chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Neck pain, Rash
Clinical narrative: rash left arm/reddening left arm injection site; Neck pain; sore left arm at the injection site that worsened; reddening left arm injection site; burning left arm at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (sore left arm at the injection site that worsened), INJECTION SITE ERYTHEMA (reddening left arm injection site), INJECTION SITE PAIN (burning left arm at injection site), NECK PAIN (Neck pain) and RASH (rash left arm/reddening left arm injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced INJECTION SITE PAIN (sore left arm at the injection site that worsened), INJECTION SITE ERYTHEMA (reddening left arm injection site) and INJECTION SITE PAIN (burning left arm at injection site). On 26-Apr-2021, the patient experienced NECK PAIN (Neck pain). On 28-Apr-2021, the patient experienced RASH (rash left arm/reddening left arm injection site). The patient was treated with HYDROCORTISONE ACETATE (HEMORRHOID) (topical) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (sore left arm at the injection site that worsened), INJECTION SITE ERYTHEMA (reddening left arm injection site), INJECTION SITE PAIN (burning left arm at injection site), NECK PAIN (Neck pain) and RASH (rash left arm/reddening left arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include  blood pressure, anxiety and acid reflux medications. Patient was advised to use ice as treatment and also instructed by her healthcare provider to use a warm compress.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient has not received second dose of vaccine till day 48; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not received second dose of vaccine till day 48) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not received second dose of vaccine till day 48). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not received second dose of vaccine till day 48) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Oropharyngeal discomfort
Clinical narrative: patient felt like there was something in her throat; Patient felt more dizzy; Trouble breathing which got worse; Patient started feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Patient started feeling dizzy), DYSPNOEA (Trouble breathing which got worse), OROPHARYNGEAL DISCOMFORT (patient felt like there was something in her throat) and DIZZINESS (Patient felt more dizzy) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006CZIA) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 23-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced DIZZINESS (Patient started feeling dizzy). On 25-Apr-2021, the patient experienced DYSPNOEA (Trouble breathing which got worse). On 26-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (patient felt like there was something in her throat) and DIZZINESS (Patient felt more dizzy). On 25-Apr-2021, DIZZINESS (Patient started feeling dizzy) had resolved. At the time of the report, DYSPNOEA (Trouble breathing which got worse) and OROPHARYNGEAL DISCOMFORT (patient felt like there was something in her throat) outcome was unknown and DIZZINESS (Patient felt more dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medications information provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: A little bit of a headache all week; recurrent fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (A little bit of a headache all week) and PYREXIA (recurrent fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included ENALAPRIL for Blood pressure high, SIMVASTATIN for Cholesterol, ESTRADIOL;PROGESTERONE for Menopause, VITAMIN B12 NOS, CALCIUM and COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] for an unknown indication.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HEADACHE (A little bit of a headache all week) and PYREXIA (recurrent fever). The patient was treated with IBUPROFEN for Fever and Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (A little bit of a headache all week) outcome was unknown and PYREXIA (recurrent fever) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 30-May-2021: Email
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old female inadvertently given the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female inadvertently given the first dose) in a 14-year-old female patient who received mRNA-1273 (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female inadvertently given the first dose). On 28-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female inadvertently given the first dose) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: NNI
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain
Clinical narrative: body ache; muscle ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), MYALGIA (muscle ache) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN (body ache), MYALGIA (muscle ache) and CHILLS (chills). On 10-Apr-2021, PAIN (body ache), MYALGIA (muscle ache) and CHILLS (chills) had resolved.            2 days after the symptom patient drank two cans of Beers. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: red rash at injection site; itching at injection site; red rash at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (red rash at injection site), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (red rash at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (red rash at injection site), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (red rash at injection site). At the time of the report, VACCINATION SITE RASH (red rash at injection site), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (red rash at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Muscular weakness, Nerve conduction studies, Pain in extremity
