chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Declining health condition; Hand swollen; Cannot lift the arm; Physical activity significantly decreased; Infection; Inflammation; Arm pain/pain got worsened; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition) in an 85-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.     The patient's past medical history included Stent placement (stent placed before receiving the vaccine.).    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 GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition) (seriousness criterion medically significant), PERIPHERAL SWELLING (Hand swollen), MUSCLE SPASTICITY (Cannot lift the arm), DECREASED ACTIVITY (Physical activity significantly decreased), INFECTION (Infection), INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Arm pain/pain got worsened). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (Declining health condition), PERIPHERAL SWELLING (Hand swollen), MUSCLE SPASTICITY (Cannot lift the arm), DECREASED ACTIVITY (Physical activity significantly decreased), INFECTION (Infection), INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Arm pain/pain got worsened) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       The patient developed arm pain for his father couple of months back next day after receiving the first dose. The pain got worsened from then making the hand swollen and physical activity significantly decreased. The reporter contacted 3 doctors to address the concern and none could figure the reason. The reporter was concerned about his father's declining health condition and mentioned that he cannot his arm. The physician recommended not to have the second dose. First Health care provider considered as Arthritis, Second now considered as Gait and third doctor diagnosed as Infection and Inflammation.  Treatment medication include Prednisone.  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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus much increased loudness both ears, but additionally high pitched clicking sound physic intermittently, frequently throughout day and night, not improving
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Lacrimation increased
Clinical narrative: Bell Palsy right side dripping (tears) right eye
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Petechiae, Prothrombin time normal
Clinical narrative: Developed petechiae to bilateral lower extremities 3 days following vaccination. Otherwise asymptomatic at the time of evaluation.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Dyspnoea, Erythema, Rash, Swollen tongue
Clinical narrative: Patchy, red welts. Swollen tongue with tooth imprints on the sides. Voice changed to higher, more nasal pitch. Had some trouble breathing. Symptoms subsided after Benedryl.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patchy, red welts. Swollen tongue with tooth imprints on the sides. Voice changed to higher, more nasal pitch. Had some trouble breathing. Symptoms subsided after Benedryl.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Chest pain, Electrocardiogram, Fatigue, Feeling abnormal
Clinical narrative: On April 22, 2021, Pt had flu like symptoms.  On April 23, 2021 I received a text at work that pt was having chest pains.  I called his pediatrician.   We were thinking pt was still having flu like symptoms.  On Saturday, April 24, 2021, pt was still complaining about chest pains.   He was tired and not acting normal.   We took his blood pressure twice and his heart rate was 105 bpm..  Can not exactly remember blood pressure (seemed very off).  Took pt to the hospital where they measured his heart rate at 107 bpm.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: On April 22, 2021, Pt had flu like symptoms.  On April 23, 2021 I received a text at work that pt was having chest pains.  I called his pediatrician.   We were thinking pt was still having flu like symptoms.  On Saturday, April 24, 2021, pt was still complaining about chest pains.   He was tired and not acting normal.   We took his blood pressure twice and his heart rate was 105 bpm..  Can not exactly remember blood pressure (seemed very off).  Took pt to the hospital where they measured his heart rate at 107 bpm.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Condition aggravated, Irritable bowel syndrome
Clinical narrative: Random stomach cramping every couple of days. Although I am diagnosed with IBS, I generally have my symptoms under control, and my diet has not changed recently.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient- Has a mast cell disorder and can react sometimes to meds etc. At the end of 30 minutes, the patient started to get a raised red bump on leg. The Patient took 50 mg diphenhydramine and headed to Dr Office.  Physician was waiting, as patient had prearranged.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort, Inappropriate schedule of product administration, Thrombosis
