chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left common femoral venous thrombosis; This literature-study case was reported in a literature article and describes the occurrence of DEEP VEIN THROMBOSIS (Left common femoral venous thrombosis) in an 84-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEEP VEIN THROMBOSIS (Left common femoral venous thrombosis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to DEEP VEIN THROMBOSIS. The patient was treated with HEPARIN for Anticoagulant therapy, at an unspecified dose and frequency and APIXABAN for Anticoagulant therapy, at an unspecified dose and frequency. At the time of the report, DEEP VEIN THROMBOSIS (Left common femoral venous thrombosis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: thrombus in left common femoral vein (abnormal) thrombus in left common femoral vein. On an unknown date, Haematology test: hypercoagulable panel, negati (Negative) performed a hypercoagulable panel in patients which was negative for a genetic predisposition to VTE (hospital days 2-4). On an unknown date, Haemoglobin: 12.7 gm/dl (Low) 12.7  gm/dl. On an unknown date, International normalised ratio: 1.1 (Low) 1.1. On an unknown date, Platelet count: 144 per mm3 (Low) 144 per mm3. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Ultrasound Doppler: femoral, popliteal, and peroneal dvt (Inconclusive) left common femoral, popliteal, and peroneal DVT. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DEEP VEIN THROMBOSIS (Left common femoral venous thrombosis) to be possibly related. Concomitant medications were not provided by the reporter. Patient presented with 8 days left leg pain and swelling symptoms. Her symptoms occurred 3 day after second dose vaccination. Pulmonary embolism was not detected. Her symptom improved on a heparin drip and was ultimately discharged from hospital with 3 days on apixaban. 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. This case was linked to MOD-2021-282440, MOD-2021-282332; Sender'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.
ED to Hosp-Admission Discharged 7/29/2021 - 8/13/2021 (15 days) Hospital DUE TO Presenting Problem/History of Present Illness/Reason for Admission Trauma,  Fall from standing, initial encounter  He was to be discharged on 8/3 however, Covid test prior to discharge resulted positive.  He kept in hospital for 10 days during isolation.  He remained asymptomatic and his hospital course was otherwise uneventful.  On 8/13, he was discharged back to transitions nursing facility.
Temporal temperature of 101.1 ^F, oral temperature of 100.8 ^F  at 1025 (am) on 1/21/2021. Acetaminophen taken at 1100 (am). Tympanic temperature at 1600 was 98.7 ^F. No medication taken. Tympanic temperature at 1800 was 98.6 ^F.  Nausea sudden onset at 1020 (am) on 1/21/2021. Relieved at 1200 (noon) after having lunch.  Fatigue started 1/21/2021 at 0600 (am). Resolved at 1300 on 1/21/2021. Muscle aches started 1/21/2021 at 0600 (am). Resolved 1/22/2021 at 0600 (am). Chills sudden onset at 1020 (am) on 1/21/2021. Resolved 1/21/2021 by 1400. Injection site pain, localized pain on upper shoulder. Started on 1/21/2021 at 0300 (am) resolved by 1/21/2021 at 0630 (am).
spontaneous bleeding from nose; rapid heartbeat upon awakening; dose 1 on 13Jan2021 and dose 2 on 27Jan2021; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 27Jan2021 (Batch/Lot number was not reported) as dose 2, single at the age of 51 years old for COVID-19 immunisation. Medical history and concomitant medications reported as none. No known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 in left arm at the age of 51 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 29Jan2021, (2 days after the vaccination) the patient experienced rapid heartbeat upon awakening. The patient also experienced spontaneous bleeding from nose in the middle of the night on 30Jan2021 (3 days after 2nd shot). The patient has no history of nose bleeds. The patient did not receive treatment for the events. The patient recovered from the events in 2021. The events were assessed as non-serious.  Information on the lot/batch number has been requested.
Patient had a COVID vaccine on 3/13/21 and after reported to our ER department that she had an allergic reaction. She used an EpiPen and was seen at ER. She was discharged home from that ER. On 3/14/21, the patient came to the ER because she started to develop dry mouth and felt her tongue swelling (she stated this was identical to the onset of her allergic reaction the day prior). Patient used an EpiPen on 3/14/21 prior to coming to the ER. The patient did not specify which manufacturer of the vaccine she received on 3/13/21. This reaction may be reported by Hospital ER as well.
Temperature 101.8. Pain in (L) neck, behind (L) ear, (L) shoulder, (L) arm. Painful to move arm. Swelling at injection site.
States feels tired, aches and pain in joints, nausea and low grade temp occasionally. A lot of pain in her neck, back and lower hip area.
No adverse effect yet, however there may have been a faulty syringe. When injecting the vaccine I (the pharmacist) didn't feel resistance from the syringe and the needle seemed to retract sooner than usual. Kathy's initial reaction was "that was it?" as she didn't feel the injection, when speaking with her again she said she felt something...On inspection of the syringe there was more fluid than usual, possibly 0.2ml in the back of the syringe.
Fall; Sweat; Muscle cramps worse; Soreness; Poor balance worsened; Blurry vision worse; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall), HYPERHIDROSIS (Sweat), MUSCLE SPASMS (Muscle cramps worse), PAIN (Soreness) and BALANCE DISORDER (Poor balance worsened) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FALL (Fall), HYPERHIDROSIS (Sweat), MUSCLE SPASMS (Muscle cramps worse), PAIN (Soreness), BALANCE DISORDER (Poor balance worsened), VISION BLURRED (Blurry vision worse) and PYREXIA (Fever). At the time of the report, FALL (Fall), HYPERHIDROSIS (Sweat), MUSCLE SPASMS (Muscle cramps worse), PAIN (Soreness), BALANCE DISORDER (Poor balance worsened), VISION BLURRED (Blurry vision worse) and PYREXIA (Fever) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Treatment information was not provided.
Patient developed fever and myalgias 2 days after 3rd shot in rabies series. The patients symptoms progressed to bilateral ascending nerve pain and weakness in the lower extremities that progressed to the upper extremities, back, shoulders and neck over the last 4 weeks. These symptoms are starting to resolve. The patient was treated on 12 May 16 with oral prednisone and naproxen for the pain. Patient is also having urinary retention that started 24 May 16 but it is unknown at this time if this is related.
Coworker that came to work with a cold, the next day my coworker then called me and stated that she was positive for COVID-19. On Wednesday I started to feel like I was coming down with a cold. By Thursday morning I went into the doctor's office for a visit. COVID-19 test was done and I was positive. I was given a prescription for an anti-viral but it was not Paxlovid. I started taking it right away and felt bad for about 2 days. 5 days I stayed home and then afterwards I went back to work. My main symptoms were feeling fatigued and I slept a lot, low grade fever for a few days.  As of today I feel back to normal.
Patient reported fever, vomiting starting the evening of the vaccine administration (9/03/13). However, patient indicated that he is feeling a bit better (9/4/13).
patient started feeling numbness in their finger, toes, arms, and legs followed by chest pressure and near syncopal episode. Blood pressure was taken and was 151/97 with a heart rate of 94. Ambulance arrived, took vitals at pharmacy, after which patient was taken to the nearby hospital.
318 patients received dose from vials beyond 30-day use by date; 318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 06-Aug-2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 06-Aug-2021)) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 06-Aug-2021)). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) and PRODUCT STORAGE ERROR (318 patients received dose from vials beyond 30-day use by date ( In Refrigeration on 06-Aug-2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-363782 (Patient Link).
4 Days after receiving Moderna booster.  Had cardiac arrest walking  to car without exertion.,  Ventricular fibrillation.  CPR at scene with multiple shocks and Epinephrine.  Transferred to medical center where resuscitation continued but was unsuccessfull.  Previously healthy without ongoing medical problems or medications.  Non smoker.  No illicit drugs.  No history of hypertension.  No family history of sudden death or Aneurysms.  Lived with mother who declined Autopsy.  DECEASED
01Aug95 pt recv 1 dose vax. 02Feb98 pt devel chickenpox. Additional info has been requested
vaccine exposure during pregnancy; soreness in arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and PAIN IN EXTREMITY (soreness in arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 21-Jul-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and PAIN IN EXTREMITY (soreness in arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved and PAIN IN EXTREMITY (soreness in arm) outcome was unknown. Not Provided      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 concomitants were reported. No treatment was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-086821 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received on 22-Apr-2021 contains pregnancy registry form.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-086821:Case for dose 2
Patient developed cough, sore throat, and nasal congestion on 7/23/2021.  She tested positive for COVID on 7/25/2021
The evening of the vax, the pt experienced a low fever, talked incessantly, acted hyperactive , had hives, seemed delirious.
Pt call clinic 2 days after vaccination on 4 NOV 2011, complaining she is unable to move neck, pt was advised to present to the emergancy room.
02/9/2012 Patient began spitting up alot.  February 21, 2012 pt. presented to office with increased vomiting and signs of dehydration. Pt. sent to Hospital and diagnosed with intussusception.  Surgical intervention incurred.
This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 20062013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal ntiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 120 patients who, on unknown date, developed HZ in the 5th year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010592, 1703USA010593, 1703USA010594, 1703USA010596, 1703USA010597). Additional information has been requested.; Sender's Comments:  US-009507513-1703USA010321:
Patient received one dose of Vaxelis (DTaP, IPV, Hib, HepB) in addition to one dose of ActHIB at same visit. ActHIB was not indicated at this time due to Vaxelis.  Parent notified of error. Questions answered. Will follow up with parent in one day.
5 min p/ recving vax became dizzy followed by unresponsiveness, cyanosis, cold/clammy, shallow respirations, thready carotid pulse lasting 4-5 mins. P/ 20 min was alert & active s/ cyanosis. was sent to PMD.
This spontaneous report as received from a nurse refers to a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 08-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N017094, expiry date: 31-AUG-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Headache later in the day. Overnight (Tuesday) and through Thursday night, chills, sweating, fevers, exhaustion. From Wednesday through Friday, nausea. However, extreme nausea and loss of appetite Wednesday and Thursday. Exhaustion on both of those days. Did not feel okay again until Saturday, even though the vaccine was received on Tuesday. Have never experienced ANY reaction to the flu vaccine before and the vaccine has been received many, many times.
Information has been received from the parent of an 18 year old female who was vaccinated as a child (date unknown) against measles. There was no concomitant medication and the patient was never re-vaccinated against the measles. At approximately the age of 5 or 6 years old, the female patient developed measles. It was also reported that recently the patient was told that she needed to be vaccinated again since blood work showed that the "vaccine did not take the first time". Medical attention was sought. Additional information has been requested.
Barely visible rash on inner aspect both arms, lower legs, upper chest and sides of face (similar to petichae) Non prurutic.
pt recv vax 4JUL96 & that same day pt exp a large localized rxn, a rash, SOB & elevated BP;
This spontaneous report was received from a nurse who referred to a currently 23-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2010 (reported as when the patient was 16-year-old), the patient was vaccinated with a first dose of GARDASIL 9 (lot# and expiration date were not reported) for prophylaxis. On 14-NOV-2017, the patient returned to the physician's office for the second dose of GARDASIL 9. No adverse effect was reported.
Left underarm is swollen and painful. Swelling has spread to chest to nipple line. Pain started Friday after the shot continuing to Saturday. Sunday, my son noticed a ?lump? under his arm, his lymph node was swollen. Within several hours, swelling got worse. Monday morning, swelling has spread to chest down to his nipple line.  Started him on detox both Monday morning. Called the pediatrician office, it was suggested I give him ibuprofen and ice it. The office was unable to get him in for an appointment, recommended to go to prompt care if needed.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 16-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # M028553, expiry date 07-JUN-2018 (route of administration, dose and anatomical location were not reported). It was stored in the temperature from 15 Fahrenheit degrees to 46 Fahrenheit degrees for 1 hour 27 minutes. Data logger was used. There was no previous excursion. No adverse effects were reported. Additional information has been requested.
MUSCLE TIGHTNESS AND LOSS OF SENSATION IN LEFT ARM FOR LAST 3 WEEKS. SAME ARE AS VACCINATION WAS DONE.
Medication error, pt was given 2nd dose of COVID vaccine 11 days after receiving 1st dose.
I had body aches, nausea headaches, and fever 101-103 degrees. Lasted about 4-5 days.
Reports reaction started 10/5 upon waking with feeling of rapid heart beat, lightheadedness and shaky.    Was referred to local urgent care for evaluation.
Tingling sensations; Chills; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensations), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling sensations), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PARAESTHESIA (Tingling sensations) had not resolved, CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown and HEADACHE (Headache) had resolved.            No concomitant medication was reported.  No treatment medication use was reported. Patient reported after her 3hrd shot, her headache felt like she had 5 heads and when the headache subsided, she felt tingling above her right eye which hasn't gone away.   This case was linked to MOD-2021-340950, MOD-2021-340951 (Patient Link).
DIARRHEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805za, and batch number: 1805ZA expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 12-MAR-2021. This report was non-serious.