chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Hyperhidrosis, Oropharyngeal pain
Clinical narrative: sore throat red and swollen with white patches; sore throat red and swollen with white patches; sore throat red and swollen with white patches; sweating; joints are achy; tired can't get out of bed; so tired with shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat red and swollen with white patches), PHARYNGEAL ERYTHEMA (sore throat red and swollen with white patches), PHARYNGEAL SWELLING (sore throat red and swollen with white patches), HYPERHIDROSIS (sweating) and ARTHRALGIA (joints are achy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 073M70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung disorder NOS (compromised lungs).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat red and swollen with white patches), PHARYNGEAL ERYTHEMA (sore throat red and swollen with white patches), PHARYNGEAL SWELLING (sore throat red and swollen with white patches), HYPERHIDROSIS (sweating), ARTHRALGIA (joints are achy), FATIGUE (tired can't get out of bed) and DYSPNOEA (so tired with shortness of breath). At the time of the report, OROPHARYNGEAL PAIN (sore throat red and swollen with white patches), PHARYNGEAL ERYTHEMA (sore throat red and swollen with white patches), PHARYNGEAL SWELLING (sore throat red and swollen with white patches), HYPERHIDROSIS (sweating), ARTHRALGIA (joints are achy), FATIGUE (tired can't get out of bed) and DYSPNOEA (so tired with shortness of breath) 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 medications were not provided.  Treatment details included Tylenol, Pepcid.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal erythema, Pharyngeal swelling
Clinical narrative: sore throat red and swollen with white patches; sore throat red and swollen with white patches; sore throat red and swollen with white patches; sweating; joints are achy; tired can't get out of bed; so tired with shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat red and swollen with white patches), PHARYNGEAL ERYTHEMA (sore throat red and swollen with white patches), PHARYNGEAL SWELLING (sore throat red and swollen with white patches), HYPERHIDROSIS (sweating) and ARTHRALGIA (joints are achy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 073M70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung disorder NOS (compromised lungs).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat red and swollen with white patches), PHARYNGEAL ERYTHEMA (sore throat red and swollen with white patches), PHARYNGEAL SWELLING (sore throat red and swollen with white patches), HYPERHIDROSIS (sweating), ARTHRALGIA (joints are achy), FATIGUE (tired can't get out of bed) and DYSPNOEA (so tired with shortness of breath). At the time of the report, OROPHARYNGEAL PAIN (sore throat red and swollen with white patches), PHARYNGEAL ERYTHEMA (sore throat red and swollen with white patches), PHARYNGEAL SWELLING (sore throat red and swollen with white patches), HYPERHIDROSIS (sweating), ARTHRALGIA (joints are achy), FATIGUE (tired can't get out of bed) and DYSPNOEA (so tired with shortness of breath) 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 medications were not provided.  Treatment details included Tylenol, Pepcid.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: she is starting to itch on vaccination arm and is moving to chest and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (she is starting to itch on vaccination arm and is moving to chest and shoulder) in a 37-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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRURITUS (she is starting to itch on vaccination arm and is moving to chest and shoulder). At the time of the report, PRURITUS (she is starting to itch on vaccination arm and is moving to chest and shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on arm of the injection and it is spreading down to their elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on arm of the injection and it is spreading down to their elbow) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE RASH (rash on arm of the injection and it is spreading down to their elbow). At the time of the report, VACCINATION SITE RASH (rash on arm of the injection and it is spreading down to their elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigued to the point can barely walk; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued to the point can barely walk) in a 77-year-old female patient 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 FATIGUE (Fatigued to the point can barely walk). At the time of the report, FATIGUE (Fatigued to the point can barely walk) outcome was unknown.            concomitant medicines was not reported by reporter  treatment information was not provided  Action taken with the mRNA-1273 in response to event is not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Want to know if there is something we can do to not cause fatigue or at least fix the condition fatigue.    .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Bad headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Bad headaches). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and HEADACHE (Bad headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications were not reported.   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant FU received on 28-Jul-2021, Sore arm event outcome updated.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash of 3inches across his arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination. The patient's past medical history included Bypass surgery and Heart attack (several heart attacks). Concurrent medical conditions included Cancer. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH ERYTHEMATOUS (Red rash of 3inches across his arm). At the time of the report, RASH ERYTHEMATOUS (Red rash of 3inches across his arm) outcome was unknown. This case was linked to MOD-2021-051915.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dehydration, Dizziness, Headache, Nausea
