chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Cerebral microembolism, Chest discomfort, Chest pain, Coagulation test normal
Clinical narrative: The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating into both arms approximately 23 days following her second dose of the Pfizer vaccination.  She was taken to the cardiac cath lab after negative troponins and a negative stress test.   Two coronary stents were placed in the setting of single vessel disease.  She suffered a mild myocardial infarct during angioplasty.  The patient was transferred to the facility where I work due to persistance of bilateral arm/hand dysesthesias/numbness/tingling which did not resolve following angioplasty/stenting.  She demonstrated a poorly-definted mid-thoracic sensory level described as abdominal numbness extending to the legs.  She demonstrated widespread hyperreflexia, including crossed adduction with bilateral knee jerk reflexes.  Her presentation was consistent with acute transverse myelitis.  As of outpatient follow-up on 4/12/21 the patient had continued dysesthesias and a subjective sensory level similar to presentation.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary arterial stent insertion, Coronary artery disease, Dysaesthesia, Dyskinesia, Hyperreflexia
Clinical narrative: The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating into both arms approximately 23 days following her second dose of the Pfizer vaccination.  She was taken to the cardiac cath lab after negative troponins and a negative stress test.   Two coronary stents were placed in the setting of single vessel disease.  She suffered a mild myocardial infarct during angioplasty.  The patient was transferred to the facility where I work due to persistance of bilateral arm/hand dysesthesias/numbness/tingling which did not resolve following angioplasty/stenting.  She demonstrated a poorly-definted mid-thoracic sensory level described as abdominal numbness extending to the legs.  She demonstrated widespread hyperreflexia, including crossed adduction with bilateral knee jerk reflexes.  Her presentation was consistent with acute transverse myelitis.  As of outpatient follow-up on 4/12/21 the patient had continued dysesthesias and a subjective sensory level similar to presentation.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Magnetic resonance imaging thoracic abnormal, Musculoskeletal pain
Clinical narrative: The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating into both arms approximately 23 days following her second dose of the Pfizer vaccination.  She was taken to the cardiac cath lab after negative troponins and a negative stress test.   Two coronary stents were placed in the setting of single vessel disease.  She suffered a mild myocardial infarct during angioplasty.  The patient was transferred to the facility where I work due to persistance of bilateral arm/hand dysesthesias/numbness/tingling which did not resolve following angioplasty/stenting.  She demonstrated a poorly-definted mid-thoracic sensory level described as abdominal numbness extending to the legs.  She demonstrated widespread hyperreflexia, including crossed adduction with bilateral knee jerk reflexes.  Her presentation was consistent with acute transverse myelitis.  As of outpatient follow-up on 4/12/21 the patient had continued dysesthesias and a subjective sensory level similar to presentation.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse, Myocardial infarction, Pain, Pain in extremity, Paraesthesia
Clinical narrative: The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating into both arms approximately 23 days following her second dose of the Pfizer vaccination.  She was taken to the cardiac cath lab after negative troponins and a negative stress test.   Two coronary stents were placed in the setting of single vessel disease.  She suffered a mild myocardial infarct during angioplasty.  The patient was transferred to the facility where I work due to persistance of bilateral arm/hand dysesthesias/numbness/tingling which did not resolve following angioplasty/stenting.  She demonstrated a poorly-definted mid-thoracic sensory level described as abdominal numbness extending to the legs.  She demonstrated widespread hyperreflexia, including crossed adduction with bilateral knee jerk reflexes.  Her presentation was consistent with acute transverse myelitis.  As of outpatient follow-up on 4/12/21 the patient had continued dysesthesias and a subjective sensory level similar to presentation.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Protein C, Protein S normal, Russell's viper venom time normal, Sensory level abnormal, Troponin normal