Clinical narrative: Severe Left Arm Pain; Weakness in the entire Left Arm (Left Shoulder to hand); This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Severe Left Arm Pain) and MUSCULAR WEAKNESS (Weakness in the entire Left Arm (Left Shoulder to hand)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe Left Arm Pain) and MUSCULAR WEAKNESS (Weakness in the entire Left Arm (Left Shoulder to hand)). The patient was treated with GABAPENTIN for Pain, at a dose of 300mg AM and 200mg HS; Physical therapy for Pain in extremity and Physical therapy for Muscular weakness. At the time of the report, PAIN IN EXTREMITY (Severe Left Arm Pain) and MUSCULAR WEAKNESS (Weakness in the entire Left Arm (Left Shoulder to hand)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal normal. On an unknown date, Nerve conduction studies: normal normal.     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.   Treatment medication Gabapentin 300mg AM and 200mg HS (500mg/day), which reduced the pain from 10/10 to a 4/10. The patient also tried physical therapy, however that discontinued as patient was financially unable to continue.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Missed scheduled second dose; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed scheduled second dose), CHILLS (Chills) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed scheduled second dose), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with BAMLANIVIMAB on 01-Mar-2021 at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed scheduled second dose) had resolved and CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, SARS-CoV-2 test: positive (Positive) Tested positive  couple of days before patient was suppose to receive the second dose..     The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Peripheral swelling, Pruritus
Clinical narrative: Swollen hands; Hands are Itchy; Sweating; flu-like symptoms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen hands), PRURITUS (Hands are Itchy), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 28-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 29-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (Chills). On 30-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen hands) and PRURITUS (Hands are Itchy). On 29-Apr-2021, HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (Chills) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen hands) and PRURITUS (Hands are Itchy) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: "generalize redness" in injection site area; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA ("generalize redness" in injection site area) and VACCINATION SITE PRURITUS (itchiness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA ("generalize redness" in injection site area) and VACCINATION SITE PRURITUS (itchiness). At the time of the report, VACCINATION SITE ERYTHEMA ("generalize redness" in injection site area) and VACCINATION SITE PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient used Hydrocortisone cream as treatment for the events.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain after the second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain after the second dose of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) 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, the patient experienced MYALGIA (pain after the second dose of the vaccine). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, MYALGIA (pain after the second dose of the vaccine) outcome was unknown.            Patient was told to take Tylenol instead she took ibuprofen. Action taken with mRNA-1273 in response to the event was not applicable
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Insomnia, Pain in extremity, Pruritus
Clinical narrative: It's itchy; It's red; Cannot sleep; scratch; "bad rash"; Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"), PRURITUS (It's itchy), ERYTHEMA (It's red), INSOMNIA (Cannot sleep) and SCRATCH (scratch) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"). On an unknown date, the patient experienced PRURITUS (It's itchy), ERYTHEMA (It's red), INSOMNIA (Cannot sleep), SCRATCH (scratch) and RASH ("bad rash"). At the time of the report, HYPERSENSITIVITY (Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"), PRURITUS (It's itchy) and RASH ("bad rash") had not resolved, ERYTHEMA (It's red), INSOMNIA (Cannot sleep) and SCRATCH (scratch) outcome was unknown and PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Eucrisa, Mometasone furoate (0.1%) and Hydroxyzine (10 mg) are the treatment medication reported by reporter.  The patient had question if it is safe to take second dose of vaccine which is due on 05May2021 as she never healed from the "bad rash" and her "arm look ugly", "cannot were long sleeve as it itches a lot" and is uncomfortable. The patient did not have pre-existing medical condition as such. The patient said she had some allergy last year during 2021 but she did not go to any doctor due to pandemic lockdown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Scratch
