chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Cardiac disorder, Chills, Fatigue
Clinical narrative: I am having tachycardia; Feel anxious; I have unexplained heart problems; I always feel like my body's sympathetic nervous system has gone on over drive; Body pain, aches; Not able to do much; That night I got sick; With a temperature of 103 degrees Fahrenheit; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (That night I got sick), TACHYCARDIA (I am having tachycardia), ANXIETY (Feel anxious), CARDIAC DISORDER (I have unexplained heart problems) and NERVOUS SYSTEM DISORDER (I always feel like my body's sympathetic nervous system has gone on over drive) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cardiac disorder NOS.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ILLNESS (That night I got sick), PYREXIA (With a temperature of 103 degrees Fahrenheit) and CHILLS (Chills). On 28-Apr-2021, the patient experienced MYALGIA (Body pain, aches) and FATIGUE (Not able to do much). On 02-Jul-2021, the patient experienced TACHYCARDIA (I am having tachycardia), ANXIETY (Feel anxious), CARDIAC DISORDER (I have unexplained heart problems) and NERVOUS SYSTEM DISORDER (I always feel like my body's sympathetic nervous system has gone on over drive). On 05-May-2021, ILLNESS (That night I got sick), MYALGIA (Body pain, aches), PYREXIA (With a temperature of 103 degrees Fahrenheit), CHILLS (Chills) and FATIGUE (Not able to do much) had resolved. At the time of the report, TACHYCARDIA (I am having tachycardia), ANXIETY (Feel anxious), CARDIAC DISORDER (I have unexplained heart problems) and NERVOUS SYSTEM DISORDER (I always feel like my body's sympathetic nervous system has gone on over drive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 103 (High) 103 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included  Beta Blockers, Anxiety Medications and Cholesterol Medications.  Treatment information was not provided.   This case was linked to MOD-2021-245625 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Nervous system disorder, Pyrexia, Tachycardia
Clinical narrative: I am having tachycardia; Feel anxious; I have unexplained heart problems; I always feel like my body's sympathetic nervous system has gone on over drive; Body pain, aches; Not able to do much; That night I got sick; With a temperature of 103 degrees Fahrenheit; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (That night I got sick), TACHYCARDIA (I am having tachycardia), ANXIETY (Feel anxious), CARDIAC DISORDER (I have unexplained heart problems) and NERVOUS SYSTEM DISORDER (I always feel like my body's sympathetic nervous system has gone on over drive) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cardiac disorder NOS.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced ILLNESS (That night I got sick), PYREXIA (With a temperature of 103 degrees Fahrenheit) and CHILLS (Chills). On 28-Apr-2021, the patient experienced MYALGIA (Body pain, aches) and FATIGUE (Not able to do much). On 02-Jul-2021, the patient experienced TACHYCARDIA (I am having tachycardia), ANXIETY (Feel anxious), CARDIAC DISORDER (I have unexplained heart problems) and NERVOUS SYSTEM DISORDER (I always feel like my body's sympathetic nervous system has gone on over drive). On 05-May-2021, ILLNESS (That night I got sick), MYALGIA (Body pain, aches), PYREXIA (With a temperature of 103 degrees Fahrenheit), CHILLS (Chills) and FATIGUE (Not able to do much) had resolved. At the time of the report, TACHYCARDIA (I am having tachycardia), ANXIETY (Feel anxious), CARDIAC DISORDER (I have unexplained heart problems) and NERVOUS SYSTEM DISORDER (I always feel like my body's sympathetic nervous system has gone on over drive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 103 (High) 103 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included  Beta Blockers, Anxiety Medications and Cholesterol Medications.  Treatment information was not provided.   This case was linked to MOD-2021-245625 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: she has constant pain on that arm; her left arm swelled up and turned red for about a week; her left arm swelled up and turned red for about a week; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (her left arm swelled up and turned red for about a week), ERYTHEMA (her left arm swelled up and turned red for about a week) and PAIN IN EXTREMITY (she has constant pain on that arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. T022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (her left arm swelled up and turned red for about a week) and ERYTHEMA (her left arm swelled up and turned red for about a week). an unknown date, the patient experienced PAIN IN EXTREMITY (she has constant pain on that arm). The patient was treated with NAPROXEN SODIUM (ALEVE) for Pain in arm, at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (her left arm swelled up and turned red for about a week) and ERYTHEMA (her left arm swelled up and turned red for about a week) had resolved and PAIN IN EXTREMITY (she has constant pain on that arm) had not resolved.            Concomitant medications included unspecified high blood pressure and high cholesterol pills. Patient went to see chiropractor and therapists but they did not help her in relieving the pain in the arm.   This case was linked to MOD-2021-245624 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Balance disorder, Dizziness, Ear discomfort, Feeling abnormal