Clinical narrative: had two very large blood cloths moved from her leg to her lung; blood clot was pressuring her heart; >42 days received the second vacicne; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (had two very large blood cloths moved from her leg to her lung) and CARDIAC DISCOMFORT (blood clot was pressuring her heart) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced THROMBOSIS (had two very large blood cloths moved from her leg to her lung) (seriousness criteria hospitalization, medically significant and life threatening) and CARDIAC DISCOMFORT (blood clot was pressuring her heart) (seriousness criteria hospitalization and life threatening). On 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days received the second vacicne). The patient was hospitalized from 08-Mar-2021 to 12-Mar-2021 due to CARDIAC DISCOMFORT and THROMBOSIS. On 06-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days received the second vacicne) had resolved. At the time of the report, THROMBOSIS (had two very large blood cloths moved from her leg to her lung) and CARDIAC DISCOMFORT (blood clot was pressuring her heart) 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 concomitant medications were reported. The patient was given Heparin in the hospital for about 2 days and was taking Apixaban at the time of this report.  Very limited information regarding these events has been provided at this time. Further information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information required.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: Heart palpitations, shortness of breath, head ache, tingling in right hand, sore right arm
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: I was extra tired when I woke up this morning and by 4PM felt extremely tired and really out of it. I may have a slight fever.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain in extremity
Clinical narrative: arm soreness, nausea and diarrhea
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Emotional distress, Tinnitus
Clinical narrative: patient reports pain and pressure in ears lasting about 4 weeks and currently resolved, and low pitch constant tinnitus that was severe and very distressing for the first week or so to the point that he considered harming himself.  The tinnitus persists but is less distressing.  He was treated at Urgent Care with a steroid dose pack, a course of prednisone 40 mg/day x 5 days, 10 days of augmentin 875 mg po bid and a week of cortisporin ear drops.  None of the treatment helped the tinnitus.  He refused an audiogram to evaluate the tinnitus and denies preexisting tinnitus.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: 2" red patch developed at the vaccination site on arm a week after vaccination.  The red area was warm, itchy, slightly swollen. No treatment given.  Redness resolved after 9-10 days.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Headache, Hot flush, Nausea, Oropharyngeal pain
Clinical narrative: 20 minuted after getting my second dose I started having an anaphylaxis reaction. My throat became itchy, sore and started to feel tight. I took 3 doses of benadryl to help calm the symptoms as I did not want to get stuck paying for an emergency room visit or use my EpiPen which would also result in an ER visit.  Soon after, I also  started feeling extremely  itchy all over but mainly at injection site.  My body became tingly and I had hot and cold flashes. About an hour after that, the headache, nausea and horrible body aches began. the itching at injection site stopped after 2 hours but the rest of the symptoms remained for 3 days with the exception of the headache, nausea and body aches which still remain and no amount of over the counter medication help.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pruritus, Throat irritation, Throat tightness
Clinical narrative: 20 minuted after getting my second dose I started having an anaphylaxis reaction. My throat became itchy, sore and started to feel tight. I took 3 doses of benadryl to help calm the symptoms as I did not want to get stuck paying for an emergency room visit or use my EpiPen which would also result in an ER visit.  Soon after, I also  started feeling extremely  itchy all over but mainly at injection site.  My body became tingly and I had hot and cold flashes. About an hour after that, the headache, nausea and horrible body aches began. the itching at injection site stopped after 2 hours but the rest of the symptoms remained for 3 days with the exception of the headache, nausea and body aches which still remain and no amount of over the counter medication help.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Pulmonary embolism
Clinical narrative: pulmonary embolism
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness neurosensory, Ear discomfort
Clinical narrative: Sudden sensorial hearing loss/Decreased Hearing; started to feel right ear fullness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEAFNESS NEUROSENSORY (Sudden sensorial hearing loss/Decreased Hearing) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced DEAFNESS NEUROSENSORY (Sudden sensorial hearing loss/Decreased Hearing) (seriousness criterion medically significant) and EAR DISCOMFORT (started to feel right ear fullness). At the time of the report, DEAFNESS NEUROSENSORY (Sudden sensorial hearing loss/Decreased Hearing) and EAR DISCOMFORT (started to feel right ear fullness) had not resolved.            Information about concomitant medication was not information provided. Treatment details included  steroid with Antihistamine.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: Based on current available information and the temporal association between product date and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product date and the start date of the events a causal relationship cannot be excluded.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage patient was given Pfizer vaccine
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenitis
Clinical narrative: lympatoniditis on the left auxilla, was tender to the touch, regressed in size, soft, painful but resolving over days without an issues besides APAP.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Mobility decreased
