chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Head discomfort, Headache
Clinical narrative: This spontaneous case reported by a consume, describes the occurrence of dry eye (eyes very dry/severe/even worse), headache (like a headache but it's not) and head discomfort (pressure) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039K20A) for COVID-19 vaccination. Concurrent medical conditions included dry eye. On Mar 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced  dry eye (eyes very dry/severe/even worse), headache (like a headache but it's not) and head discomfort (pressure). The patient treated with physical therapy (compresses) for dry eye. At the time of the report, dry eye (eyes very dry/severe/even worse), headache (like a headache but it's not) and head discomfort (pressure) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Patient reported a hard time opening eyes. It's worse during the night; had been using compresses and eye drops as treatment. The unspecified treatment provided by the physician was ineffective too. No concomitant mediation reported. The reporter did not provide any causality assessments.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 11 days between both doses; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (11 days between both doses) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (11 days between both doses). On 19-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (11 days between both doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Arm is sore; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache) and NAUSEA (Nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-1021, the patient experienced NAUSEA (Nausea). On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm is sore) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided          Concomitant medications were not reported.  No treatment details were provided    This case was linked to MOD-2021-079975 (E2B Linked Report). This case was linked to MOD-2021-079975 (Patient Link).; Sender's Comments:  MOD-2021-079975:First dose case
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Mobility decreased, Osteoarthritis, Pain
Clinical narrative: "I was told I have arthritis, osteoarthritis and I never had all that before."; "I was told I have arthritis, osteoarthritis and I never had all that before."; " I had so much pain in my hips and groins"; "shoulder pain."; "I could barely walk."; "aches and pains"; "I still have a hurting feeling in the left arm"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN ("aches and pains"), PAIN IN EXTREMITY ("I still have a hurting feeling in the left arm"), ARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), OSTEOARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before.") and MOBILITY DECREASED ("I could barely walk.") in a 69-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.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN ("aches and pains"), PAIN IN EXTREMITY ("I still have a hurting feeling in the left arm") and MOBILITY DECREASED ("I could barely walk."). On an unknown date, the patient experienced ARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), OSTEOARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), PAIN (" I had so much pain in my hips and groins") and ARTHRALGIA ("shoulder pain."). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN ("aches and pains"), PAIN IN EXTREMITY ("I still have a hurting feeling in the left arm"), ARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), OSTEOARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), MOBILITY DECREASED ("I could barely walk."), PAIN (" I had so much pain in my hips and groins") and ARTHRALGIA ("shoulder pain.") outcome was unknown. Not Provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: "I was told I have arthritis, osteoarthritis and I never had all that before."; "I was told I have arthritis, osteoarthritis and I never had all that before."; " I had so much pain in my hips and groins"; "shoulder pain."; "I could barely walk."; "aches and pains"; "I still have a hurting feeling in the left arm"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN ("aches and pains"), PAIN IN EXTREMITY ("I still have a hurting feeling in the left arm"), ARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), OSTEOARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before.") and MOBILITY DECREASED ("I could barely walk.") in a 69-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.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN ("aches and pains"), PAIN IN EXTREMITY ("I still have a hurting feeling in the left arm") and MOBILITY DECREASED ("I could barely walk."). On an unknown date, the patient experienced ARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), OSTEOARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), PAIN (" I had so much pain in my hips and groins") and ARTHRALGIA ("shoulder pain."). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN ("aches and pains"), PAIN IN EXTREMITY ("I still have a hurting feeling in the left arm"), ARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), OSTEOARTHRITIS ("I was told I have arthritis, osteoarthritis and I never had all that before."), MOBILITY DECREASED ("I could barely walk."), PAIN (" I had so much pain in my hips and groins") and ARTHRALGIA ("shoulder pain.") outcome was unknown. Not Provided