Clinical narrative: The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating into both arms approximately 23 days following her second dose of the Pfizer vaccination.  She was taken to the cardiac cath lab after negative troponins and a negative stress test.   Two coronary stents were placed in the setting of single vessel disease.  She suffered a mild myocardial infarct during angioplasty.  The patient was transferred to the facility where I work due to persistance of bilateral arm/hand dysesthesias/numbness/tingling which did not resolve following angioplasty/stenting.  She demonstrated a poorly-definted mid-thoracic sensory level described as abdominal numbness extending to the legs.  She demonstrated widespread hyperreflexia, including crossed adduction with bilateral knee jerk reflexes.  Her presentation was consistent with acute transverse myelitis.  As of outpatient follow-up on 4/12/21 the patient had continued dysesthesias and a subjective sensory level similar to presentation.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12 normal, White matter lesion
Clinical narrative: The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating into both arms approximately 23 days following her second dose of the Pfizer vaccination.  She was taken to the cardiac cath lab after negative troponins and a negative stress test.   Two coronary stents were placed in the setting of single vessel disease.  She suffered a mild myocardial infarct during angioplasty.  The patient was transferred to the facility where I work due to persistance of bilateral arm/hand dysesthesias/numbness/tingling which did not resolve following angioplasty/stenting.  She demonstrated a poorly-definted mid-thoracic sensory level described as abdominal numbness extending to the legs.  She demonstrated widespread hyperreflexia, including crossed adduction with bilateral knee jerk reflexes.  Her presentation was consistent with acute transverse myelitis.  As of outpatient follow-up on 4/12/21 the patient had continued dysesthesias and a subjective sensory level similar to presentation.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Biopsy endometrium, Blood iron decreased, Blood test, Dysmenorrhoea
Clinical narrative: Left Arm went numb several hours  after injection. Numbness dissipated after a few days, however left hand joints were stiff for almost five weeks.  Cramping and menstrual cycle began hours after injection (after months of no cycle).  Sever cramping (very unusual) and menstruation continued with severe cramps and heavy cycle nonstop for months with fever and headache.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heavy menstrual bleeding, Hypoaesthesia, Joint stiffness, Menstruation irregular
Clinical narrative: Left Arm went numb several hours  after injection. Numbness dissipated after a few days, however left hand joints were stiff for almost five weeks.  Cramping and menstrual cycle began hours after injection (after months of no cycle).  Sever cramping (very unusual) and menstruation continued with severe cramps and heavy cycle nonstop for months with fever and headache.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Left Arm went numb several hours  after injection. Numbness dissipated after a few days, however left hand joints were stiff for almost five weeks.  Cramping and menstrual cycle began hours after injection (after months of no cycle).  Sever cramping (very unusual) and menstruation continued with severe cramps and heavy cycle nonstop for months with fever and headache.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Arthralgia, Blood immunoglobulin G, C-reactive protein, Myalgia
Clinical narrative: High fever, muscle and joint pain. Joint pain continues to this date.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: High fever, muscle and joint pain. Joint pain continues to this date.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Diarrhoea, Dizziness, Dyspnoea, Fatigue
Clinical narrative: 1_fever on and off for almost 3 days; 2_Heart inflammation or Myocarditis/Pericarditis 3_More specifically, chest pain, abnormal heart rhythms, mild diarrhea, fatigue, shortness of breath, chest pain, and lightheadedness.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate abnormal, Myocarditis, Pericarditis, Pyrexia
Clinical narrative: 1_fever on and off for almost 3 days; 2_Heart inflammation or Myocarditis/Pericarditis 3_More specifically, chest pain, abnormal heart rhythms, mild diarrhea, fatigue, shortness of breath, chest pain, and lightheadedness.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Myalgia, Petechiae
Clinical narrative: (Athletic 40 yr old female endurance athlete, 115lb, no prescription meds or hormonal birth control). Have confirmed HLA-B27 antigen disorder (autoimmune eye issues, not in flare, not on meds). Also have chronic history of low-ish iron/borderline anemia.  MILD case of blood spots / petechiae rash on both lower legs  & forearms 48 hours after both pfizer vaccines, deep muscle aches, one severe nosebleed (nosebleeds are chronic, but had been under control for some months). Feeling of blood pressure surges in large muscles, esp lower legs.  Petechiae resolved in one day and did not worsen. Nosebleed clotted normally in 5min. Consulted with family dr over telehealth & followed up with routine yearly cardio exam. No concerning pulse, headache or chest pain, did not feel need for urgent care.  Normal athletic function recovered in 3 weeks, yearly physical vitals were normal 1.5 month later.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram abnormal, Fatigue, Heart rate irregular