Clinical narrative: Moderna COVID-19 Vaccine EUA  Fever for 24 hours; max temp 102; temp stayed at 102 even after taking advil; severe chills and body aches for 18 hours--pain was too severe to be able to sleep; lightheaded 24 hours; fatigue for 3 days; headache for 4 days; Sore arm, unable to lift arm second day after vaccine (but that pain was less severe than body aches)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: Moderna COVID-19 Vaccine EUA  Fever for 24 hours; max temp 102; temp stayed at 102 even after taking advil; severe chills and body aches for 18 hours--pain was too severe to be able to sleep; lightheaded 24 hours; fatigue for 3 days; headache for 4 days; Sore arm, unable to lift arm second day after vaccine (but that pain was less severe than body aches)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: I was putting my son to sleep and I fell asleep for about 10 minutes. When I woke up my vision I was unable to see clearly from my right eye. It was extremely blurry. It lasted for about 2-3 hours at which point I went to sleep. When I woke up the next morning my vision was completely restored.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash broke out on chest the day after first dose and became worse after second dose. Rash went halfway up neck to each collar bone (not all the way to arms or top of shoulders), and down to just above breasts. Itchy, but not painful.  The rash is still present and skin still appears red sometimes. I will have to see a doctor soon.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Big red patch near vaccination site on shoulder. Shoulder is inflamed, painful, and hot to the touch.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient said that when she first received her dose 1, she had a slight tingling in her tongue. She said that is was not anaphylactic, she said she is allergic to bee's and it was nothing like that. She received her second dose today 5-13-21 and had no issues.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Urticaria
Clinical narrative: Hives for 2 days after, tingling lips several hours after
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypertension
Clinical narrative: Uncontrolled high blood pressure after second vaccination shot.  Have no history of high blood pressure prior.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Muscular weakness, Pain, Pain in extremity, Rotator cuff syndrome
Clinical narrative: I have been experiencing shoulder tendonitis since my first dose of the Moderna vaccine on 1/5/21. It has gotten a little worse since my second dose on 2/2/21. I have lost range of motion and experience weakness in my left arm as a result and occasionally have shooting pains through my left arm as well, especially when trying to reach for something. NONE of these symptoms existed before receiving the first dose of the Moderna COVID vaccination and I have never had such a reaction to any other vaccination, and I get a flu shot every year. Since it has been several months since I had the initial vaccination, I AM CONCERNED THAT I WILL NEVER RECOVER FULL RANGE OF MOTION IN MY LEFT ARM AND I CONSIDER THAT A DISABILITY THAT WOULD NOT HAVE OCCURRED IF I HAD NOT RECEIVED THE COVID-19 VACCINATION.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest 5/12/21
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Intentional product use issue, Loss of personal independence in daily activities, Lymphadenopathy
Clinical narrative: Went hiking and got a blood clot; beyond 36 days since first dose without receiving second dose; Interfered with work; Glands got super swollen; Trunk Rash; Excruciating headaches for three days; Extremely fatigued; High temperature; Nauseous; Ringing in ears; Taste buds changed; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Went hiking and got a blood clot) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Grover's disease. Concurrent medical conditions included Allergy NOS (allergies for which she has an epi pen) and Premenopausal symptoms (Rashes with premenopausal condition).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced TINNITUS (Ringing in ears), TASTE DISORDER (Taste buds changed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfered with work), LYMPHADENOPATHY (Glands got super swollen), RASH (Trunk Rash), HEADACHE (Excruciating headaches for three days), FATIGUE (Extremely fatigued), PYREXIA (High temperature) and NAUSEA (Nauseous). On 30-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (beyond 36 days since first dose without receiving second dose). On 01-May-2021, the patient experienced THROMBOSIS (Went hiking and got a blood clot) (seriousness criterion medically significant). On 30-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (beyond 36 days since first dose without receiving second dose) had resolved. At the time of the report, THROMBOSIS (Went hiking and got a blood clot), TINNITUS (Ringing in ears), TASTE DISORDER (Taste buds changed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfered with work), LYMPHADENOPATHY (Glands got super swollen), RASH (Trunk Rash), HEADACHE (Excruciating headaches for three days), FATIGUE (Extremely fatigued), PYREXIA (High temperature) and NAUSEA (Nauseous) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided. Company Comment  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of rash, fatigue, pyrexia, lymphadenopathy and headache.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rash, SARS-CoV-2 test, Taste disorder
