chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Developed a cold; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Developed a cold) in a 63-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced NASOPHARYNGITIS (Developed a cold). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD) for Cold, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Developed a cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: NNI received
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Chills, Fatigue, Headache
Clinical narrative: Bone Pain; Weakness; Itchiness at injection Site; Chills; Fever; Muscle pain; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone Pain), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021 at 10:00 AM, 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 20-Apr-2021, the patient experienced BONE PAIN (Bone Pain), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Muscle pain), HEADACHE (Headache), FATIGUE (Tired) and VACCINATION SITE PRURITUS (Itchiness at injection Site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Bone Pain), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Muscle pain), HEADACHE (Headache), FATIGUE (Tired) and VACCINATION SITE PRURITUS (Itchiness at injection Site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR-NNI On 29-Jun-2021: TCR : AE outcome
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pruritus
Clinical narrative: Bone Pain; Weakness; Itchiness at injection Site; Chills; Fever; Muscle pain; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone Pain), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Muscle pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021 at 10:00 AM, 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 20-Apr-2021, the patient experienced BONE PAIN (Bone Pain), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Muscle pain), HEADACHE (Headache), FATIGUE (Tired) and VACCINATION SITE PRURITUS (Itchiness at injection Site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Bone Pain), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Muscle pain), HEADACHE (Headache), FATIGUE (Tired) and VACCINATION SITE PRURITUS (Itchiness at injection Site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR-NNI On 29-Jun-2021: TCR : AE outcome
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Bad fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Bad fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PREDNISONE and SULFAMETHOXAZOLE for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (Bad fever). At the time of the report, CHILLS (Chills) and PYREXIA (Bad fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  The patient's stated that his second vaccine appointment is on 18May2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Gait disturbance, Somnolence
Clinical narrative: Staggered to her car; Severe dizziness; Fell asleep; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Staggered to her car), DIZZINESS (Severe dizziness), SOMNOLENCE (Fell asleep) and FATIGUE (Tiredness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced GAIT DISTURBANCE (Staggered to her car), DIZZINESS (Severe dizziness), SOMNOLENCE (Fell asleep) and FATIGUE (Tiredness). At the time of the report, GAIT DISTURBANCE (Staggered to her car), DIZZINESS (Severe dizziness), SOMNOLENCE (Fell asleep) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was not provided by the reporter.  N o concomitant medications was provided by reported.   This case was linked to MOD-2021-092484 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Contusion, Dyspnoea, Headache
Clinical narrative: Red bruise circle size of a nickel on her left arm at the injection site; Little hard time breathing; Pain in the back of the neck; Middle of the chest is sore; Bruise on the chest and bruises on right upper arm; Red bruise circle size of a nickel on her left arm at the injection site; Chills; Pain at the injection site across the left shoulder; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Red bruise circle size of a nickel on her left arm at the injection site), DYSPNOEA (Little hard time breathing), NECK PAIN (Pain in the back of the neck), CHEST PAIN (Middle of the chest is sore) and CONTUSION (Bruise on the chest and bruises on right upper arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 24-Apr-2021, the patient experienced PYREXIA (Fever). On 25-Apr-2021, the patient experienced HEADACHE (Headache). On 26-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Red bruise circle size of a nickel on her left arm at the injection site), DYSPNOEA (Little hard time breathing), NECK PAIN (Pain in the back of the neck), CHEST PAIN (Middle of the chest is sore), CONTUSION (Bruise on the chest and bruises on right upper arm), VACCINATION SITE ERYTHEMA (Red bruise circle size of a nickel on her left arm at the injection site), CHILLS (Chills) and VACCINATION SITE PAIN (Pain at the injection site across the left shoulder). At the time of the report, VACCINATION SITE BRUISING (Red bruise circle size of a nickel on her left arm at the injection site), DYSPNOEA (Little hard time breathing), NECK PAIN (Pain in the back of the neck), CHEST PAIN (Middle of the chest is sore), CONTUSION (Bruise on the chest and bruises on right upper arm), VACCINATION SITE ERYTHEMA (Red bruise circle size of a nickel on her left arm at the injection site), CHILLS (Chills), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at the injection site across the left shoulder) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Vaccination site bruising, Vaccination site erythema, Vaccination site pain
