chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Urticaria, Vision blurred
Clinical narrative: Tremors; Can hardly stand up; Blurred vision; Itching everywhere; Burning of the skin; Light headedness, dizziness; Weakness; Hives; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Tremors), DYSSTASIA (Can hardly stand up), VISION BLURRED (Blurred vision), PRURITUS (Itching everywhere) and SKIN BURNING SENSATION (Burning of the skin) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.) Concomitant products included PREDNISONE for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced TREMOR (Tremors), DYSSTASIA (Can hardly stand up), VISION BLURRED (Blurred vision), PRURITUS (Itching everywhere), SKIN BURNING SENSATION (Burning of the skin), DIZZINESS (Light headedness, dizziness), ASTHENIA (Weakness) and URTICARIA (Hives). At the time of the report, TREMOR (Tremors), DYSSTASIA (Can hardly stand up), VISION BLURRED (Blurred vision), PRURITUS (Itching everywhere), SKIN BURNING SENSATION (Burning of the skin), DIZZINESS (Light headedness, dizziness), ASTHENIA (Weakness) and URTICARIA (Hives) 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.   Concomitant product use was not provided by the reporter.  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.; Reporter'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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: This spontaneous case was reported by a physical therapist (subsequently medically confirmed) and describes the occurrence of CHILLS and VOMITING in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (Severe chills) and VOMITING (Vomiting). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, CHILLS (Severe chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: horrible itching on the arm where the vaccine was given/itches like wildfire; large red area; Hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (horrible itching on the arm where the vaccine was given/itches like wildfire), VACCINATION SITE ERYTHEMA (large red area) and VACCINATION SITE WARMTH (Hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PRURITUS (horrible itching on the arm where the vaccine was given/itches like wildfire), VACCINATION SITE ERYTHEMA (large red area) and VACCINATION SITE WARMTH (Hot). At the time of the report, VACCINATION SITE PRURITUS (horrible itching on the arm where the vaccine was given/itches like wildfire), VACCINATION SITE ERYTHEMA (large red area) and VACCINATION SITE WARMTH (Hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy chorionic villous, Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Pregnancy (Live, full-term birth) on 28-Dec-2017. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Mar-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Biopsy chorionic villous: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Prenatal vitamins. Treatment details Fertility treatments Estimated date of conception in 2020. Patient had previous pregnancy on 2017 with live birth.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis
Clinical narrative: Probable cellulitis; A spontaneous report was received from a consume concerning a 86 year old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed cellulitis, described as itchy arm/pruritus, red arm/erythema, inflamed arm/inflammation, hot arm/feeling hot, and sore arm/pain in extremity.  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 30 Jan 2021, approximately ten days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient's arm began feeling itchy, red, inflamed, hot, and sore.  The patient was diagnosed with probable cellulitis.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events itchy, red, inflamed, hot, and sore arm and cellulitis were not reported.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Very limited information regarding this events has been provided at this time.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pruritus, Rash vesicular
Clinical narrative: itching; Vesicular papular rash that continues to progress; Arthralgia; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (itching), RASH VESICULAR (Vesicular papular rash that continues to progress) and ARTHRALGIA (Arthralgia) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced ARTHRALGIA (Arthralgia). On 11-Jan-2021, the patient experienced RASH VESICULAR (Vesicular papular rash that continues to progress). On 20-Jan-2021, the patient experienced PRURITUS (itching). The patient was treated with HYDROCORTISONE (topical) on 20-Jan-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, PRURITUS (itching) and ARTHRALGIA (Arthralgia) outcome was unknown and RASH VESICULAR (Vesicular papular rash that continues to progress) 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.   Concomitant medication included unspecified birth control pills.  Treatment included and antihistamine medicine. It did not help. The patient had planned to go to Dermatologist on 26-Jan-2021.  It was reported that rash was attributed to keto diet rush.  It was reported that the patient had events due to something else and gone on cessation.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: iNarrative updated with other contributing factor (keto diet rush). On 19-Jun-2021: Clinical course information updated.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Malaise