Clinical narrative: Went hiking and got a blood clot; beyond 36 days since first dose without receiving second dose; Interfered with work; Glands got super swollen; Trunk Rash; Excruciating headaches for three days; Extremely fatigued; High temperature; Nauseous; Ringing in ears; Taste buds changed; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Went hiking and got a blood clot) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Grover's disease. Concurrent medical conditions included Allergy NOS (allergies for which she has an epi pen) and Premenopausal symptoms (Rashes with premenopausal condition).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced TINNITUS (Ringing in ears), TASTE DISORDER (Taste buds changed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfered with work), LYMPHADENOPATHY (Glands got super swollen), RASH (Trunk Rash), HEADACHE (Excruciating headaches for three days), FATIGUE (Extremely fatigued), PYREXIA (High temperature) and NAUSEA (Nauseous). On 30-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (beyond 36 days since first dose without receiving second dose). On 01-May-2021, the patient experienced THROMBOSIS (Went hiking and got a blood clot) (seriousness criterion medically significant). On 30-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (beyond 36 days since first dose without receiving second dose) had resolved. At the time of the report, THROMBOSIS (Went hiking and got a blood clot), TINNITUS (Ringing in ears), TASTE DISORDER (Taste buds changed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfered with work), LYMPHADENOPATHY (Glands got super swollen), RASH (Trunk Rash), HEADACHE (Excruciating headaches for three days), FATIGUE (Extremely fatigued), PYREXIA (High temperature) and NAUSEA (Nauseous) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided. Company Comment  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of rash, fatigue, pyrexia, lymphadenopathy and headache.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Tinnitus
Clinical narrative: Went hiking and got a blood clot; beyond 36 days since first dose without receiving second dose; Interfered with work; Glands got super swollen; Trunk Rash; Excruciating headaches for three days; Extremely fatigued; High temperature; Nauseous; Ringing in ears; Taste buds changed; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Went hiking and got a blood clot) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Grover's disease. Concurrent medical conditions included Allergy NOS (allergies for which she has an epi pen) and Premenopausal symptoms (Rashes with premenopausal condition).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced TINNITUS (Ringing in ears), TASTE DISORDER (Taste buds changed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfered with work), LYMPHADENOPATHY (Glands got super swollen), RASH (Trunk Rash), HEADACHE (Excruciating headaches for three days), FATIGUE (Extremely fatigued), PYREXIA (High temperature) and NAUSEA (Nauseous). On 30-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (beyond 36 days since first dose without receiving second dose). On 01-May-2021, the patient experienced THROMBOSIS (Went hiking and got a blood clot) (seriousness criterion medically significant). On 30-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (beyond 36 days since first dose without receiving second dose) had resolved. At the time of the report, THROMBOSIS (Went hiking and got a blood clot), TINNITUS (Ringing in ears), TASTE DISORDER (Taste buds changed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interfered with work), LYMPHADENOPATHY (Glands got super swollen), RASH (Trunk Rash), HEADACHE (Excruciating headaches for three days), FATIGUE (Extremely fatigued), PYREXIA (High temperature) and NAUSEA (Nauseous) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided. Company Comment  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of rash, fatigue, pyrexia, lymphadenopathy and headache.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache
Clinical narrative: Shortness of breath  Extreme headache/pressure
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Hemiplegia
Clinical narrative: Left Hemispheric Stroke with Right Hemiplegia and loss of speech.   5 days after 2nd dose of Moderna.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Myalgia
Clinical narrative: Pt developed muscle pain  about 3-4 days  after vaccination.  She didn't feel pain initially but started feeling pain and pain still persists after 3 weeks.  She cannot move her arm.  The location is not where she got vaccinated but below.  There is no lump or redness.  Pt still wanted to get 2nd dose and got vaccinated on right deltoid on 5/12/21.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Thrombosis
Clinical narrative: I received my 2nd vaccine and My period came 5 days early and I am bleeding heavy and clotting quarter size clots. Started about 8:30pm on 5/13/2021.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: temperature excursion with vaccine administration
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: I woke up on April 23 (8 days after my vaccine) with a rash on my upper, inner legs. It was slightly raised and red in color. On the 24th I woke up to a little bit more of the rash. It spread to the front of my left leg. I also had a few spots on both hands on palms and on the back of my hands. I had very few spots on my feet, but my feet were extremely itchy.  Woke up on the 25th and nothing seemed to have changed. On the 26th as the day went on the spots got lighter. This continued another day or 2 until the rash was completely gone.  I was never seen by a professional.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: high pitched tinitus in both ears.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Dizziness, Fatigue, Menstrual disorder, Nausea