Clinical narrative: It's itchy; It's red; Cannot sleep; scratch; "bad rash"; Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"), PRURITUS (It's itchy), ERYTHEMA (It's red), INSOMNIA (Cannot sleep) and SCRATCH (scratch) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 21-Apr-2021, the patient experienced HYPERSENSITIVITY (Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"). On an unknown date, the patient experienced PRURITUS (It's itchy), ERYTHEMA (It's red), INSOMNIA (Cannot sleep), SCRATCH (scratch) and RASH ("bad rash"). At the time of the report, HYPERSENSITIVITY (Bad allergic reaction, allergy spread to her other arm". Eventually it "spread to all over her arm", "chest", "stomach" and "back"), PRURITUS (It's itchy) and RASH ("bad rash") had not resolved, ERYTHEMA (It's red), INSOMNIA (Cannot sleep) and SCRATCH (scratch) outcome was unknown and PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Eucrisa, Mometasone furoate (0.1%) and Hydroxyzine (10 mg) are the treatment medication reported by reporter.  The patient had question if it is safe to take second dose of vaccine which is due on 05May2021 as she never healed from the "bad rash" and her "arm look ugly", "cannot were long sleeve as it itches a lot" and is uncomfortable. The patient did not have pre-existing medical condition as such. The patient said she had some allergy last year during 2021 but she did not go to any doctor due to pandemic lockdown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: Received the 2nd dose of Moderna vaccine and would like to participate in Pregnancy Registry; Injection arm soreness (left arm ); This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the 2nd dose of Moderna vaccine and would like to participate in Pregnancy Registry) and VACCINATION SITE PAIN (Injection arm soreness (left arm )) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 044A21A) for COVID-19 vaccination.     No medical history were reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Dec-2020 and the estimated date of delivery was 28-Sep-2021. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Injection arm soreness (left arm )). On 30-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the 2nd dose of Moderna vaccine and would like to participate in Pregnancy Registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 30-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received the 2nd dose of Moderna vaccine and would like to participate in Pregnancy Registry) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection arm soreness (left arm )) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph node) 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 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph node). At the time of the report, LYMPHADENOPATHY (Swollen Lymph node) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Hard spot on arm where the injection was given, that is "itchy"; Hard spot on arm where the injection was given, that is "red"; Hard spot on the arm where the injection was given; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE PRURITUS (Hard spot on arm where the injection was given, that is "itchy"), VACCINATION SITE ERYTHEMA (Hard spot on arm where the injection was given, that is "red") and VACCINATION SITE INDURATION (Hard spot on the arm where the injection was given) 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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 30-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Hard spot on arm where the injection was given, that is "itchy"), VACCINATION SITE ERYTHEMA (Hard spot on arm where the injection was given, that is "red") and VACCINATION SITE INDURATION (Hard spot on the arm where the injection was given). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown and VACCINATION SITE PRURITUS (Hard spot on arm where the injection was given, that is "itchy"), VACCINATION SITE ERYTHEMA (Hard spot on arm where the injection was given, that is "red") and VACCINATION SITE INDURATION (Hard spot on the arm where the injection was given) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypokinesia, Pain in extremity, Pruritus, Vaccination site pain
Clinical narrative: a very sore arm,; hot arm; itchy arm; it hurt to lift the arm with muscle muscle part of her arm, almost has to help with the other hand; pain shoots up from the elbow to about the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a very sore arm,), FEELING HOT (hot arm), PRURITUS (itchy arm), HYPOKINESIA (it hurt to lift the arm with muscle muscle part of her arm, almost has to help with the other hand) and VACCINATION SITE PAIN (pain shoots up from the elbow to about the site of injection) in a 73-year-old female patient who received mRNA-1273 (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN for Cholesterol, GABAPENTIN, COLECALCIFEROL (VITAMIN D3), FISH OIL, CALCIUM and UBIDECARENONE (COQ-10) for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (a very sore arm,), FEELING HOT (hot arm), PRURITUS (itchy arm), HYPOKINESIA (it hurt to lift the arm with muscle muscle part of her arm, almost has to help with the other hand) and VACCINATION SITE PAIN (pain shoots up from the elbow to about the site of injection). At the time of the report, PAIN IN EXTREMITY (a very sore arm,), FEELING HOT (hot arm), PRURITUS (itchy arm), HYPOKINESIA (it hurt to lift the arm with muscle muscle part of her arm, almost has to help with the other hand) and VACCINATION SITE PAIN (pain shoots up from the elbow to about the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Treatment medication included Acetaminophen. No lab data has been provided by the reporter.