Clinical narrative: Headache; Nausea/ nauseous; Vomiting; Fever 100.2 Fahrenheit; Dizzy; Dehydrated; Her Arm was sore for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DEHYDRATION (Dehydrated), VACCINATION SITE PAIN (Her Arm was sore for 2 days), HEADACHE (Headache) and NAUSEA (Nausea/ nauseous) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 206M20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Her Arm was sore for 2 days). On 14-Mar-2021, the patient experienced DIZZINESS (Dizzy), DEHYDRATION (Dehydrated), HEADACHE (Headache), NAUSEA (Nausea/ nauseous), VOMITING (Vomiting) and PYREXIA (Fever 100.2 Fahrenheit). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 15-Mar-2021, VACCINATION SITE PAIN (Her Arm was sore for 2 days) had resolved. On 18-Mar-2021, DEHYDRATION (Dehydrated), HEADACHE (Headache), VOMITING (Vomiting) and PYREXIA (Fever 100.2 Fahrenheit) had resolved. At the time of the report, DIZZINESS (Dizzy) and NAUSEA (Nausea/ nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) 100.2 Fahrenheit.         The patient's arm was sore for 2 days and had vomiting x 20 times. On 16-Mar-2021, the patient could hold food in stomach but still felt nauseous and dizzy.   This case was linked to US-MODERNATX, INC.-MOD-2021-051923 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-051923:1st dose
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Headache; Nausea/ nauseous; Vomiting; Fever 100.2 Fahrenheit; Dizzy; Dehydrated; Her Arm was sore for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DEHYDRATION (Dehydrated), VACCINATION SITE PAIN (Her Arm was sore for 2 days), HEADACHE (Headache) and NAUSEA (Nausea/ nauseous) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 206M20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Her Arm was sore for 2 days). On 14-Mar-2021, the patient experienced DIZZINESS (Dizzy), DEHYDRATION (Dehydrated), HEADACHE (Headache), NAUSEA (Nausea/ nauseous), VOMITING (Vomiting) and PYREXIA (Fever 100.2 Fahrenheit). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 15-Mar-2021, VACCINATION SITE PAIN (Her Arm was sore for 2 days) had resolved. On 18-Mar-2021, DEHYDRATION (Dehydrated), HEADACHE (Headache), VOMITING (Vomiting) and PYREXIA (Fever 100.2 Fahrenheit) had resolved. At the time of the report, DIZZINESS (Dizzy) and NAUSEA (Nausea/ nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) 100.2 Fahrenheit.         The patient's arm was sore for 2 days and had vomiting x 20 times. On 16-Mar-2021, the patient could hold food in stomach but still felt nauseous and dizzy.   This case was linked to US-MODERNATX, INC.-MOD-2021-051923 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-051923:1st dose
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Eating disorder, Fatigue, Illness
Clinical narrative: Burning up; Doesnt feel like eating; Feels like a zombie; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning up), EATING DISORDER (Doesnt feel like eating), ILLNESS (Feels like a zombie) and FATIGUE (Fatigued) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001176) 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) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced BURNING SENSATION (Burning up), EATING DISORDER (Doesnt feel like eating), ILLNESS (Feels like a zombie) and FATIGUE (Fatigued). At the time of the report, BURNING SENSATION (Burning up), EATING DISORDER (Doesnt feel like eating), ILLNESS (Feels like a zombie) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported No treatment medication was reported
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Her chest, her arms, almost all the body is swelled; Red; Itchy; Her skin is breaking up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Her chest, her arms, almost all the body is swelled), ERYTHEMA (Red), PRURITUS (Itchy) and RASH (Her skin is breaking up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced SWELLING (Her chest, her arms, almost all the body is swelled), ERYTHEMA (Red), PRURITUS (Itchy) and RASH (Her skin is breaking up). At the time of the report, SWELLING (Her chest, her arms, almost all the body is swelled), ERYTHEMA (Red), PRURITUS (Itchy) and RASH (Her skin is breaking up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Insomnia
Clinical narrative: Cant sleep for the last 8 days; dizziness; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Cant sleep for the last 8 days), DIZZINESS (dizziness) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INSOMNIA (Cant sleep for the last 8 days), DIZZINESS (dizziness) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INSOMNIA (Cant sleep for the last 8 days), DIZZINESS (dizziness) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Lip swelling, Pruritus, Swelling, Urticaria
Clinical narrative: Swollen lips; Dizziness; Itchy arm; Hives in the arm; Bumps; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lips), DIZZINESS (Dizziness), PRURITUS (Itchy arm), URTICARIA (Hives in the arm) and SWELLING (Bumps) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced LIP SWELLING (Swollen lips), DIZZINESS (Dizziness), PRURITUS (Itchy arm), URTICARIA (Hives in the arm) and SWELLING (Bumps). At the time of the report, LIP SWELLING (Swollen lips), DIZZINESS (Dizziness), PRURITUS (Itchy arm), URTICARIA (Hives in the arm) and SWELLING (Bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up information received and AE contact information updated.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysgeusia, Pyrexia