Clinical narrative: Major fatigue, light headed/dizziness, missed period , extreme nausea and fatigue
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Myalgia, Nausea, Vomiting
Clinical narrative: Nausea, muscle pain throughout body for the first 12 hours Unusually delirious dreams Vomiting second night After vomiting and normal sleep, rapid recovery
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy (a neurological condition where drooping of the eye lid and the face happens); This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy (a neurological condition where drooping of the eye lid and the face happens)) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, LOVASTATIN, QUETIAPINE FUMARATE (SEROQUEL) and TRAZODONE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced BELL'S PALSY (Bell's palsy (a neurological condition where drooping of the eye lid and the face happens)) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy (a neurological condition where drooping of the eye lid and the face happens)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No adverse event as Medical History was reported.  Patient did not receive the second dose of the vaccine due to this condition.  Treatment information not provided.  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.; 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.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: PATIENT RECEIVED COVID VACCINE MIXED WITH BACTERIOSTATIC 0.9% NORMAL SALINE INSTEAD OF PLAIN NORMAL SALINE 0.9%
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Bleeding in-between periods. Not a lot, but enough and unusual.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: PATIENT RECEIVED COVID VACCINE MIXED WITH BACTERIOSTATIC 0.9% NORMAL SALINE INSTEAD OF PLAIN NORMAL SALINE 0.9%. THIS WAS DISCOVERED ON 5.12.21
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Rash pruritic
Clinical narrative: ?Covid? arm: big rash on left arm at injection site. Lasted 3-4 days. Didn?t hurt but was itchy and hot for a couple if days.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever, muscle aches, fatigue lasting 24 hours.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Dyspepsia, Gastritis, Helicobacter test
Clinical narrative: Gastritis with potential peptic ulcers. Began with severe heartburn and stomach pain the day after vaccination. Went to two emergency rooms, a visit with primary care provider, underwent blood testing (inconclusive), H. Pylori breath testing (negative),  and am scheduled for an upper endoscopy, HIDA scan, and GI visit.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: Patient passed out while on her 15 minutes of observation after the vaccine , she woke up quickly and  threw up ,she was conscious , her dad was with her all the time, we offered her the  first aids  , she was feeling  well after approximately 20 minutes.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Generalised tonic-clonic seizure, Hyperhidrosis, Memory impairment
Clinical narrative: doesn't remember anything; muscle spasms in back and legs; very tired; very sore; fever; grand mal seizures; sweating and being soak and wet; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epilepsy (The patient has a history of grand mal, petit mal and stress seizures. Patient stated that he has at least one minor seizure once a month and the last seizure he had with this great intensity was about 3 to 4 months ago.) and Drug allergy (aspirin). Concomitant products included MIDAZOLAM for Seizure, CLOBAZAM (ONFI), ESLICARBAZEPINE ACETATE (APTIOM) and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) (seriousness criterion medically significant). 04-May-2021, the patient experienced HYPERHIDROSIS (sweating and being soak and wet) and PYREXIA (fever). On 05-May-2021, the patient experienced MEMORY IMPAIRMENT (doesn't remember anything), MUSCLE SPASMS (muscle spasms in back and legs), FATIGUE (very tired) and MYALGIA (very sore). On 05-May-2021, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) had resolved. At the time of the report, HYPERHIDROSIS (sweating and being soak and wet), MEMORY IMPAIRMENT (doesn't remember anything), MUSCLE SPASMS (muscle spasms in back and legs), FATIGUE (very tired), MYALGIA (very sore) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Blood test: unknown (Inconclusive) Result not provided.         It was reported that the patient took midazolam and swiped his magnet across his vagus nerve stimulator (VNS) for treatment.  Action taken with mRNA-1273 in response to the event was Not Applicable   It was reported that the patient was asymptomatic after first dose and experienced symptoms on 04May2021 at midnight after second dose of vaccine.  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. The medical history of epilepsy was assessed as strong cofounder.; 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. The medical history of epilepsy was assessed as strong cofounder.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Pyrexia