Clinical narrative: Red bruise circle size of a nickel on her left arm at the injection site; Little hard time breathing; Pain in the back of the neck; Middle of the chest is sore; Bruise on the chest and bruises on right upper arm; Red bruise circle size of a nickel on her left arm at the injection site; Chills; Pain at the injection site across the left shoulder; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Red bruise circle size of a nickel on her left arm at the injection site), DYSPNOEA (Little hard time breathing), NECK PAIN (Pain in the back of the neck), CHEST PAIN (Middle of the chest is sore) and CONTUSION (Bruise on the chest and bruises on right upper arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 24-Apr-2021, the patient experienced PYREXIA (Fever). On 25-Apr-2021, the patient experienced HEADACHE (Headache). On 26-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Red bruise circle size of a nickel on her left arm at the injection site), DYSPNOEA (Little hard time breathing), NECK PAIN (Pain in the back of the neck), CHEST PAIN (Middle of the chest is sore), CONTUSION (Bruise on the chest and bruises on right upper arm), VACCINATION SITE ERYTHEMA (Red bruise circle size of a nickel on her left arm at the injection site), CHILLS (Chills) and VACCINATION SITE PAIN (Pain at the injection site across the left shoulder). At the time of the report, VACCINATION SITE BRUISING (Red bruise circle size of a nickel on her left arm at the injection site), DYSPNOEA (Little hard time breathing), NECK PAIN (Pain in the back of the neck), CHEST PAIN (Middle of the chest is sore), CONTUSION (Bruise on the chest and bruises on right upper arm), VACCINATION SITE ERYTHEMA (Red bruise circle size of a nickel on her left arm at the injection site), CHILLS (Chills), HEADACHE (Headache), VACCINATION SITE PAIN (Pain at the injection site across the left shoulder) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine that is in thefridge for more than 30 day / administration of expired vaccine that was on the counter for more than 100hours/ administration of expired vaccine that is in thefridge for more 30 day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine that is in thefridge for more than 30 day / administration of expired vaccine that was on the counter for more than 100hours/ administration of expired vaccine that is in thefridge for more 30 day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 27-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 EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine that is in thefridge for more than 30 day / administration of expired vaccine that was on the counter for more than 100hours/ administration of expired vaccine that is in thefridge for more 30 day). On 27-Apr-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine that is in thefridge for more than 30 day / administration of expired vaccine that was on the counter for more than 100hours/ administration of expired vaccine that is in thefridge for more 30 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up information received on 30-Apr-2021 contains non-significant information. On 10-May-2021: Follow-up information received on 10-May-2021 contains non-significant information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Product dose omission issue, Rash
Clinical narrative: Has not received her 2nd dose yet. (Day 39); Pain; Redness; Severe rash all over her body, the skin was bright red, painful, and felt like laying on a patch of thorns; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose yet. (Day 39)), PAIN (Pain), ERYTHEMA (Redness) and RASH (Severe rash all over her body, the skin was bright red, painful, and felt like laying on a patch of thorns) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL SULFATE (VENTOLIN [SALBUTAMOL SULFATE]), DULOXETINE HYDROCHLORIDE (CYMBALTA), TRAZODONE, ALPRAZOLAM (XANAX), METHADONE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), GABAPENTIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), CALCIUM, VITAMIN D3, MAGNESIUM, POTASSIUM and IRON for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (Pain), ERYTHEMA (Redness) and RASH (Severe rash all over her body, the skin was bright red, painful, and felt like laying on a patch of thorns). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose yet. (Day 39)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Rash, at an unspecified dose and frequency. On 12-Mar-2021, PAIN (Pain), ERYTHEMA (Redness) and RASH (Severe rash all over her body, the skin was bright red, painful, and felt like laying on a patch of thorns) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose yet. (Day 39)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product also include medical cannabis.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old patient received the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received the Moderna vaccine) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was no concomitant medications.  Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow-up information received on 31-may-2021 contains non-significant information. Reporter reported via mail that patient has no adverse reactions.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) 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 24-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: tired; Dizzy; lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), DIZZINESS (Dizzy) and DIZZINESS (lightheaded) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced FATIGUE (tired), DIZZINESS (Dizzy) and DIZZINESS (lightheaded). At the time of the report, FATIGUE (tired), DIZZINESS (Dizzy) and DIZZINESS (lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Lymphadenopathy, Myalgia, Pain in extremity, Somnolence