Clinical narrative: metallic taste; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste), PYREXIA (fever) and CHILLS (chills) 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 DYSGEUSIA (metallic taste), PYREXIA (fever) and CHILLS (chills). At the time of the report, DYSGEUSIA (metallic taste), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No Concomitant medication provided.  No treatment drugs were provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Injection site pain, Myalgia, Sleep deficit
Clinical narrative: overall weakness; AE kept him up all night; chills/shivers; body aches; Pain from the injection site seemed to exacerbate these adverse events and symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (overall weakness), SLEEP DEFICIT (AE kept him up all night), CHILLS (chills/shivers), MYALGIA (body aches) and INJECTION SITE PAIN (Pain from the injection site seemed to exacerbate these adverse events and symptoms) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A219A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-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 18-Mar-2021, the patient experienced SLEEP DEFICIT (AE kept him up all night), CHILLS (chills/shivers), MYALGIA (body aches) and INJECTION SITE PAIN (Pain from the injection site seemed to exacerbate these adverse events and symptoms). On 19-Mar-2021, the patient experienced ASTHENIA (overall weakness). On 19-Mar-2021, SLEEP DEFICIT (AE kept him up all night), CHILLS (chills/shivers), MYALGIA (body aches) and INJECTION SITE PAIN (Pain from the injection site seemed to exacerbate these adverse events and symptoms) had resolved. At the time of the report, ASTHENIA (overall weakness) had not resolved.            No concomitant and treatment medication information was reported.   This case was linked to MOD-2021-023235 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: local soreness; warm  and itchy at injection site; warm and itchy at injection site; swelling at injection site; big area of redness on her arm like a bee sting, redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm  and itchy at injection site), INJECTION SITE PRURITUS (warm and itchy at injection site), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE ERYTHEMA (big area of redness on her arm like a bee sting, redness at injection site) and INJECTION SITE PAIN (local soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (Slightly elevated Blood pressure) since May 2014, Depression, Osteopenia since 2001 and Anxiety since 2015. Concomitant products included ESCITALOPRAM for Anxiety, METOPROLOL and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) for Blood pressure, ALENDRONATE SODIUM (ALENDRONATE), CALCIUM CITRATE and VITAMIN D3 for Osteopenia, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Prevention.    On 16-Feb-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm  and itchy at injection site), INJECTION SITE PRURITUS (warm and itchy at injection site), INJECTION SITE SWELLING (swelling at injection site) and INJECTION SITE ERYTHEMA (big area of redness on her arm like a bee sting, redness at injection site). On an unknown date, the patient experienced INJECTION SITE PAIN (local soreness). The patient was treated with HYDROCORTISONE (topical) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (CALADRYL [DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) (topical) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, INJECTION SITE WARMTH (warm  and itchy at injection site), INJECTION SITE PRURITUS (warm and itchy at injection site), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE ERYTHEMA (big area of redness on her arm like a bee sting, redness at injection site) and INJECTION SITE PAIN (local soreness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient spoke with physician about reaction to the first shot but was not concerned as she had heard about others with the delayed itching/redness/swelling reaction.   This case was linked to MOD-2021-122693 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: updated medical history, concomitant medications, added events, updated vaccine administration information, updated action taken with vaccine, and causality for all events based on patient response.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Heat; Redness at injection site; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L204) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness). At the time of the report, VACCINATION SITE WARMTH (Heat), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-052035 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Peripheral swelling
Clinical narrative: swollen arm; dizziness; vomiting; nauseas; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizziness), VOMITING (vomiting), NAUSEA (nauseas) and HEADACHE (headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had Covid-19 in November 2020.). Concomitant products included LEVOTHYROXINE, VALSARTAN, PRAVASTATINE [PRAVASTATIN] and PANTOPRAZOLE for an unknown indication.    On 12-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 PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizziness), VOMITING (vomiting), NAUSEA (nauseas), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizziness), VOMITING (vomiting), NAUSEA (nauseas), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: swollen arm; dizziness; vomiting; nauseas; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizziness), VOMITING (vomiting), NAUSEA (nauseas) and HEADACHE (headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had Covid-19 in November 2020.). Concomitant products included LEVOTHYROXINE, VALSARTAN, PRAVASTATINE [PRAVASTATIN] and PANTOPRAZOLE for an unknown indication.    On 12-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 PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizziness), VOMITING (vomiting), NAUSEA (nauseas), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen arm), DIZZINESS (dizziness), VOMITING (vomiting), NAUSEA (nauseas), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: minor pain in the arm; Little tired but not too tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor pain in the arm) and FATIGUE (Little tired but not too tired) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 06-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 PAIN IN EXTREMITY (minor pain in the arm) and FATIGUE (Little tired but not too tired). At the time of the report, PAIN IN EXTREMITY (minor pain in the arm) and FATIGUE (Little tired but not too tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant was not provided  Treatment was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-052007 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-052007:Crosslinked with husband case