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old received the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine). On 24-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old received the Moderna COVID 19 vaccine) 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.   Concomitant product use was not provided. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Medical device pain, Pain, Pain in extremity
Clinical narrative: She had to go to the dentist to have her cap replacement; Aches and pain; Arm is very sore; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of MEDICAL DEVICE PAIN (She had to go to the dentist to have her cap replacement), PAIN (Aches and pain), PAIN IN EXTREMITY (Arm is very sore) and FATIGUE (Felt tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A. and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-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 MEDICAL DEVICE PAIN (She had to go to the dentist to have her cap replacement), PAIN (Aches and pain), PAIN IN EXTREMITY (Arm is very sore) and FATIGUE (Felt tired). At the time of the report, MEDICAL DEVICE PAIN (She had to go to the dentist to have her cap replacement), PAIN (Aches and pain), PAIN IN EXTREMITY (Arm is very sore) and FATIGUE (Felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  It was reported that the patient was treated with numb shot to relieve the pain.  Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis bacterial
Clinical narrative: Bacterial bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS BACTERIAL (Bacterial bronchitis) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS BACTERIAL (Bacterial bronchitis). At the time of the report, BRONCHITIS BACTERIAL (Bacterial bronchitis) had resolved.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-080097 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant followup received on 26-May-2021. Event outcome details updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-080097:Brother case
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown. Not Provided      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 product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to US-MODERNATX, INC.-MOD-2021-079996 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079996:dose 2
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Hyperhidrosis, Peripheral swelling, Vaccination site erythema
Clinical narrative: Sweating out of blue; Completely run down; Swollen arm; Injection site really red; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating out of blue), DEPRESSED MOOD (Completely run down), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Injection site really red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-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) 1 dosage form. On 16-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating out of blue), DEPRESSED MOOD (Completely run down), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Injection site really red). At the time of the report, HYPERHIDROSIS (Sweating out of blue), DEPRESSED MOOD (Completely run down), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Injection site really red) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral swelling
Clinical narrative: Swollen to the size the tennis ball; Feels heavy and weighted down; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen to the size the tennis ball) and LIMB DISCOMFORT (Feels heavy and weighted down) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen to the size the tennis ball) and LIMB DISCOMFORT (Feels heavy and weighted down). At the time of the report, PERIPHERAL SWELLING (Swollen to the size the tennis ball) and LIMB DISCOMFORT (Feels heavy and weighted down) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   It was reported that patient was supposed to take her second dose on 08-May-2021 but she thought of not getting her second shot.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Fatigue
Clinical narrative: anosmia; Ageusia; covid-19; Slept most of the day; Extremely Tired; Fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANOSMIA (anosmia), AGEUSIA (Ageusia), COVID-19 (covid-19), SOMNOLENCE (Slept most of the day) and FATIGUE (Extremely Tired) 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 No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 31-Mar-2021, the patient experienced SOMNOLENCE (Slept most of the day), FATIGUE (Extremely Tired), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced ANOSMIA (anosmia), AGEUSIA (Ageusia) and COVID-19 (covid-19). On 01-Apr-2021, SOMNOLENCE (Slept most of the day), FATIGUE (Extremely Tired), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, ANOSMIA (anosmia), AGEUSIA (Ageusia) and COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment med: Tylenol Patient was scheduled for the second dose of the Moderna COVID-19 Vaccine on 28Apr2021. Patient was extremely tired and experienced fever and chills and slept most of the dayThen couple of days later, patient lost sense of smell and taste and went for COVID test. patient tested positive.she started feeling fine.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: anosmia; Ageusia; covid-19; Slept most of the day; Extremely Tired; Fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANOSMIA (anosmia), AGEUSIA (Ageusia), COVID-19 (covid-19), SOMNOLENCE (Slept most of the day) and FATIGUE (Extremely Tired) 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 No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 31-Mar-2021, the patient experienced SOMNOLENCE (Slept most of the day), FATIGUE (Extremely Tired), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced ANOSMIA (anosmia), AGEUSIA (Ageusia) and COVID-19 (covid-19). On 01-Apr-2021, SOMNOLENCE (Slept most of the day), FATIGUE (Extremely Tired), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, ANOSMIA (anosmia), AGEUSIA (Ageusia) and COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment med: Tylenol Patient was scheduled for the second dose of the Moderna COVID-19 Vaccine on 28Apr2021. Patient was extremely tired and experienced fever and chills and slept most of the dayThen couple of days later, patient lost sense of smell and taste and went for COVID test. patient tested positive.she started feeling fine.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Headache, Migraine, Myalgia