Clinical narrative: not feeling well; flu like symptoms; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reported.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache). At the time of the report, MALAISE (not feeling well), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Patient's contact updated
Sex: F
Vaccine: COVID19
Symptoms: Ligament sprain, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: upper part of deltoid got red; very hot to touch; a little bit swollen; injection site swelling; itching; little bit of redness; This spontaneous case was reported by a medical assistant (subsequently medically confirmed) and describes the occurrence of LIGAMENT SPRAIN (upper part of deltoid got red), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (little bit of redness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IRBESARTAN, AMLODIPINE, PANTOPRAZOLE, MULTIVITAMIN MULTIMINERAL and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (little bit of redness). On 15-Jan-2021, the patient experienced LIGAMENT SPRAIN (upper part of deltoid got red), VACCINATION SITE WARMTH (very hot to touch) and VACCINATION SITE SWELLING (a little bit swollen). On 11-Jan-2021, VACCINATION SITE PRURITUS (itching) was resolving. At the time of the report, LIGAMENT SPRAIN (upper part of deltoid got red), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE SWELLING (injection site swelling), VACCINATION SITE ERYTHEMA (little bit of redness) and VACCINATION SITE SWELLING (a little bit swollen) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Dyspnoea, Gait disturbance
Clinical narrative: Numb legs; Mild nausea; headache; Wobbly legs, legs could not hold me up; Diarrhea; Stomach ache; Arm hurting, pain in thigh; Jaw pain; neck pain; Pain in Back; Shortness Of Breath; difficulty breathing; A spontaneous report was received from a consumer concerning a 71 year old, female patient who experienced mild nausea/nausea, diarrhea, stomach ache/abdominal pain upper, mild headache/headache, arm and thigh hurting/pain in extremity, jaw pain, neck pain, wobbly leg and legs could not hold her up/ gait disturbance, back pain, short of breath/dyspnea, and numb legs/hypoaethesia.    The patient's medical history included chronic obstructed pulmonary disease and arthritis. Concomitant product use was not provided.   On 24-Feb-2021, approximately hours prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 24-FEB-2021 the patient had mild nausea, diarrhea, stomachache, mild headache, arm hurting, pain in the jaw to neck, wobbly legs, pain in thigh, back pain, shortness of breath, left lung was paralyzed for 20 minutes and then right lung. Then on 27-FEB-2021 the patient had severe headache, violent nausea. The patient described it as fireworks inside her, wobbly legs, and numb legs.   Treatment information included acetaminophen.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event(s) were considered recovered.; Reporter'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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nausea, Neck pain, Pain in extremity
Clinical narrative: Numb legs; Mild nausea; headache; Wobbly legs, legs could not hold me up; Diarrhea; Stomach ache; Arm hurting, pain in thigh; Jaw pain; neck pain; Pain in Back; Shortness Of Breath; difficulty breathing; A spontaneous report was received from a consumer concerning a 71 year old, female patient who experienced mild nausea/nausea, diarrhea, stomach ache/abdominal pain upper, mild headache/headache, arm and thigh hurting/pain in extremity, jaw pain, neck pain, wobbly leg and legs could not hold her up/ gait disturbance, back pain, short of breath/dyspnea, and numb legs/hypoaethesia.    The patient's medical history included chronic obstructed pulmonary disease and arthritis. Concomitant product use was not provided.   On 24-Feb-2021, approximately hours prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 24-FEB-2021 the patient had mild nausea, diarrhea, stomachache, mild headache, arm hurting, pain in the jaw to neck, wobbly legs, pain in thigh, back pain, shortness of breath, left lung was paralyzed for 20 minutes and then right lung. Then on 27-FEB-2021 the patient had severe headache, violent nausea. The patient described it as fireworks inside her, wobbly legs, and numb legs.   Treatment information included acetaminophen.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event(s) were considered recovered.; Reporter'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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Numb legs; Mild nausea; headache; Wobbly legs, legs could not hold me up; Diarrhea; Stomach ache; Arm hurting, pain in thigh; Jaw pain; neck pain; Pain in Back; Shortness Of Breath; difficulty breathing; A spontaneous report was received from a consumer concerning a 71 year old, female patient who experienced mild nausea/nausea, diarrhea, stomach ache/abdominal pain upper, mild headache/headache, arm and thigh hurting/pain in extremity, jaw pain, neck pain, wobbly leg and legs could not hold her up/ gait disturbance, back pain, short of breath/dyspnea, and numb legs/hypoaethesia.    The patient's medical history included chronic obstructed pulmonary disease and arthritis. Concomitant product use was not provided.   On 24-Feb-2021, approximately hours prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 24-FEB-2021 the patient had mild nausea, diarrhea, stomachache, mild headache, arm hurting, pain in the jaw to neck, wobbly legs, pain in thigh, back pain, shortness of breath, left lung was paralyzed for 20 minutes and then right lung. Then on 27-FEB-2021 the patient had severe headache, violent nausea. The patient described it as fireworks inside her, wobbly legs, and numb legs.   