Clinical narrative: doesn't remember anything; muscle spasms in back and legs; very tired; very sore; fever; grand mal seizures; sweating and being soak and wet; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epilepsy (The patient has a history of grand mal, petit mal and stress seizures. Patient stated that he has at least one minor seizure once a month and the last seizure he had with this great intensity was about 3 to 4 months ago.) and Drug allergy (aspirin). Concomitant products included MIDAZOLAM for Seizure, CLOBAZAM (ONFI), ESLICARBAZEPINE ACETATE (APTIOM) and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) (seriousness criterion medically significant). 04-May-2021, the patient experienced HYPERHIDROSIS (sweating and being soak and wet) and PYREXIA (fever). On 05-May-2021, the patient experienced MEMORY IMPAIRMENT (doesn't remember anything), MUSCLE SPASMS (muscle spasms in back and legs), FATIGUE (very tired) and MYALGIA (very sore). On 05-May-2021, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) had resolved. At the time of the report, HYPERHIDROSIS (sweating and being soak and wet), MEMORY IMPAIRMENT (doesn't remember anything), MUSCLE SPASMS (muscle spasms in back and legs), FATIGUE (very tired), MYALGIA (very sore) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Blood test: unknown (Inconclusive) Result not provided.         It was reported that the patient took midazolam and swiped his magnet across his vagus nerve stimulator (VNS) for treatment.  Action taken with mRNA-1273 in response to the event was Not Applicable   It was reported that the patient was asymptomatic after first dose and experienced symptoms on 04May2021 at midnight after second dose of vaccine.  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. The medical history of epilepsy was assessed as strong cofounder.; 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. The medical history of epilepsy was assessed as strong cofounder.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise
Clinical narrative: 2 episodes of pass out whom got the second dose; 3 patients felt unwell whom got the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the second dose) (seriousness criterion medically significant) and MALAISE (3 patients felt unwell whom got the first dose). At the time of the report, LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the last dose) and MALAISE (3 patients felt unwell whom got the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Very limited information regarding these events has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional event of malaise reported, 5 total cases reported, event dates provided On 30-Apr-2021: No new information; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise
Clinical narrative: 2 episodes of pass out whom got the second dose; 3 patients felt unwell whom got the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the second dose) (seriousness criterion medically significant) and MALAISE (3 patients felt unwell whom got the first dose). At the time of the report, LOSS OF CONSCIOUSNESS (2 episodes of pass out whom got the last dose) and MALAISE (3 patients felt unwell whom got the first dose) 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.   Treatment was unknown.  This case concerns an adult patient of unknown age and gender with a serious unexpected event of loss of consciousness, and nonserious unexpected malaise. Latency within 1 day 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Significant: No of patients and events given
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia oral, Inappropriate schedule of product administration
Clinical narrative: Bell's Palsy; Numbness in her gums in her mouth; Missed 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (Numbness in her gums in her mouth) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose). At the time of the report, BELL'S PALSY (Bell's Palsy) and HYPOAESTHESIA ORAL (Numbness in her gums in her mouth) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was on several unknown medications daily. Treatment includes 60mg Prednisone for 7 days and many unknown medication for treatment   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events( Bell's palsy and hypoaesthesia oral) , a causal relationship cannot be excluded. This report also refers to a case of inappropriate schedule of product administration for mRNA-1273
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chills, Chronic obstructive pulmonary disease, Dyspnoea, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma) and DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heavy smoker in 2020.   On 01-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) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On 03-May-2021, the patient experienced PRURITUS (Feeling scratchy). On 04-May-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criterion medically significant), ASTHMA (Asthma) (seriousness criterion medically significant), DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) (seriousness criterion medically significant) and WHEEZING (Wheezing sounds). On 02-May-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 03-May-2021, PRURITUS (Feeling scratchy) had resolved. On 06-May-2021, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), DYSPNOEA (Difficulty breathing which started in the morning and got worst by evening / Barely catch his breath) and WHEEZING (Wheezing sounds) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Oxygen saturation: 91 Low.         On 03-May-2021, the patient was feeling scratchy and mentioned it could be due to pollen. On 04-May-2021, he was experiencing difficulty breathing, which began in the morning and exacerbated by the evening. He had wheezing sound and by 6 PM he could barely catch his breath. He got breathing treatment using nebulizer and his oxygen level was 91. By 8 PM he went to the ER  and underwent tests. He was diagnosed to have Asthma and COPD.  Treatment: Inhaler, nebulizer and steroid.  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.