Clinical narrative: Stomach really hurts; Severe migraine; Vomiting /She wants to throw up; Body aches; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach really hurts), MIGRAINE (Severe migraine), PYREXIA (Fever), VOMITING (Vomiting /She wants to throw up) and MYALGIA (Body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and HEADACHE (Headache). On 19-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach really hurts), MIGRAINE (Severe migraine) and VOMITING (Vomiting /She wants to throw up). At the time of the report, ABDOMINAL PAIN UPPER (Stomach really hurts), MIGRAINE (Severe migraine), PYREXIA (Fever), VOMITING (Vomiting /She wants to throw up), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 102.2 (High) 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 provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Stomach really hurts; Severe migraine; Vomiting /She wants to throw up; Body aches; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach really hurts), MIGRAINE (Severe migraine), PYREXIA (Fever), VOMITING (Vomiting /She wants to throw up) and MYALGIA (Body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and HEADACHE (Headache). On 19-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach really hurts), MIGRAINE (Severe migraine) and VOMITING (Vomiting /She wants to throw up). At the time of the report, ABDOMINAL PAIN UPPER (Stomach really hurts), MIGRAINE (Severe migraine), PYREXIA (Fever), VOMITING (Vomiting /She wants to throw up), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 102.2 (High) 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 provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Hypersomnia, Hypoacusis, Muscular weakness, Pyrexia
Clinical narrative: I can't get my hearing back; There's a continuous loud ringing in both ears; Got an upset stomach; My hearing started getting weak, like turning volume down, then it started ringing; Muscle weakness; I slept for over 30hrs straight; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (My hearing started getting weak, like turning volume down, then it started ringing), MUSCULAR WEAKNESS (Muscle weakness), HYPERSOMNIA (I slept for over 30hrs straight), ABDOMINAL DISCOMFORT (Got an upset stomach) and HYPOACUSIS (I can't get my hearing back) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Allergy: Penicillin), Allergy to chemicals (Allergy: Sodium pentothal), Blood pressure and Hemochromatosis. Concomitant products included CARVEDILOL and LOSARTAN for Blood pressure, SIMVASTATIN for Cholesterol, METFORMIN for Diabetes, DOXAZOSIN for Prostate infection.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness). 30-Mar-2021, the patient experienced HYPERSOMNIA (I slept for over 30hrs straight) and PYREXIA (Fever). On 30-Mar-2021 at 2:00 PM, the patient experienced HYPOACUSIS (My hearing started getting weak, like turning volume down, then it started ringing). On 31-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Got an upset stomach). On 19-Apr-2021, the patient experienced HYPOACUSIS (I can't get my hearing back) and TINNITUS (There's a continuous loud ringing in both ears). At the time of the report, HYPOACUSIS (My hearing started getting weak, like turning volume down, then it started ringing), HYPOACUSIS (I can't get my hearing back) and TINNITUS (There's a continuous loud ringing in both ears) had not resolved and MUSCULAR WEAKNESS (Muscle weakness), HYPERSOMNIA (I slept for over 30hrs straight), ABDOMINAL DISCOMFORT (Got an upset stomach) and PYREXIA (Fever) outcome was unknown.            Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-079991 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up was received on 22-Jun-2021. Patient details like height, weight, race, ethnicity were updated. Patient's allergic and current conditions were updated. Concomitant medication details were updated. Events outcome was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079991:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I can't get my hearing back; There's a continuous loud ringing in both ears; Got an upset stomach; My hearing started getting weak, like turning volume down, then it started ringing; Muscle weakness; I slept for over 30hrs straight; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (My hearing started getting weak, like turning volume down, then it started ringing), MUSCULAR WEAKNESS (Muscle weakness), HYPERSOMNIA (I slept for over 30hrs straight), ABDOMINAL DISCOMFORT (Got an upset stomach) and HYPOACUSIS (I can't get my hearing back) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Allergy: Penicillin), Allergy to chemicals (Allergy: Sodium pentothal), Blood pressure and Hemochromatosis. Concomitant products included CARVEDILOL and LOSARTAN for Blood pressure, SIMVASTATIN for Cholesterol, METFORMIN for Diabetes, DOXAZOSIN for Prostate infection.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness). 