Treatment information included acetaminophen.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event(s) were considered recovered.; Reporter'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.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: slightly itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (slightly itchy) and RASH (Rash) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Jan-2021, the patient experienced RASH PRURITIC (slightly itchy) and RASH (Rash). At the time of the report, RASH PRURITIC (slightly itchy) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Headache, Pain in extremity
Clinical narrative: Swollen; Red; Sore arm; Itchy; Warm; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen), ERYTHEMA (Red), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy) and FEELING HOT (Warm) in a female patient of an unknown age 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 COVID-19.    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 SWELLING (Swollen). an unknown date, the patient experienced ERYTHEMA (Red), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy), FEELING HOT (Warm), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, SWELLING (Swollen), ERYTHEMA (Red), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy), FEELING HOT (Warm), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant  medication was provided by the reporter. No treatment medication was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Swollen; Red; Sore arm; Itchy; Warm; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen), ERYTHEMA (Red), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy) and FEELING HOT (Warm) in a female patient of an unknown age 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 COVID-19.    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 SWELLING (Swollen). an unknown date, the patient experienced ERYTHEMA (Red), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy), FEELING HOT (Warm), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, SWELLING (Swollen), ERYTHEMA (Red), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy), FEELING HOT (Warm), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant  medication was provided by the reporter. No treatment medication was provided by the reporter.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vomiting
Clinical narrative: vomiting; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and FATIGUE (fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 VOMITING (vomiting) and FATIGUE (fatigue). At the time of the report, VOMITING (vomiting) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Vomiting
Clinical narrative: sick; High fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), PYREXIA (High fever) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), PYREXIA (High fever) and VOMITING (vomiting). At the time of the report, ILLNESS (sick), PYREXIA (High fever) and VOMITING (vomiting) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 VACCINATION SITE PAIN (pain arm). At the time of the report, VACCINATION SITE PAIN (pain arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Burning eyes; Leg aches; Fever; Fatigue; Headache; Can't lift my arm/swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning eyes), PAIN IN EXTREMITY (Leg aches), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache) in a  patient of an unknown age and gender 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 was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE IRRITATION (Burning eyes), PAIN IN EXTREMITY (Leg aches), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE SWELLING (Can't lift my arm/swelling). At the time of the report, EYE IRRITATION (Burning eyes), PAIN IN EXTREMITY (Leg aches), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE SWELLING (Can't lift my arm/swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Additional information received Added Events headache, fatigue, Vaccination site swelling and leg ache is added  in follow up document.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Burning eyes; Leg aches; Fever; Fatigue; Headache; Can't lift my arm/swelling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning eyes), PAIN IN EXTREMITY (Leg aches), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache) in a  patient of an unknown age and gender 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 was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE IRRITATION (Burning eyes), PAIN IN EXTREMITY (Leg aches), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE SWELLING (Can't lift my arm/swelling). At the time of the report, EYE IRRITATION (Burning eyes), PAIN IN EXTREMITY (Leg aches), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE SWELLING (Can't lift my arm/swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Additional information received Added Events headache, fatigue, Vaccination site swelling and leg ache is added  in follow up document.