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Heat in knees; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Heat in knees) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ARTHRITIS (Heat in knees). At the time of the report, ARTHRITIS (Heat in knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash started not just in her arm, all on her left side, it's a very large rash, it's worst; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash started not just in her arm, all on her left side, it's a very large rash, it's worst) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for an unknown indication.   On 16-Mar-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 18-Mar-2021, the patient experienced VACCINATION SITE RASH (rash started not just in her arm, all on her left side, it's a very large rash, it's worst). At the time of the report, VACCINATION SITE RASH (rash started not just in her arm, all on her left side, it's a very large rash, it's worst) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: There are 3 spots on her arm that are itchy; 1 spot feels hard like there is a lump; Red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (There are 3 spots on her arm that are itchy), INDURATION (1 spot feels hard like there is a lump) and ERYTHEMA (Red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A211A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (There are 3 spots on her arm that are itchy), INDURATION (1 spot feels hard like there is a lump) and ERYTHEMA (Red). At the time of the report, PRURITUS (There are 3 spots on her arm that are itchy), INDURATION (1 spot feels hard like there is a lump) and ERYTHEMA (Red) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient experienced spots were closer to her armpit and go down to her elbow.  Treatment information was not provided.   the action taken with the drug in response to the events was not applicable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Diplopia, Eyelid disorder
Clinical narrative: double vision; droopy eyelid; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIPLOPIA (double vision) and EYELID DISORDER (droopy eyelid) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cranial nerve disorder.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DIPLOPIA (double vision) and EYELID DISORDER (droopy eyelid). At the time of the report, DIPLOPIA (double vision) and EYELID DISORDER (droopy eyelid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal. In February 2021, Computerised tomogram: normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included birth control pills.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Hypersomnia
Clinical narrative: Experienced anxiety; Agitated all night; Slept for 6 days straight, day and night; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Experienced anxiety), AGITATION (Agitated all night) and HYPERSOMNIA (Slept for 6 days straight, day and night) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ANXIETY (Experienced anxiety), AGITATION (Agitated all night) and HYPERSOMNIA (Slept for 6 days straight, day and night). At the time of the report, ANXIETY (Experienced anxiety), AGITATION (Agitated all night) and HYPERSOMNIA (Slept for 6 days straight, day and night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Apathy, Chills, Headache
Clinical narrative: No ambition; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of APATHY (No ambition), CHILLS (chills) and HEADACHE (headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 05-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 APATHY (No ambition), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Chills, at a dose of 1 dosage form. At the time of the report, APATHY (No ambition), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-051532 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-051532:wife case
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Injection site soreness; Muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) and MYALGIA (Muscle soreness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness) and MYALGIA (Muscle soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) and MYALGIA (Muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Head discomfort, Nasopharyngitis
Clinical narrative: Head felt so sick; fatigue/exhausted; dizzy; chilly; cold; achy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), PAIN (achy), HEAD DISCOMFORT (Head felt so sick), DIZZINESS (dizzy) and CHILLS (chilly) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), PAIN (achy), DIZZINESS (dizzy) and CHILLS (chilly). On 18-Mar-2021, the patient experienced FATIGUE (fatigue/exhausted). On an unknown date, the patient experienced HEAD DISCOMFORT (Head felt so sick). At the time of the report, NASOPHARYNGITIS (cold), PAIN (achy), HEAD DISCOMFORT (Head felt so sick), DIZZINESS (dizzy), CHILLS (chilly) and FATIGUE (fatigue/exhausted) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications was included.  No treatment medications were reported.   This case was linked to MOD21-057846, MOD21-030427, MOD21-043912 (Patient Link).