Clinical narrative: Heart palpitations starting day after second Covid injection. Difficulty taking deep breath- chest tightness simplistic to asthma
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Palpitations, Troponin normal, Ventricular extrasystoles
Clinical narrative: Heart palpitations starting day after second Covid injection. Difficulty taking deep breath- chest tightness simplistic to asthma
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Severe pain at site of injection, unable to raise arm for 5 days.  Gradual decrease in pain and improved mobility since then.  Continues to have pain at injection site w/ certain movements.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Electrocardiogram normal, Fibrin D dimer increased, Peripheral swelling
Clinical narrative: Swelling of hands and feet starting 6/5/2021  Started with right pinky, then the full hand. Extreme pain on wrist. On 6/10/21 feet started to swell up...a week later my other hand started to get swollen
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Nausea, Posture abnormal, Vomiting
Clinical narrative: On Saturday, April 17, 2021 client received her first dose of Pfizer COVID vaccine (LOT #EW0217 , EXP 7/15/2021) at approximately 2:20 pm. After vaccine was administered, client directed to observation area for 15 minutes. At 2:25pm, RN observed the client leaning forward in chair and noted that client was falling toward floor. Ae, RN responded at 2:25pm with  EMT. RN responded at 2:25 pm. RN found client on the floor in prone position. Client stating she needs to vomit. Client prompted to lay on one side with help of RN. Upon assessment, client alert and oriented to self, place, and situation. Client denied allergies. RN offered client Benadryl IM. Client denied stating "it makes me sick". RN gave direction to EMT to call 911. Client admits to history of "vasovagal reactions" after lab blood draw procedures. At  vitals were taken: BP: , HR: , RR:  O2 sat: %. Vitals at 2:25 pm: BP: 110/70, HR: 58, O2 sat: 98%.  Client denied shortness of breath, swelling of throat or tongue, chest pain, difficulty swallowing, palpitations, or dizziness. Nausea and vomiting resolved at 2:26 pm. Vitals at 2:31pm: BP: 114/70, HR: 59, O2 sat: 97%. At approximately 2:34pm, EMS arrived on seen. RN provided report and informed EMS that client denied benadryl. Client transported to ambulance vehicle at 2:42pm. Per EMS, client signed against medical advice and will be taken home by step mother. RN observed client until client was picked up in by step mother. Client was educated by Lead RN on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to follow up with PCP as soon as possible. Client was able to ambulate with Lead RN to her car unassisted with a steady gait at approximately pm. Client was driven by step mother.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Acute kidney injury, Diarrhoea, Gastrointestinal disorder, Laboratory test
Clinical narrative: Hospitalized with acute kidney failure due to multiple renal infarcts. Symptoms began with GI tract issues, diarrhea, abdominal pain, weight loss. Work up extensive and still in process. Symptoms persist.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Renal infarct, Weight decreased
Clinical narrative: Hospitalized with acute kidney failure due to multiple renal infarcts. Symptoms began with GI tract issues, diarrhea, abdominal pain, weight loss. Work up extensive and still in process. Symptoms persist.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure acute, Cardiomyopathy, Dyspnoea, Echocardiogram, Ejection fraction decreased
Clinical narrative: Possible myocarditis. Patient experiencing profound non-ischemic cardiomyopathy and acute CHF, without obvious other cause on preliminary investigation. Sx of fatigue, dyspnea, exercise intolerance, myalgia began 24 hours after vaccination. Myalgias resolved but CHF progressed until Dx 6/29/21. Previously an active runner.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Myalgia
Clinical narrative: Possible myocarditis. Patient experiencing profound non-ischemic cardiomyopathy and acute CHF, without obvious other cause on preliminary investigation. Sx of fatigue, dyspnea, exercise intolerance, myalgia began 24 hours after vaccination. Myalgias resolved but CHF progressed until Dx 6/29/21. Previously an active runner.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Nerve injury, Pain in extremity
Clinical narrative: Numbness and pain in both arms and into right hand and unable to write (patient is right hand dominate). Symptoms, pain, nerve damage, and inability to use bilateral upper extremities latest for three days!
