDER (sinuses) was resolving and FATIGUE (Utterly exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.