30-Mar-2021, the patient experienced HYPERSOMNIA (I slept for over 30hrs straight) and PYREXIA (Fever). On 30-Mar-2021 at 2:00 PM, the patient experienced HYPOACUSIS (My hearing started getting weak, like turning volume down, then it started ringing). On 31-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Got an upset stomach). On 19-Apr-2021, the patient experienced HYPOACUSIS (I can't get my hearing back) and TINNITUS (There's a continuous loud ringing in both ears). At the time of the report, HYPOACUSIS (My hearing started getting weak, like turning volume down, then it started ringing), HYPOACUSIS (I can't get my hearing back) and TINNITUS (There's a continuous loud ringing in both ears) had not resolved and MUSCULAR WEAKNESS (Muscle weakness), HYPERSOMNIA (I slept for over 30hrs straight), ABDOMINAL DISCOMFORT (Got an upset stomach) and PYREXIA (Fever) outcome was unknown.            Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-079991 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up was received on 22-Jun-2021. Patient details like height, weight, race, ethnicity were updated. Patient's allergic and current conditions were updated. Concomitant medication details were updated. Events outcome was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079991:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itchiness of the arm; redness of the arm; rash that has not completely gone away after taking the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness of the arm), VACCINATION SITE ERYTHEMA (redness of the arm) and RASH (rash that has not completely gone away after taking the first dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (The patient cant use her right arm.). Concurrent medical conditions included Blood pressure.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced RASH (rash that has not completely gone away after taking the first dose). On 10-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness of the arm) and VACCINATION SITE ERYTHEMA (redness of the arm). At the time of the report, VACCINATION SITE PRURITUS (itchiness of the arm) and VACCINATION SITE ERYTHEMA (redness of the arm) outcome was unknown and RASH (rash that has not completely gone away after taking the first dose) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure and water pills.  Treatment included  Benadryl, cortisone, antibiotics and ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Significant Follow up appended: Patient contact details, vaccination date, medical history, new event and treatment medications were updated.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Skin odour abnormal
Clinical narrative: Has been smelling a strong chemical smell from his body which he has never smelled before and which he cannot get rid of and which is driving him crazy; Sometimes he gets sweaty when doing something; This spontaneous case was reported by a consumer and describes the occurrence of SKIN ODOUR ABNORMAL (Has been smelling a strong chemical smell from his body which he has never smelled before and which he cannot get rid of and which is driving him crazy) and HYPERHIDROSIS (Sometimes he gets sweaty when doing something) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 0114214 or 011A21A or 011A214) for COVID-19 vaccination.     The patient's past medical history included Urinary tract infection, Pain (Severe) and Constipation. Concomitant products included MILK OF MAGNESIA for Constipation, HYDROCODONE for Pain, LEVOFLOXACIN (LEVAQUIN) for UTI, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced SKIN ODOUR ABNORMAL (Has been smelling a strong chemical smell from his body which he has never smelled before and which he cannot get rid of and which is driving him crazy) and HYPERHIDROSIS (Sometimes he gets sweaty when doing something). At the time of the report, SKIN ODOUR ABNORMAL (Has been smelling a strong chemical smell from his body which he has never smelled before and which he cannot get rid of and which is driving him crazy) had not resolved and HYPERHIDROSIS (Sometimes he gets sweaty when doing something) outcome was unknown.            Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Outcome of the event Skin odour abnormal updated.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with LIDOCAINE for Pain in arm, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] for Pain in arm, at an unspecified dose and frequency and GOODY for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided. On an unknown date,the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) in her right arm..  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Some people got worst headache after receiving 2nd dose; 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 HEADACHE (Some people got worst headache after receiving 2nd dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HEADACHE (Some people got worst headache after receiving 2nd dose). At the time of the report, HEADACHE (Some people got worst headache after receiving 2nd dose) outcome was unknown. Not Provided          Treatment medication was not provided.  Concomitant medication was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-080172 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080172:Cross-Linked case
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Slight fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever of 103) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight fever of 103). At the time of the report, PYREXIA (Slight fever of 103) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) Unknown.         No concomitant medication reported. Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided..  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-080013 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080013:2nd dose case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Pyrexia, Vaccination site mass, Vomiting