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac function test, Cerebrovascular accident, Computerised tomogram abnormal, Hemiplegia
Clinical narrative: Diagnosed Stroke resulting in left side paralysis of left arm and left leg. Hospitalized for 28 days  Medical Center. Follow on with 6 weeks of in-home therapy and presently out-patient therapy both OT and PT as well as Speech. Using wheelchair and walker.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Walking aid user, Wheelchair user
Clinical narrative: Diagnosed Stroke resulting in left side paralysis of left arm and left leg. Hospitalized for 28 days  Medical Center. Follow on with 6 weeks of in-home therapy and presently out-patient therapy both OT and PT as well as Speech. Using wheelchair and walker.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lipids normal
Clinical narrative: BOTH HAND NUMB FROM WRIST TO END OF FINGER TIPS
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Groin pain, Hydrocele, Pain in extremity, Pyrexia
Clinical narrative: I started having mild testicular pain with in 24-48 hours. I also had fever of 101. I was asked to take Tylenol, which I did. The fever subsided in a day. But, the testicular pain did not go. Particularly, pain in the left side of the groin with a feeling that my left testicle might explode. It is not a constantly strong. There is a dull ache that suddenly becomes strong. It spreads into hip and leg. I was waiting for it to subside. It has not subsided. The pain got severe. I consulted my primary care physician in June. I was very shy to talk about testicle pain. So, I was waiting for it to go  He prescribed antibiotics. Even after the antibiotic course for a week, the pain did not subside. I was then referred to have both ultrasound and X-ray
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain, Ultrasound scan abnormal, Varicocele
Clinical narrative: I started having mild testicular pain with in 24-48 hours. I also had fever of 101. I was asked to take Tylenol, which I did. The fever subsided in a day. But, the testicular pain did not go. Particularly, pain in the left side of the groin with a feeling that my left testicle might explode. It is not a constantly strong. There is a dull ache that suddenly becomes strong. It spreads into hip and leg. I was waiting for it to subside. It has not subsided. The pain got severe. I consulted my primary care physician in June. I was very shy to talk about testicle pain. So, I was waiting for it to go  He prescribed antibiotics. Even after the antibiotic course for a week, the pain did not subside. I was then referred to have both ultrasound and X-ray
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff Neck
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Felt tired and arm was very sore for 72 hours.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Large itchy, tender, swollen and hard red area surrounding injection site. No treatment except icing
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site bruising, Injection site oedema, Vasodilatation
Clinical narrative: After one day, noticed bruising and edema to injection site. After 2 days noticed bruise about 6 inches below injection site as well as bruise to left thigh. On third day noticed bruising to left shin. On fifth day, noticed bruising to right forearm.  On sixth day noticed veins seems more prominent in arms. On 8th day received epidural steroid injection in lower back for pain. No further bruises noticed after that.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Myalgia
Clinical narrative: PATIENT BECAME INFECTED WITH COVID AFTER BEING FULLY VACCINATED.  SYMPTOMS STARTED 6/28/21 WITH COUGH, FATIGUE, MUSCLE ACHES, HEADACHE, AND NASAL CONGESTION.  DIAGNOSED WITH COVID ON 6/29/2021.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: PATIENT BECAME INFECTED WITH COVID AFTER BEING FULLY VACCINATED.  SYMPTOMS STARTED 6/28/21 WITH COUGH, FATIGUE, MUSCLE ACHES, HEADACHE, AND NASAL CONGESTION.  DIAGNOSED WITH COVID ON 6/29/2021.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Pyrexia
Clinical narrative: Chest pain; fever; chills; fatigue.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: weakness the day after the second dose; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9264), dose 2 via an unspecified route of administration, administered in arm left on 05Feb2021 as dose 2, single (at the age of 71-years-old) for COVID-19 immunization at Hospital. Medical history included asthma, rhinitis allergic and benign prostatic hyperplasia (BPH). Concomitant medications included FLUTICASONE, morniflumate (FLOMAX), BETHANECHOL and vitamins. Prior to the vaccination, the patient did not receive any other vaccines within four weeks and was not diagnosed with COVID-19. The patient had no known allergies. The patient previously received BNT162B2 (Lot Number: EL1283), dose 1 via an unspecified route of administration, administered in arm left on 15Jan2021 at 13:00 as dose 1, single (at the age of 71-years-old) for COVID-19 immunization at Hospital. On 06Feb2021 at 08:00, on the day after the second dose, the patient experienced weakness. No treatment was given for the event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was resolved on an unspecified date in Feb2021.  Follow-up (17May2021): Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma, Positron emission tomogram