Age: 66.0
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 a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included blood pressure and thyroid medications. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DIZZINESS (Light headed). At the time of the report, DIZZINESS (Light headed) outcome was unknown.            No concomitant medications provided. No treatment information provided.   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of chills in an 83-year-old female patient who received mRNA-1273 (batch# 050M20A) for COVID-19 vaccination. No medical history information reported. On Mar 11, 2021, patient received the second dose of mRNA-1273 intramuscular; 1 dosage form. On Mar 11, 2021, patient experienced chills. On Mar 12, 2021, chills resolved. Action taken with respect to mRNA-1273: not applicable. The reporter did not provide any causality assessments, concomitant medication or treatment information. Additional information provided: Patient updated contact information from linked case and consented for safety follow-up. This case linked to MOD-2021-026023 (patient link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling abnormal, Hyperhidrosis, Illness
Clinical narrative: She planned to get the 2nd vaccine, but she is unable to the get it; Breaking out with cold sweat; Shaking like a junkie; Feels just as bad as the vaccine as I did with COVID; Loose bowels; So sick; Nausea; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Breaking out with cold sweat), TREMOR (Shaking like a junkie), FEELING ABNORMAL (Feels just as bad as the vaccine as I did with COVID), DIARRHOEA (Loose bowels) and ILLNESS (So sick) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B2 1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Degenerative disc disease (L4-L7).    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HYPERHIDROSIS (Breaking out with cold sweat), TREMOR (Shaking like a junkie), FEELING ABNORMAL (Feels just as bad as the vaccine as I did with COVID), DIARRHOEA (Loose bowels), ILLNESS (So sick), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills). On 22-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She planned to get the 2nd vaccine, but she is unable to the get it). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency. On 22-Jul-2021, PRODUCT DOSE OMISSION ISSUE (She planned to get the 2nd vaccine, but she is unable to the get it) had resolved. At the time of the report, HYPERHIDROSIS (Breaking out with cold sweat), TREMOR (Shaking like a junkie), FEELING ABNORMAL (Feels just as bad as the vaccine as I did with COVID), DIARRHOEA (Loose bowels), ILLNESS (So sick), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: TCR received contain significant information,updated outcome of all events from unknown to recovered and an event missed dose added.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Product dose omission issue, Pyrexia, Tremor
Clinical narrative: She planned to get the 2nd vaccine, but she is unable to the get it; Breaking out with cold sweat; Shaking like a junkie; Feels just as bad as the vaccine as I did with COVID; Loose bowels; So sick; Nausea; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Breaking out with cold sweat), TREMOR (Shaking like a junkie), FEELING ABNORMAL (Feels just as bad as the vaccine as I did with COVID), DIARRHOEA (Loose bowels) and ILLNESS (So sick) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B2 1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Degenerative disc disease (L4-L7).    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HYPERHIDROSIS (Breaking out with cold sweat), TREMOR (Shaking like a junkie), FEELING ABNORMAL (Feels just as bad as the vaccine as I did with COVID), DIARRHOEA (Loose bowels), ILLNESS (So sick), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills). On 22-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She planned to get the 2nd vaccine, but she is unable to the get it). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency. On 22-Jul-2021, PRODUCT DOSE OMISSION ISSUE (She planned to get the 2nd vaccine, but she is unable to the get it) had resolved. At the time of the report, HYPERHIDROSIS (Breaking out with cold sweat), TREMOR (Shaking like a junkie), FEELING ABNORMAL (Feels just as bad as the vaccine as I did with COVID), DIARRHOEA (Loose bowels), ILLNESS (So sick), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: TCR received contain significant information,updated outcome of all events from unknown to recovered and an event missed dose added.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Myalgia
Clinical narrative: Bruises on both legs; Extremely tired; Achy all over; This spontaneous case was reported by a pharmacist and describes the occurrence of CONTUSION (Bruises on both legs), FATIGUE (Extremely tired) and MYALGIA (Achy all over) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced CONTUSION (Bruises on both legs), FATIGUE (Extremely tired) and MYALGIA (Achy all over). At the time of the report, CONTUSION (Bruises on both legs), FATIGUE (Extremely tired) and MYALGIA (Achy all over) 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.   Concomitant and treatment medication were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced INJECTION SITE RASH (Rash at the injection site). On 29-Mar-2021, INJECTION SITE RASH (Rash at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Product use issue, Vaccination site pain
Clinical narrative: First dose is considered invalid by CDC; pain on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on the site of injection) and PRODUCT USE ISSUE (First dose is considered invalid by CDC) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain on the site of injection). On 21-Apr-2021, the patient experienced PRODUCT USE ISSUE (First dose is considered invalid by CDC). At the time of the report, VACCINATION SITE PAIN (pain on the site of injection) and PRODUCT USE ISSUE (First dose is considered invalid by CDC) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain on the site of injection) and PRODUCT USE ISSUE (First dose is considered invalid by CDC) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain on the site of injection). On 21-Apr-2021, the patient experienced PRODUCT USE ISSUE (First dose is considered invalid by CDC). At the time of the report, VACCINATION SITE PAIN (pain on the site of injection) and PRODUCT USE ISSUE (First dose is considered invalid by CDC) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 15APR2021, post vaccination, the patient reported that he experienced flu-like symptoms and pain at the site of his injection.   No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-101207 (E2B Linked Report).   This case was linked to US-MODERNATX, INC.-MOD-2021-101207 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101207:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea exertional, Fatigue
Clinical narrative: Shortness of Breath after running; Lightheadedness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA EXERTIONAL (Shortness of Breath after running), DIZZINESS (Lightheadedness) and FATIGUE (Fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) 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) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Lightheadedness). 25-Feb-2021, the patient experienced FATIGUE (Fatigue). On 04-Mar-2021, the patient experienced DYSPNOEA EXERTIONAL (Shortness of Breath after running). At the time of the report, DYSPNOEA EXERTIONAL (Shortness of Breath after running) and DIZZINESS (Lightheadedness) outcome was unknown and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked toMOD-2021-100844 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded MOD-2021-100844:Case for secnd dose
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rash pruritic
Clinical narrative: Body Wide Rash that started 1 day after getting vaccine/ rash is itchy; Hacky cough and lungs are itchy/ Once she starts coughing it is hard to stop; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Body Wide Rash that started 1 day after getting vaccine/ rash is itchy) and COUGH (Hacky cough and lungs are itchy/ Once she starts coughing it is hard to stop) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Reactive airways disease (Reactive lungs.), Drug allergy (Allergy to steroids.) and Drug allergy (Allergy to oral benadryl.).    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced RASH PRURITIC (Body Wide Rash that started 1 day after getting vaccine/ rash is itchy) and COUGH (Hacky cough and lungs are itchy/ Once she starts coughing it is hard to stop). The patient was treated with FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) at an unspecified dose and frequency and ZINC OXIDE at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Body Wide Rash that started 1 day after getting vaccine/ rash is itchy) and COUGH (Hacky cough and lungs are itchy/ Once she starts coughing it is hard to stop) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included topical Benadryl and baking soda made into a paste applied topically and Allegra 24 Hour by mouth. No concomitant medication information was provided    Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up information received and contains No new information
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm pain) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced INJECTION SITE PAIN (Arm pain). At the time of the report, INJECTION SITE PAIN (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: rash itches; rash on her arm where she received the vaccination; rash became swollen; rash became red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (rash itches), VACCINATION SITE RASH (rash on her arm where she received the vaccination), VACCINATION SITE SWELLING (rash became swollen) and VACCINATION SITE ERYTHEMA (rash became red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (rash itches), VACCINATION SITE RASH (rash on her arm where she received the vaccination), VACCINATION SITE SWELLING (rash became swollen) and VACCINATION SITE ERYTHEMA (rash became red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (rash itches), VACCINATION SITE RASH (rash on her arm where she received the vaccination), VACCINATION SITE SWELLING (rash became swollen) and VACCINATION SITE ERYTHEMA (rash became red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose 7 days after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 7 days after 1st dose) in an 83-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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 7 days after 1st dose). On 30-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 7 days after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Additional Information received included no new significant information. On 26-Jul-2021: Additional Information received included no new significant information. Race and ethnic group updated.