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site bruising, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchy; Little red dots; 2.5 inch diameter soreness at the site; Soreness under the arm; Bruise at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at the site), VACCINATION SITE PRURITUS (Itchy), AXILLARY PAIN (Soreness under the arm), VACCINATION SITE PAIN (2.5 inch diameter soreness at the site) and VACCINATION SITE ERYTHEMA (Little red dots) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) for Nasal aspiration, MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at the site). On 19-Jan-2021, the patient experienced AXILLARY PAIN (Soreness under the arm). On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (2.5 inch diameter soreness at the site). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Little red dots). On 16-Jan-2021, VACCINATION SITE BRUISING (Bruise at the site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (2.5 inch diameter soreness at the site) and VACCINATION SITE ERYTHEMA (Little red dots) had not resolved and AXILLARY PAIN (Soreness under the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Extreme itching around shot site; swelling, moderate-not huge around shot site; Redness around the shot site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (swelling, moderate-not huge around shot site), VACCINATION SITE ERYTHEMA (Redness around the shot site) and VACCINATION SITE PRURITUS (Extreme itching around shot site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling, moderate-not huge around shot site), VACCINATION SITE ERYTHEMA (Redness around the shot site) and VACCINATION SITE PRURITUS (Extreme itching around shot site). In January 2021, PAIN IN EXTREMITY (Sore arm) was resolving. At the time of the report, VACCINATION SITE SWELLING (swelling, moderate-not huge around shot site), VACCINATION SITE ERYTHEMA (Redness around the shot site) and VACCINATION SITE PRURITUS (Extreme itching around shot site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No new information was updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Vaccination site started itching; Big red spot the size of tennis ball around the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Vaccination site started itching) and VACCINATION SITE ERYTHEMA (Big red spot the size of tennis ball around the vaccination site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site started itching) and VACCINATION SITE ERYTHEMA (Big red spot the size of tennis ball around the vaccination site). At the time of the report, VACCINATION SITE PRURITUS (Vaccination site started itching) and VACCINATION SITE ERYTHEMA (Big red spot the size of tennis ball around the vaccination site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: outcome of event changed from unknown to recovered .Reporter Email address was updated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Headache
Clinical narrative: Severe weakness; Nausea; Headache; Sore arm; Muscle pain; Joint pain; Fever; chills; Swollen lymph node in left arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no known allergies.  Concurrent medical conditions included Hypertension since 01-Jun-2012 and Depression since 01-Dec-2010. Concomitant products included CITALOPRAM from 01-Dec-2010 to an unknown date for Depression, IRBESARTAN from 01-Dec-2012 to an unknown date and HYDROCHLOROTHIAZIDE from 01-Dec-2012 to an unknown date for Hypertension.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021 at 1:30 PM, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm) and HEADACHE (Headache). On 20-Jan-2021 at 6:00 PM, the patient experienced ASTHENIA (Severe weakness) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) on 21-Jan-2021 for Fever, at a dose of UNK dosage form (2) at 8 PM; IBUPROFEN on 20-Jan-2021 for Headache, at a dose of 200 mg twice a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 21-Jan-2021 for Adverse event, at a dose of UNK dosage form. On 21-Jan-2021, ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm) and NAUSEA (Nausea) had resolved. On 22-Jan-2021, MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 101.8f (High) 101.8F and 100 (High) 100 at 4-5 when she took Ibuprofen tablets. On 20-Jan-2021, Heart rate: 130 bpm (High) 130 bpm. On 21-Jan-2021, Body temperature: 102.7f (High) 102.7F. On 21-Jan-2021, Heart rate: 110 bpm (High) 110 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm), NAUSEA (Nausea) and HEADACHE (Headache) to be possibly related.    It was reported that the adverse events were likely caused by mRNA-1273. There were no other potential causes.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Reporter details and concomitant drugs were added, outcome for the events with stop dates updated
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Lymphadenopathy, Myalgia, Nausea, Pain in extremity