Clinical narrative: Physician thinks it's anxiety issues; Muscles are very achy in neck and upper back; Feel really awful/Feels like he has been run over; Dizziness; Head Pressure; Ear Pressure / left year pops; Feels off balance; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel really awful/Feels like he has been run over), DIZZINESS (Dizziness), HEAD DISCOMFORT (Head Pressure), EAR DISCOMFORT (Ear Pressure / left year pops) and BALANCE DISORDER (Feels off balance) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported. .    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced FEELING ABNORMAL (Feel really awful/Feels like he has been run over), DIZZINESS (Dizziness), HEAD DISCOMFORT (Head Pressure), EAR DISCOMFORT (Ear Pressure / left year pops), BALANCE DISORDER (Feels off balance) and MYALGIA (Muscles are very achy in neck and upper back). On an unknown date, the patient experienced ANXIETY (Physician thinks it's anxiety issues). At the time of the report, FEELING ABNORMAL (Feel really awful/Feels like he has been run over), DIZZINESS (Dizziness), HEAD DISCOMFORT (Head Pressure), EAR DISCOMFORT (Ear Pressure / left year pops), BALANCE DISORDER (Feels off balance), ANXIETY (Physician thinks it's anxiety issues) and MYALGIA (Muscles are very achy in neck and upper back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown. Treatment information was unknown. No lab data has been provided by the reporter.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Myalgia
Clinical narrative: Physician thinks it's anxiety issues; Muscles are very achy in neck and upper back; Feel really awful/Feels like he has been run over; Dizziness; Head Pressure; Ear Pressure / left year pops; Feels off balance; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel really awful/Feels like he has been run over), DIZZINESS (Dizziness), HEAD DISCOMFORT (Head Pressure), EAR DISCOMFORT (Ear Pressure / left year pops) and BALANCE DISORDER (Feels off balance) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported. .    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced FEELING ABNORMAL (Feel really awful/Feels like he has been run over), DIZZINESS (Dizziness), HEAD DISCOMFORT (Head Pressure), EAR DISCOMFORT (Ear Pressure / left year pops), BALANCE DISORDER (Feels off balance) and MYALGIA (Muscles are very achy in neck and upper back). On an unknown date, the patient experienced ANXIETY (Physician thinks it's anxiety issues). At the time of the report, FEELING ABNORMAL (Feel really awful/Feels like he has been run over), DIZZINESS (Dizziness), HEAD DISCOMFORT (Head Pressure), EAR DISCOMFORT (Ear Pressure / left year pops), BALANCE DISORDER (Feels off balance), ANXIETY (Physician thinks it's anxiety issues) and MYALGIA (Muscles are very achy in neck and upper back) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown. Treatment information was unknown. No lab data has been provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vial was opened, then punctured and was returned  back to the refrigerator for 2 weeks and was then used to administer to the patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was opened, then punctured and was returned  back to the refrigerator for 2 weeks and was then used to administer to the patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was opened, then punctured and was returned  back to the refrigerator for 2 weeks and was then used to administer to the patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was opened, then punctured and was returned  back to the refrigerator for 2 weeks and was then used to administer to the patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  No treatment of events was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: After 3-4 days of the first shot of Moderna, I feel chest pain  I have visited the provider last Saturday and this Monday. They asked me to report the side effects to you; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (After 3-4 days of the first shot of Moderna, I feel chest pain  I have visited the provider last Saturday and this Monday. They asked me to report the side effects to you) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (After 3-4 days of the first shot of Moderna, I feel chest pain  I have visited the provider last Saturday and this Monday. They asked me to report the side effects to you). At the time of the report, CHEST PAIN (After 3-4 days of the first shot of Moderna, I feel chest pain  I have visited the provider last Saturday and this Monday. They asked me to report the side effects to you) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported. No lab data has been provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not reported.  This case is a cluster case.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed 2nd vaccine window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd vaccine window) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported. .     On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2nd vaccine window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2nd vaccine window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided. No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: TCR: nonsafety info
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Hypoaesthesia, Joint swelling, Pain in extremity
Clinical narrative: hands got swollen; Sometimes she feels a little numbness sometimes she doesn't; joints got swollen; After her fever broke, she noticed she was covered in hives; sore arm, but it was worse than for the first one; fever of 101°F; felt very very cold; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands got swollen), HYPOAESTHESIA (Sometimes she feels a little numbness sometimes she doesn't), JOINT SWELLING (joints got swollen), URTICARIA (After her fever broke, she noticed she was covered in hives) and FEELING COLD (felt very very cold) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) 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 SIMVASTATIN for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FEELING COLD (felt very very cold) and PYREXIA (fever of 101°F). On an unknown date, the patient experienced PERIPHERAL SWELLING (hands got swollen), HYPOAESTHESIA (Sometimes she feels a little numbness sometimes she doesn't), JOINT SWELLING (joints got swollen), URTICARIA (After her fever broke, she noticed she was covered in hives) and PAIN IN EXTREMITY (sore arm, but it was worse than for the first one). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 22-Apr-2021 for Fever, at an unspecified dose and frequency; PREDNISONE (oral) ongoing since an unknown date for Hives, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Hives, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (hands got swollen), HYPOAESTHESIA (Sometimes she feels a little numbness sometimes she doesn't), JOINT SWELLING (joints got swollen), URTICARIA (After her fever broke, she noticed she was covered in hives), FEELING COLD (felt very very cold) and PAIN IN EXTREMITY (sore arm, but it was worse than for the first one) outcome was unknown and PYREXIA (fever of 101°F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 101°f (High) 101°F.         This case was linked to MOD-2021-245779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: follow up received and contains no new information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Urticaria
Clinical narrative: hands got swollen; Sometimes she feels a little numbness sometimes she doesn't; joints got swollen; After her fever broke, she noticed she was covered in hives; sore arm, but it was worse than for the first one; fever of 101°F; felt very very cold; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands got swollen), HYPOAESTHESIA (Sometimes she feels a little numbness sometimes she doesn't), JOINT SWELLING (joints got swollen), URTICARIA (After her fever broke, she noticed she was covered in hives) and FEELING COLD (felt very very cold) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) 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 SIMVASTATIN for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FEELING COLD (felt very very cold) and PYREXIA (fever of 101°F). On an unknown date, the patient experienced PERIPHERAL SWELLING (hands got swollen), HYPOAESTHESIA (Sometimes she feels a little numbness sometimes she doesn't), JOINT SWELLING (joints got swollen), URTICARIA (After her fever broke, she noticed she was covered in hives) and PAIN IN EXTREMITY (sore arm, but it was worse than for the first one). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 22-Apr-2021 for Fever, at an unspecified dose and frequency; PREDNISONE (oral) ongoing since an unknown date for Hives, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Hives, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (hands got swollen), HYPOAESTHESIA (Sometimes she feels a little numbness sometimes she doesn't), JOINT SWELLING (joints got swollen), URTICARIA (After her fever broke, she noticed she was covered in hives), FEELING COLD (felt very very cold) and PAIN IN EXTREMITY (sore arm, but it was worse than for the first one) outcome was unknown and PYREXIA (fever of 101°F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 101°f (High) 101°F.         This case was linked to MOD-2021-245779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: follow up received and contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Vaccination complication
Clinical narrative: Unspecific adverse event; Chest Pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain) and VACCINATION COMPLICATION (Unspecific adverse event) 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.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced CHEST PAIN (Chest Pain). On 02-Jul-2021, the patient experienced VACCINATION COMPLICATION (Unspecific adverse event). At the time of the report, CHEST PAIN (Chest Pain) and VACCINATION COMPLICATION (Unspecific adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided  No treatment medication was reported
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Hypoaesthesia
Clinical narrative: numbness in fingertips, both hands,numbness in her hand, fingers tips, down the side of her hand; having trouble picking things up with her hands; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in fingertips, both hands,numbness in her hand, fingers tips, down the side of her hand) and GRIP STRENGTH DECREASED (having trouble picking things up with her hands) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 036A21A) for COVID-19 vaccination.     No medical history were reported. .    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in fingertips, both hands,numbness in her hand, fingers tips, down the side of her hand) and GRIP STRENGTH DECREASED (having trouble picking things up with her hands). At the time of the report, HYPOAESTHESIA (numbness in fingertips, both hands,numbness in her hand, fingers tips, down the side of her hand) and GRIP STRENGTH DECREASED (having trouble picking things up with her hands) outcome was unknown.            No Concomitant medication was reported. No treatment medication was reported. No lab data has been provided by the reporter.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysgeusia
Clinical narrative: Strong metallic taste in mouth; weakness and low energy; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Strong metallic taste in mouth) and ASTHENIA (weakness and low energy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B218) for COVID-19 vaccination.     The patient's past medical history included Nerve compression (HERNIATED  PINCH NERVE ON NECK), Intervertebral disc bulging and Patellofemoral pain syndrome. Concomitant products included VITAMIN D3, BIOTIN, VITAMIN C [ASCORBIC ACID] and CHONDROITIN SULFATE, COLLAGEN, GLUCOSAMINE (UC II) for an unknown indication.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DYSGEUSIA (Strong metallic taste in mouth) and ASTHENIA (weakness and low energy). The patient was treated with VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (Strong metallic taste in mouth) and ASTHENIA (weakness and low energy) had not resolved. Not Provided          Patient lab data SARS-COV-2 AB test and the results came back at >2500.0   This case was linked to MOD-2021-214839 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received does not contain any new information