Clinical narrative: Pain in arm; Flu symptoms; Drowsiness; Muscle pain; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), INFLUENZA (Flu symptoms), SOMNOLENCE (Drowsiness), MYALGIA (Muscle pain) and LYMPHADENOPATHY (Swollen lymph nodes) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 032B21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), INFLUENZA (Flu symptoms), SOMNOLENCE (Drowsiness), MYALGIA (Muscle pain) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (Pain in arm), INFLUENZA (Flu symptoms), SOMNOLENCE (Drowsiness), MYALGIA (Muscle pain) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter.  No relevant treatment medication information provided.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 24 patients given Moderna vaccine after vials were refrozen; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (24 patients given Moderna vaccine after vials were refrozen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (24 patients given Moderna vaccine after vials were refrozen). At the time of the report, PRODUCT STORAGE ERROR (24 patients given Moderna vaccine after vials were refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Itching; Swollen left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen left arm) and PRURITUS (Itching) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen left arm). On 12-Apr-2021, the patient experienced PRURITUS (Itching). At the time of the report, PERIPHERAL SWELLING (Swollen left arm) and PRURITUS (Itching) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA higher than normal; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA higher than normal) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Previously administered products included for Prostate cancer: lupron injection (Patient took lupron injection for prostate cancer) on 07-Jan-2021.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 26-Apr-2021, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA higher than normal). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (PSA higher than normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Prostatic specific antigen: increased (High) Lupron shot normally brings Patient's PSA to around 0.8 and Patient went back today for next lupron injection and PSA was 1.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications were not provided by reporter.  Treatment medications were not given.   This case was linked to MOD-2021-020239 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: upper left arm redness the size of a dollar bill; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (upper left arm redness the size of a dollar bill) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, ATORVASTATIN, GABAPENTIN, CALCITRIOL and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ERYTHEMA (upper left arm redness the size of a dollar bill). At the time of the report, ERYTHEMA (upper left arm redness the size of a dollar bill) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment medication reported.   This case was linked to MOD-2021-092343 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: no new information updated.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergies; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (allergies) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included Disease risk factor (steroids and antihistamines).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergies). At the time of the report, HYPERSENSITIVITY (allergies) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported, treatment medication were not reported
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Chills; Headache; Fever 101F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 101F) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 101F). On 14-Apr-2021, CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 101F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 101 (High) fever 101F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Dysuria, Fatigue, Frequent bowel movements
Clinical narrative: Bowel movements acting weird, she goes several time a day; Urinating at night more often like once every hour; Urine with extreme urgency and burning sensation; Burning sensation in stomach after eating; Has some taste issues; Leg pain; Fatigue; Left Hip pain; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (Bowel movements acting weird, she goes several time a day), POLYURIA (Urinating at night more often like once every hour), DYSURIA (Urine with extreme urgency and burning sensation), ABDOMINAL DISCOMFORT (Burning sensation in stomach after eating) and TASTE DISORDER (Has some taste issues) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pain in arm since December 2020, Shoulder pain (Sometimes) since December 2020, Arthritis and Hemorrhoids.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 FREQUENT BOWEL MOVEMENTS (Bowel movements acting weird, she goes several time a day), POLYURIA (Urinating at night more often like once every hour), DYSURIA (Urine with extreme urgency and burning sensation), ABDOMINAL DISCOMFORT (Burning sensation in stomach after eating), TASTE DISORDER (Has some taste issues), PAIN IN EXTREMITY (Leg pain), FATIGUE (Fatigue) and ARTHRALGIA (Left Hip pain). At the time of the report, FREQUENT BOWEL MOVEMENTS (Bowel movements acting weird, she goes several time a day), POLYURIA (Urinating at night more often like once every hour), DYSURIA (Urine with extreme urgency and burning sensation), ABDOMINAL DISCOMFORT (Burning sensation in stomach after eating), TASTE DISORDER (Has some taste issues), PAIN IN EXTREMITY (Leg pain), FATIGUE (Fatigue) and ARTHRALGIA (Left Hip pain) outcome was unknown.            Concomitant products include Blood Pressure medication 40 mg, another one is 5 mg Treatment information includes Acetaminophen, Psyllium Action taken with mRNA-1273 in response to the events were not applicable.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Polyuria, Taste disorder