Clinical narrative: Severe weakness; Nausea; Headache; Sore arm; Muscle pain; Joint pain; Fever; chills; Swollen lymph node in left arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no known allergies.  Concurrent medical conditions included Hypertension since 01-Jun-2012 and Depression since 01-Dec-2010. Concomitant products included CITALOPRAM from 01-Dec-2010 to an unknown date for Depression, IRBESARTAN from 01-Dec-2012 to an unknown date and HYDROCHLOROTHIAZIDE from 01-Dec-2012 to an unknown date for Hypertension.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021 at 1:30 PM, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm) and HEADACHE (Headache). On 20-Jan-2021 at 6:00 PM, the patient experienced ASTHENIA (Severe weakness) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) on 21-Jan-2021 for Fever, at a dose of UNK dosage form (2) at 8 PM; IBUPROFEN on 20-Jan-2021 for Headache, at a dose of 200 mg twice a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 21-Jan-2021 for Adverse event, at a dose of UNK dosage form. On 21-Jan-2021, ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm) and NAUSEA (Nausea) had resolved. On 22-Jan-2021, MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 101.8f (High) 101.8F and 100 (High) 100 at 4-5 when she took Ibuprofen tablets. On 20-Jan-2021, Heart rate: 130 bpm (High) 130 bpm. On 21-Jan-2021, Body temperature: 102.7f (High) 102.7F. On 21-Jan-2021, Heart rate: 110 bpm (High) 110 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm), NAUSEA (Nausea) and HEADACHE (Headache) to be possibly related.    It was reported that the adverse events were likely caused by mRNA-1273. There were no other potential causes.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Reporter details and concomitant drugs were added, outcome for the events with stop dates updated
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe weakness; Nausea; Headache; Sore arm; Muscle pain; Joint pain; Fever; chills; Swollen lymph node in left arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no known allergies.  Concurrent medical conditions included Hypertension since 01-Jun-2012 and Depression since 01-Dec-2010. Concomitant products included CITALOPRAM from 01-Dec-2010 to an unknown date for Depression, IRBESARTAN from 01-Dec-2012 to an unknown date and HYDROCHLOROTHIAZIDE from 01-Dec-2012 to an unknown date for Hypertension.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021 at 1:30 PM, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm) and HEADACHE (Headache). On 20-Jan-2021 at 6:00 PM, the patient experienced ASTHENIA (Severe weakness) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) on 21-Jan-2021 for Fever, at a dose of UNK dosage form (2) at 8 PM; IBUPROFEN on 20-Jan-2021 for Headache, at a dose of 200 mg twice a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 21-Jan-2021 for Adverse event, at a dose of UNK dosage form. On 21-Jan-2021, ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm) and NAUSEA (Nausea) had resolved. On 22-Jan-2021, MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 101.8f (High) 101.8F and 100 (High) 100 at 4-5 when she took Ibuprofen tablets. On 20-Jan-2021, Heart rate: 130 bpm (High) 130 bpm. On 21-Jan-2021, Body temperature: 102.7f (High) 102.7F. On 21-Jan-2021, Heart rate: 110 bpm (High) 110 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ASTHENIA (Severe weakness), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (chills), LYMPHADENOPATHY (Swollen lymph node in left arm), NAUSEA (Nausea) and HEADACHE (Headache) to be possibly related.    It was reported that the adverse events were likely caused by mRNA-1273. There were no other potential causes.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Reporter details and concomitant drugs were added, outcome for the events with stop dates updated
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling, Vaccination site discomfort, Vaccination site rash
Clinical narrative: rash/redness in left arm extending past injection site; reaction in her arm; discomfort just as the day after receiving the vaccine; Pain radiating from left shoulder, upper back to right shoulder; Swelling at left shoulder area near neck; Redness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction in her arm), VACCINATION SITE DISCOMFORT (discomfort just as the day after receiving the vaccine), PAIN (Pain radiating from left shoulder, upper back to right shoulder), SWELLING (Swelling at left shoulder area near neck) and ERYTHEMA (Redness in arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for Blood pressure, CENTRUM SILVER [ASCORBIC ACID;BIOTIN;BORON;CALCIUM;CALCIUM PANTOTHENATE;CHLORINE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCH for Supplementation therapy, LEVOTHYROXINE for Thyroidectomy partial, CALCIUM (ALGAE CALCIUM) and MONASCUS PURPUREUS (RED YEAST RICE) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE REACTION (reaction in her arm), VACCINATION SITE DISCOMFORT (discomfort just as the day after receiving the vaccine), PAIN (Pain radiating from left shoulder, upper back to right shoulder), SWELLING (Swelling at left shoulder area near neck) and ERYTHEMA (Redness in arm). On an unknown date, the patient experienced VACCINATION SITE RASH (rash/redness in left arm extending past injection site). At the time of the report, VACCINATION SITE REACTION (reaction in her arm), VACCINATION SITE DISCOMFORT (discomfort just as the day after receiving the vaccine), PAIN (Pain radiating from left shoulder, upper back to right shoulder), ERYTHEMA (Redness in arm) and VACCINATION SITE RASH (rash/redness in left arm extending past injection site) had resolved and SWELLING (Swelling at left shoulder area near neck) had not resolved. Not Provided          Concomitant medications Algal cal plus indicated for Bone strength & Red yeast rice with Coq indicated for cardio health. It was reported that patient was advised to take Tylenol   This case was linked to MOD-2021-245531 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Updated patient address and email ID On 23-Jun-2021: F/U- 2 : Patient demographics, medical history, dose 2 details and concomitant medication list were added. And adverse event details and outcome are updated.