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Missed second dose; I got the vaccine the first week of may but I got COVID next week of May; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) and SUSPECTED COVID-19 (I got the vaccine the first week of may but I got COVID next week of May) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     The patient's past medical history included Accident (Have had left knee operated for 12 days and torn anterior cruciate ligament and meniscus) on 29-Jun-2021.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced SUSPECTED COVID-19 (I got the vaccine the first week of may but I got COVID next week of May). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved and SUSPECTED COVID-19 (I got the vaccine the first week of may but I got COVID next week of May) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, SARS-CoV-2 test: positive (Positive) Positive..         No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Patient Details and Medical history provided On 25-Jul-2021: Translation document received containing No new nformation On 30-Jul-2021: follow up received contain no new information
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site pain, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Injection site warm to touch; Injection site welted up; Injection site sore; Rash/rash got worse; Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), VACCINATION SITE WARMTH (Injection site warm to touch), RASH (Rash/rash got worse), VACCINATION SITE URTICARIA (Injection site welted up) and VACCINATION SITE PAIN (Injection site sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2021, the patient experienced URTICARIA (Hives) and RASH (Rash/rash got worse). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch), VACCINATION SITE URTICARIA (Injection site welted up) and VACCINATION SITE PAIN (Injection site sore). At the time of the report, URTICARIA (Hives), VACCINATION SITE WARMTH (Injection site warm to touch), RASH (Rash/rash got worse), VACCINATION SITE URTICARIA (Injection site welted up) and VACCINATION SITE PAIN (Injection site sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported. No treatment medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: loss of pigment in the skin; This spontaneous case was reported by a consumer and describes the occurrence of VITILIGO (loss of pigment in the skin) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CICLOSPORIN (RESTASIS) for Eye abnormality NOS.    On 18-Mar-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 VITILIGO (loss of pigment in the skin). At the time of the report, VITILIGO (loss of pigment in the skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No lab data has been provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm after vaccination). At the time of the report, VACCINATION SITE PAIN (Sore arm after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  No treatment medication was reported.  Patient experienced sore arm that lasted for a day, after a week patient's sore arm became more sore that she can barely raise the arm over her head.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Crying, Depressed mood, Feeling abnormal
Clinical narrative: Experiencing anxiety which is not normal for her, anxiety that has been debilitating; Crying/ sobbing; Sadness; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Experiencing anxiety which is not normal for her, anxiety that has been debilitating), CRYING (Crying/ sobbing), DEPRESSED MOOD (Sadness) and FEELING ABNORMAL (Brain fog) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced ANXIETY (Experiencing anxiety which is not normal for her, anxiety that has been debilitating), CRYING (Crying/ sobbing), DEPRESSED MOOD (Sadness) and FEELING ABNORMAL (Brain fog). At the time of the report, ANXIETY (Experiencing anxiety which is not normal for her, anxiety that has been debilitating), CRYING (Crying/ sobbing), DEPRESSED MOOD (Sadness) and FEELING ABNORMAL (Brain fog) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: nodes on my left hand side of the arm are swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (nodes on my left hand side of the arm are swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Jun-2021, the patient experienced LYMPHADENOPATHY (nodes on my left hand side of the arm are swollen). At the time of the report, LYMPHADENOPATHY (nodes on my left hand side of the arm are swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 contains non significant information. Contact details updated for the reporter and the event verbatim term was updated from lymph node on my right hand side to lymph nodes on my left hand side.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I missed my 2nd shot. It's been months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I missed my 2nd shot. It's been months) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PRODUCT DOSE OMISSION ISSUE (I missed my 2nd shot. It's been months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I missed my 2nd shot. It's been months) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 17 year old patient was administered the First dose of the Moderna Covid 19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was administered the First dose of the Moderna Covid 19 Vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No medical history were reported. .     On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was administered the First dose of the Moderna Covid 19 Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was administered the First dose of the Moderna Covid 19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not provided.  