Clinical narrative: Lymphoma; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Lymphoma) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination.     The patient's past medical history included Uterine cancer in 2011 and Hysterectomy in 2011.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHOMA (Lymphoma) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Lymphoma) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Positron emission tomogram: abnormal (abnormal) Additional groin lymphoma.         Patient had a medical history of Uterine cancer with hysterectomy since 2011. Patient Chemo therapy will  begin from 06/21/2021. Concomitant medication was not provided. No Treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Hypoaesthesia, Paraesthesia
Clinical narrative: some hearing loss; Numbness on the right of the face within five minutes of receiving treatment; tingling on right side of face; This spontaneous case was reported by a physician and describes the occurrence of DEAFNESS (some hearing loss) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050CUA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced DEAFNESS (some hearing loss) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness on the right of the face within five minutes of receiving treatment) and PARAESTHESIA (tingling on right side of face). At the time of the report, DEAFNESS (some hearing loss), HYPOAESTHESIA (Numbness on the right of the face within five minutes of receiving treatment) and PARAESTHESIA (tingling on right side of face) had not resolved.        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 medication was provided. No laboratory data was provided. No treatment medication was given.  This case concerns a 36-year-old female with a serious unexpected event of deafness, and nonserious hypoaesthesia, and paraesthesia. Event latency within 5 minutes after first dose mRNA-1273. Based on 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.; Sender's Comments: This case concerns a 36-year-old female with a serious unexpected event of deafness, and nonserious hypoaesthesia, and paraesthesia. Event latency within 5 minutes after first dose mRNA-1273. Based on 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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pericardial effusion
Clinical narrative: fluid around my heart again; Moderate swelling all over my body; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (fluid around my heart again) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Fibromyalgia, Bipolar affective disorder and Allergy to antibiotic.   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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(s). On an unknown date, the patient experienced PERICARDIAL EFFUSION (fluid around my heart again) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (Moderate swelling all over my body). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERICARDIAL EFFUSION (fluid around my heart again) and OEDEMA PERIPHERAL (Moderate swelling all over my body) had not resolved.            The action taken with mRNA-1273 in response to the event was not applicable.  The patient had right arm, leg back and left leg are all swollen and starting to get fluid around heart again. Treating with ibuprofen right now did the same after first vaccine. No concomitant medication information was provided.  Company Comment:  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.; 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.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Adrenal gland cancer, Anxiety, Cough, Depression, Fatigue
Clinical narrative: Adrenal gland tumor; Brain fog; Depression; Anxiety; Cough; Fatigue; Headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ADRENAL GLAND CANCER (Adrenal gland tumor), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), ANXIETY (Anxiety), COUGH (Cough), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADRENAL GLAND CANCER (Adrenal gland tumor) (seriousness criteria medically significant and congenital anomaly), FEELING ABNORMAL (Brain fog) (seriousness criterion congenital anomaly), DEPRESSION (Depression) (seriousness criterion congenital anomaly), ANXIETY (Anxiety) (seriousness criterion congenital anomaly), COUGH (Cough) (seriousness criterion congenital anomaly), FATIGUE (Fatigue) (seriousness criterion congenital anomaly), HEADACHE (Headache) (seriousness criterion congenital anomaly), NAUSEA (Nausea) (seriousness criterion congenital anomaly) and PYREXIA (Fever) (seriousness criterion congenital anomaly). At the time of the report, ADRENAL GLAND CANCER (Adrenal gland tumor), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), ANXIETY (Anxiety), COUGH (Cough), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.            Treatment  information was not provided by the reporter. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment Nausea, Fatigue, Headache and pyrexia are consistent with the Known safety profile of the product. for the rest of the events: Very limited information has been provided at this time.   More information about medical history and seriousness of the events was requested.; Sender's Comments: Nausea, Fatiga, Headache and pyrexia are consistent with the Known safety profile of the product. for the rest of the events: Very limited information has been provided at this time.   More information about medical history and seriousness of the events was requested.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Pyrexia