Clinical narrative: Dizziness; Fever; Throwing up voilently; Knot at injection site; Felt there is bubbles in her ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (Knot at injection site), EAR DISCOMFORT (Felt there is bubbles in her ear), DIZZINESS (Dizziness), VOMITING (Throwing up voilently) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included MECLIZINE HCL for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE MASS (Knot at injection site), EAR DISCOMFORT (Felt there is bubbles in her ear) and VOMITING (Throwing up voilently). On 12-Apr-2021, the patient experienced DIZZINESS (Dizziness) and PYREXIA (Fever). At the time of the report, VACCINATION SITE MASS (Knot at injection site), EAR DISCOMFORT (Felt there is bubbles in her ear), DIZZINESS (Dizziness), VOMITING (Throwing up voilently) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details include, pharmacist recommended dexamethasone,but it did not help her. She gave consent to follow up with safety.She asked whether she should take the second dose of the vaccine   This case was linked to MOD-2021-142085 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: The caller is returning safety's call to request the correct email address. Case #MOD2021142085 On 09-Jun-2021: The caller is returning safety's call to request the correct email address. Case #MOD2021142085
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue
Clinical narrative: Lost apatite for a day; Really tired for a day; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost apatite for a day) and FATIGUE (Really tired for a day) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Eye disorder.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced DECREASED APPETITE (Lost apatite for a day) and FATIGUE (Really tired for a day). On 07-Jan-2021, DECREASED APPETITE (Lost apatite for a day) and FATIGUE (Really tired for a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080012 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080012:Dose 2
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Nasopharyngitis
Clinical narrative: Not feeling good; Cold like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Not feeling good) and NASOPHARYNGITIS (Cold like symptoms) 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 23-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 DEPRESSED MOOD (Not feeling good) and NASOPHARYNGITIS (Cold like symptoms). At the time of the report, DEPRESSED MOOD (Not feeling good) and NASOPHARYNGITIS (Cold like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient takes concomitant medication but was unable to remember. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Second rash was itchy; Second rash was on her shoulder across her breast and on her stomach area as well as on her left forearm; First rash on her arm and all over her front torso; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Second rash was itchy), RASH (Second rash was on her shoulder across her breast and on her stomach area as well as on her left forearm) and RASH (First rash on her arm and all over her front torso) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (First rash on her arm and all over her front torso). On 07-Apr-2021, the patient experienced RASH PRURITIC (Second rash was itchy) and RASH (Second rash was on her shoulder across her breast and on her stomach area as well as on her left forearm). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Second rash was itchy), RASH (Second rash was on her shoulder across her breast and on her stomach area as well as on her left forearm) and RASH (First rash on her arm and all over her front torso) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported.  It was reported that patient took Claritin for both her rashes as treatment but it helped for the first rash but not for the second rash.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Pain, Pyrexia
Clinical narrative: fever; pain; hot; burning; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), PAIN (pain), FEELING HOT (hot) and BURNING SENSATION (burning) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced PYREXIA (fever), PAIN (pain), FEELING HOT (hot) and BURNING SENSATION (burning). At the time of the report, PYREXIA (fever), PAIN (pain), FEELING HOT (hot) and BURNING SENSATION (burning) outcome was unknown.            No relevant concomitant medication was reported.  Treatment information was not provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Miliaria, Rash, Rash pruritic
Clinical narrative: The rash gets hot and itchy at night; The rash gets hot and itchy at night; Rash; This spontaneous case was reported by a consumer and describes the occurrence of MILIARIA (The rash gets hot and itchy at night), RASH PRURITIC (The rash gets hot and itchy at night) and RASH (Rash) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Eye disorder.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced MILIARIA (The rash gets hot and itchy at night), RASH PRURITIC (The rash gets hot and itchy at night) and RASH (Rash). At the time of the report, MILIARIA (The rash gets hot and itchy at night), RASH PRURITIC (The rash gets hot and itchy at night) and RASH (Rash) had not resolved.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to US-MODERNATX, INC.-MOD-2021-080006 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080006:Dose 1