Treatment information not provided. No lab data has been provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose was 2 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose was 2 months ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PRODUCT DOSE OMISSION ISSUE (1st dose was 2 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose was 2 months ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Unable to get the second/It is now 7 weeks since first shot; Patient received the 1st dose 05May2021 still has not received the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get the second/It is now 7 weeks since first shot) and PRODUCT DOSE OMISSION ISSUE (Patient received the 1st dose 05May2021 still has not received the 2nd dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Unable to get the second/It is now 7 weeks since first shot) and PRODUCT DOSE OMISSION ISSUE (Patient received the 1st dose 05May2021 still has not received the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Unable to get the second/It is now 7 weeks since first shot) and PRODUCT DOSE OMISSION ISSUE (Patient received the 1st dose 05May2021 still has not received the 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received contains significant information. The primary reporter details has been updated. The patient demographics ( age, gender ) has been added. The dose 1 start date has been added. The event has been updated.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Is this vaccine safe to receive while breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Is this vaccine safe to receive while breastfeeding) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Is this vaccine safe to receive while breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (Is this vaccine safe to receive while breastfeeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: diagnosed with COVID-19; never received the second dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (diagnosed with COVID-19) and PRODUCT DOSE OMISSION ISSUE (never received the second dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced PRODUCT DOSE OMISSION ISSUE (never received the second dose). On an unknown date, the patient experienced COVID-19 (diagnosed with COVID-19). At the time of the report, COVID-19 (diagnosed with COVID-19) and PRODUCT DOSE OMISSION ISSUE (never received the second 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.   No concomitant medications were reported.  No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever; Body aches; Arm hurt; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE SWELLING (Arm was swollen), PYREXIA (Fever) and MYALGIA (Body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt) and VACCINATION SITE SWELLING (Arm was swollen). On 27-Mar-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE PAIN (Arm hurt), VACCINATION SITE SWELLING (Arm was swollen), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No treatment information was provided.      This case was linked to MOD-2021-245670 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Applied more than 1 dose to both patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Applied more than 1 dose to both patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced ACCIDENTAL OVERDOSE (Applied more than 1 dose to both patients). At the time of the report, ACCIDENTAL OVERDOSE (Applied more than 1 dose to both patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. The reporter stated that she used a wrong size syringe to apply the vaccine. No treatment information was provided.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Product expiration date issue
Clinical narrative: Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT EXPIRATION DATE ISSUE (Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced PRODUCT EXPIRATION DATE ISSUE (Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021). On 18-May-2021, PRODUCT EXPIRATION DATE ISSUE (Vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: event was updated
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid Positive after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid Positive after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 COVID-19 (Covid Positive after vaccination). At the time of the report, COVID-19 (Covid Positive after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Headache, Myalgia, Pyrexia
Clinical narrative: had at least 3 nosebleeds in the last month out of nowhere; rash on the upper neck and around her chest and around her blossom; head aches; fever; muscle aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (had at least 3 nosebleeds in the last month out of nowhere), RASH (rash on the upper neck and around her chest and around her blossom), HEADACHE (head aches), PYREXIA (fever) and MYALGIA (muscle aches) in a 37-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.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (had at least 3 nosebleeds in the last month out of nowhere), RASH (rash on the upper neck and around her chest and around her blossom), HEADACHE (head aches), PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL HEADACHE & MIGRAINE) for Pain head, at a dose of 1 dosage form. At the time of the report, EPISTAXIS (had at least 3 nosebleeds in the last month out of nowhere), RASH (rash on the upper neck and around her chest and around her blossom), HEADACHE (head aches), PYREXIA (fever), MYALGIA (muscle aches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: decreased (Low) white blood cells have taken a big decline.         No concomitant medications were reported.  Treatment medication included Steroid cream for the rash.   Reporter did not allow further contact