Clinical narrative: Adrenal gland tumor; Brain fog; Depression; Anxiety; Cough; Fatigue; Headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ADRENAL GLAND CANCER (Adrenal gland tumor), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), ANXIETY (Anxiety), COUGH (Cough), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADRENAL GLAND CANCER (Adrenal gland tumor) (seriousness criteria medically significant and congenital anomaly), FEELING ABNORMAL (Brain fog) (seriousness criterion congenital anomaly), DEPRESSION (Depression) (seriousness criterion congenital anomaly), ANXIETY (Anxiety) (seriousness criterion congenital anomaly), COUGH (Cough) (seriousness criterion congenital anomaly), FATIGUE (Fatigue) (seriousness criterion congenital anomaly), HEADACHE (Headache) (seriousness criterion congenital anomaly), NAUSEA (Nausea) (seriousness criterion congenital anomaly) and PYREXIA (Fever) (seriousness criterion congenital anomaly). At the time of the report, ADRENAL GLAND CANCER (Adrenal gland tumor), FEELING ABNORMAL (Brain fog), DEPRESSION (Depression), ANXIETY (Anxiety), COUGH (Cough), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.            Treatment  information was not provided by the reporter. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment Nausea, Fatigue, Headache and pyrexia are consistent with the Known safety profile of the product. for the rest of the events: Very limited information has been provided at this time.   More information about medical history and seriousness of the events was requested.; Sender's Comments: Nausea, Fatiga, Headache and pyrexia are consistent with the Known safety profile of the product. for the rest of the events: Very limited information has been provided at this time.   More information about medical history and seriousness of the events was requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Pain in extremity
Clinical narrative: some stomach cramps; Bit of dizziness; Diarrhea issues; Arm Soreness; This is a spontaneous report freceived rom a contactable other health care professional. A 61-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration and administered in left arm on 05Feb2021 10:00 (at age of 61 years) as dose 1, single for COVID-19 immunization. The patient didnot had covid-19 and was not tested for covid-19 prior vaccination. The patient was not tested covid post vaccination. The patient had no other vaccines in 4 weeks. The reporter was not aware of known allergies. The patient medical history was not reported. Concomitant medications included levothyroxine (LEVOTHYROXINE), vitamin D NOS (VITAMIN D NOS). The patient experienced arm Soreness, some diarrhea issues the first 2 days with some stomach cramps, he have a bit of dizziness that he awoke to this morning. The patient didnt received any treatment for events. The outcome of events was recovering.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; a patient was administered MMRII that expired on 15MAY2021; This spontaneous non-valid report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an 07-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) 0.5 mL, lot # S015093, expiration date 15-MAY-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. It was reported that measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) had not had any temperature excursions. No futher adverse event (AE) was reported.  This is a non-valid report due to lack of patient's identifiers.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; an expired dose of PRQUAD was inadvertently administered to a patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On 08-JUN-2021 (also reported as yesterday), the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 time dose, lot number unknown, expiration date was reported as 25-MAY-2021; anatomical location and route of administration were not reported) for prophylaxis (expired product administered). No adverse event was reported.   This is a non-valid report due to lack of patient identifier.  Upon receipt of follow-up information, it was determined that this case is now valid because patient identifier was received.   Follow up information has been received from a nurse regarding a 4 year old male patient  who on 08-JUN-2021 (also reported as yesterday), the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at  private doctor's  office hospital and a temperature excursion did not occur.