Clinical narrative: Bowel movements acting weird, she goes several time a day; Urinating at night more often like once every hour; Urine with extreme urgency and burning sensation; Burning sensation in stomach after eating; Has some taste issues; Leg pain; Fatigue; Left Hip pain; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (Bowel movements acting weird, she goes several time a day), POLYURIA (Urinating at night more often like once every hour), DYSURIA (Urine with extreme urgency and burning sensation), ABDOMINAL DISCOMFORT (Burning sensation in stomach after eating) and TASTE DISORDER (Has some taste issues) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pain in arm since December 2020, Shoulder pain (Sometimes) since December 2020, Arthritis and Hemorrhoids.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 FREQUENT BOWEL MOVEMENTS (Bowel movements acting weird, she goes several time a day), POLYURIA (Urinating at night more often like once every hour), DYSURIA (Urine with extreme urgency and burning sensation), ABDOMINAL DISCOMFORT (Burning sensation in stomach after eating), TASTE DISORDER (Has some taste issues), PAIN IN EXTREMITY (Leg pain), FATIGUE (Fatigue) and ARTHRALGIA (Left Hip pain). At the time of the report, FREQUENT BOWEL MOVEMENTS (Bowel movements acting weird, she goes several time a day), POLYURIA (Urinating at night more often like once every hour), DYSURIA (Urine with extreme urgency and burning sensation), ABDOMINAL DISCOMFORT (Burning sensation in stomach after eating), TASTE DISORDER (Has some taste issues), PAIN IN EXTREMITY (Leg pain), FATIGUE (Fatigue) and ARTHRALGIA (Left Hip pain) outcome was unknown.            Concomitant products include Blood Pressure medication 40 mg, another one is 5 mg Treatment information includes Acetaminophen, Psyllium Action taken with mRNA-1273 in response to the events were not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: excruciating pain in her arm and it seems to get more pronounced; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (excruciating pain in her arm and it seems to get more pronounced) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 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 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (excruciating pain in her arm and it seems to get more pronounced). At the time of the report, PAIN IN EXTREMITY (excruciating pain in her arm and it seems to get more pronounced) outcome was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Middle insomnia, Tremor
Clinical narrative: slight tremors; waking up in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (slight tremors) and MIDDLE INSOMNIA (waking up in the middle of the night) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Generalized anxiety disorder, Hypothyroidism and Insomnia disorder (The patient had trouble sleeping and waking up in the middle of the night.).    On 22-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 TREMOR (slight tremors) and MIDDLE INSOMNIA (waking up in the middle of the night). At the time of the report, TREMOR (slight tremors) and MIDDLE INSOMNIA (waking up in the middle of the night) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. The patient was taking Klonopin at night to relieve the symptoms.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Fatigue, Headache
Clinical narrative: Right arm red from arm to neck with a break in between, right arm redness between elbow and top of arm; Itching; Right arm being painful; Chills; Headache; Fatigue; Fever of 102.6 degrees for 24 hours/ low grade fever for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Right arm red from arm to neck with a break in between, right arm redness between elbow and top of arm), PRURITUS, MYALGIA (Right arm), CHILLS, and HEADACHE in a 91-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 was reported by the reporter.  Concomitant products included GABAPENTIN, ATORVASTATIN, METOPROLOL, CALCITRIOL, and ASPIRIN for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced ERYTHEMA (Right arm red from arm to neck with a break in between, right arm redness between elbow and top of arm), PRURITUS, MYALGIA (Right arm being painful), CHILLS, HEADACHE, FATIGUE, and PYREXIA (Fever of 102.6 degrees for 24 hours/ low grade fever for 24 hours). On 24-Apr-2021, PYREXIA (Fever of 102.6 degrees for 24 hours/ low grade fever for 24 hours) had resolved. At the time of the report, ERYTHEMA (Right arm red from arm to neck with a break in between, right arm redness between elbow and top of arm), PRURITUS, MYALGIA, CHILLS, HEADACHE, and FATIGUE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 102.6 (High) for 24 hours. On 23-Apr-2021, Heart rate: inconclusive.         Treatment information was not provided. Action taken with mRNA-1273 in response to the events is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14 Jun 2021 contains No new information.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Myalgia, Pruritus, Pyrexia
Clinical narrative: Right arm red from arm to neck with a break in between, right arm redness between elbow and top of arm; Itching; Right arm being painful; Chills; Headache; Fatigue; Fever of 102.6 degrees for 24 hours/ low grade fever for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Right arm red from arm to neck with a break in between, right arm redness between elbow and top of arm), PRURITUS, MYALGIA (Right arm), CHILLS, and HEADACHE in a 91-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 was reported by the reporter.  Concomitant products included GABAPENTIN, ATORVASTATIN, METOPROLOL, CALCITRIOL, and ASPIRIN for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced ERYTHEMA (Right arm red from arm to neck with a break in between, right arm redness between elbow and top of arm), PRURITUS, MYALGIA (Right arm being painful), CHILLS, HEADACHE, FATIGUE, and PYREXIA (Fever of 102.6 degrees for 24 hours/ low grade fever for 24 hours). On 24-Apr-2021, PYREXIA (Fever of 102.6 degrees for 24 hours/ low grade fever for 24 hours) had resolved. At the time of the report, ERYTHEMA (Right arm red from arm to neck with a break in between, right arm redness between elbow and top of arm), PRURITUS, MYALGIA, CHILLS, HEADACHE, and FATIGUE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 102.6 (High) for 24 hours. On 23-Apr-2021, Heart rate: inconclusive.         Treatment information was not provided. Action taken with mRNA-1273 in response to the events is not applicable   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14 Jun 2021 contains No new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm from both shots that lasted about a week; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm from both shots that lasted about a week) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis.    On 16-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 (soreness in the arm from both shots that lasted about a week). At the time of the report, PAIN IN EXTREMITY (soreness in the arm from both shots that lasted about a week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information reported.   This case was linked to MOD-2021-092360 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: rash; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and MYALGIA (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced RASH (rash) and MYALGIA (sore arm). At the time of the report, RASH (rash) and MYALGIA (sore arm) 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Pain in extremity, Speech disorder
Clinical narrative: bronchitis; coughing; couldn't talk; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (bronchitis), PAIN IN EXTREMITY (sore arm), COUGH (coughing) and SPEECH DISORDER (couldn't talk) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Mar-2021, the patient experienced BRONCHITIS (bronchitis). 31-Mar-2021, the patient experienced COUGH (coughing) and SPEECH DISORDER (couldn't talk). At the time of the report, BRONCHITIS (bronchitis), PAIN IN EXTREMITY (sore arm), COUGH (coughing) and SPEECH DISORDER (couldn't talk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details included antibiotics and steroids. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 2 weeks ago the customer tested positive for COVID; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (2 weeks ago the customer tested positive for COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (2 weeks ago the customer tested positive for COVID). At the time of the report, COVID-19 (2 weeks ago the customer tested positive for COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: Positive 2 weeks ago the customer tested positive for COVID, and a Few days later tested negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up contains non significant information. The reporter information was updated.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Depressed mood, Headache, Heart rate
Clinical narrative: sometimes gets stomach aches; she's not hungry; She's get down;not on a regular schedule and not living her normal life; first night everything was hurting / soreness in the arm from both shots that lasted about a week; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (sometimes gets stomach aches), DECREASED APPETITE (she's not hungry), DEPRESSED MOOD (She's get down;not on a regular schedule and not living her normal life), MYALGIA (first night everything was hurting / soreness in the arm from both shots that lasted about a week) and HEADACHE (Headaches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (sometimes gets stomach aches), DEPRESSED MOOD (She's get down;not on a regular schedule and not living her normal life), MYALGIA (first night everything was hurting / soreness in the arm from both shots that lasted about a week) and HEADACHE (Headaches). 15-Apr-2021, the patient experienced DECREASED APPETITE (she's not hungry). At the time of the report, ABDOMINAL PAIN UPPER (sometimes gets stomach aches), DECREASED APPETITE (she's not hungry), DEPRESSED MOOD (She's get down;not on a regular schedule and not living her normal life), MYALGIA (first night everything was hurting / soreness in the arm from both shots that lasted about a week) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Heart rate: 100 (High) 100.         Relevant concomitant medications were not reported.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-092344 (Patient Link).