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Head felt so sick; fatigue/exhausted; dizzy; chilly; cold; achy; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), PAIN (achy), HEAD DISCOMFORT (Head felt so sick), DIZZINESS (dizzy) and CHILLS (chilly) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), PAIN (achy), DIZZINESS (dizzy) and CHILLS (chilly). On 18-Mar-2021, the patient experienced FATIGUE (fatigue/exhausted). On an unknown date, the patient experienced HEAD DISCOMFORT (Head felt so sick). At the time of the report, NASOPHARYNGITIS (cold), PAIN (achy), HEAD DISCOMFORT (Head felt so sick), DIZZINESS (dizzy), CHILLS (chilly) and FATIGUE (fatigue/exhausted) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications was included.  No treatment medications were reported.   This case was linked to MOD21-057846, MOD21-030427, MOD21-043912 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Maculopapular itchy rash; Maculopapular itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULO-PAPULAR (Maculopapular itchy rash) and RASH PRURITIC (Maculopapular itchy rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced RASH MACULO-PAPULAR (Maculopapular itchy rash) and RASH PRURITIC (Maculopapular itchy rash). The patient was treated with BACITRACIN for Rash, at an unspecified dose and frequency. At the time of the report, RASH MACULO-PAPULAR (Maculopapular itchy rash) and RASH PRURITIC (Maculopapular itchy rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient's concomitant medications were not reported.   It was reported that the rash was as big as an orange on her vaccinated arm. The patient stated that the itchy rash went away after three and a half weeks.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Event Outcome was updated to recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Body temperature, Fatigue, Headache
Clinical narrative: Little stomach upset; Arm pain; Fever100.5 to 100.7 after 2nd dose; Severe headache; Severe muscle pain; Joint pain; Fatigue; Nausea; Swelling at site of vaccine; Swollen lymph node under left arm; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever100.5 to 100.7 after 2nd dose), HEADACHE (Severe headache) and MYALGIA (Severe muscle pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026L208a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever100.5 to 100.7 after 2nd dose), HEADACHE (Severe headache), MYALGIA (Severe muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at site of vaccine) and LYMPHADENOPATHY (Swollen lymph node under left arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1000 mg and IBUPROFEN ongoing since an unknown date at a dose of 600 mg. At the time of the report, ABDOMINAL PAIN UPPER (Little stomach upset), PAIN IN EXTREMITY (Arm pain), HEADACHE (Severe headache), MYALGIA (Severe muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), NAUSEA (Nausea), VACCINATION SITE SWELLING (Swelling at site of vaccine) and LYMPHADENOPATHY (Swollen lymph node under left arm) outcome was unknown and PYREXIA (Fever100.5 to 100.7 after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 100.5 (High) 100.5 F and 100.7 (High) 100.7 F. On 27-Jan-2021, Body temperature: 99 (Borderline) 99 F. On 23-Feb-2021, Hepatitis C antibody: 1.20 (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.   This case was linked to MOD-2021-051954.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: This Follow-up was received on 05-MAY-2021 which updated patient demographics.