Sex: M
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: MMR antibody titer was determined to be low; Fear of delaying completion of Physician's pre-employment screening; Information has been received from a male physician reporting on himself. The patient's medical history, concurrent condition and concomitant medications were not provided.  On an unknown date in 2016, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date in 2016, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot # and expiration date were unknown) for prophylaxis.  On 05-JUN-2021, the patient had an antibody titer check as part of physician's pre-employment screening and antibody titer was determined to be low as confirmed by physician. The patient had refused to provide any additional information regarding event for fear (which he experienced on an unknown day in June 2021) of delaying completion of physician's pre-employment screening. The outcome of antibody test negative and fear was unknown.   The causality assessment was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE reported; received the vaccine from expired lot; This spontaneous report was received from an other healthcare professional (HCP) and refers to a patient of an unspecified age or gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 14-JUN-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, 0.5 ml, lot # R031629, expiration date was reported and also validated as 01-NOV-2020 (strength, route of administration and anatomical location were not provided) for prophylaxis (expired vaccine used). It was stated, that two patients came together to receive the vaccine and both received the same expired lot (split case regarding the other patient). No additional adverse event (AE) reported (no adverse event).  This is one of the two linked reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004193:
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Incorrect dose administered
Clinical narrative: presented with a Negative Antibody; RECOMBIVAX HB Pediatric/ Adolescent formulation, and Patient was inadvertently administered the RECOMBIV AX HB Adult formulation; RECOMBIV AX HB Pediatric/ Adolescent formulation, and Patient was inadvertently administered the RECOMBIV AX HB Adult formulation; presented with a Negative Antibody titer on unknown previous date and again on 04/20/2021.; This spontaneous report has been received from a health business professional referring to a male patient who would be 13-year-old at the time of the report. The patient's current conditions included Crohn's disease. The patient did not have any known drug allergies, and his concomitant therapies were unknown by the reporter.  On 04-JUL-2007, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) for prophylaxis (dose, formulation, concentration, route of administration, anatomical site of vaccination, lot number, and expiration date were not reported).   On unspecified dates in 2007, the patient was vaccinated with the second and the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB).    On an unknown date, the patient presented a negative antibody titer (Hepatitis B surface antibody negative). On 20-ABR-2021, the patient presented once again a negative antibody titer (Hepatitis B surface antibody negative).   On an unspecified date in March 2021, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) pediatric, adolescent formulation (dose, route of administration, anatomical site of vaccination, lot number, and expiration date were not reported).  On 01-JUN-2021, the patient was inadvertently vaccinated hepatitis b vaccine (recombinant) (RECOMBIVAX HB) adult formulation (route of administration, anatomical site of vaccination, lot number, and expiration date were not reported) (interchange of vaccine products), (inappropriate dose of vaccine administered).   The outcome of Hepatitis B surface antibody negative was not reported. The causality assessment between the event and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not reported.
Age: 21.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse events reported; dose of PROQUAD was given today 06/18/2021 to a 21 year old patient instead ofMMRll; dose of PROQUAD was given today 06/18/2021 to a 21 yr old patient instead ofMMRll; This spontaneous report as received from a nurse refers to a 21-year-old female patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 18-JUN-2021,  the patient was vaccinated with a dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHa, lot # T028138,0 .5 milliliter, subcutaneous for prophylaxis instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II). No treatment was given. The patient sought unspecified medical attention. No additional adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 21-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513- 2106USA006480: US-009507513- 2106USA006481: US-009507513- 2106USA006482: US-009507513- 2106USA006483: US-009507513- 2106USA006484: US-009507513- 2106USA006485: US-009507513- 2106USA006486: US-009507513- 2106USA006487: US-009507513- 2106USA006488: US-009507513- 2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513- 2106USA006458: US-009507513- 2106USA006459: US-009507513- 2106USA006460: US-009507513- 2106USA006461: US-009507513- 2106USA006462: US-009507513- 2106USA006463: US-009507513- 2106USA006464: US-009507513- 2106USA006465: US-009507513- 2106USA006466: US-009507513- 2106USA006467: US-009507513- 2106USA006468: US-009507513- 2106USA006469: US-009507513- 2106USA006470: US-009507513- 2106USA006471: US-009507513- 2106USA006472: US-009507513- 2106USA006473: US-009507513- 2106USA006474:
Age: 0.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: NO ADVERSE EVENT; baby had mistakenly received the hep a vaccine instead of a hep b vaccine; baby had mistakenly received the hep a vaccine instead of a hep b vaccine; This spontaneous report as received from a physician refers to a 7.5 months old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On 02-APR-2021 the baby had mistakenly received the hepatitis a vaccine, inactivated (VAQTA) lot # T018227 expiration date not reported, but upon internal validation established as 11-DEC-2021, instead of a hepatitis b vaccine (recombinant)(manufacturer unknown).    No adverse events were reported and nd the physician stated that "the baby was fine."
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; ROTATEQ that underwent a temperature excursion was administered; This spontaneous report was received from a physician referring to a patient of unknow age and gender patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 15-JUN-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number 1688504 and expiration date of 19-NOV-2021 for prophylaxis (dose was not reported).   The administered dose of the vaccine experienced a temperature excursion of 2°C to 8°C (9.5°C) for 0 hours 40 minutes 0 seconds, as recorded by a data logger.   There was no previous temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 21-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006497: US-009507513-2106USA006498: US-009507513-2106USA006064: