chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Greater than 36 days separation between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 36 days separation between first and second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K28) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 36 days separation between first and second dose). On 26-Jan-2021, PRODUCT DOSE OMISSION ISSUE (Greater than 36 days separation between first and second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided. Reportedly, the patient received her first dose on 26-Jan-2021 but due to a number of factors, the patient couldn't follow up on her second vaccine until 07-Jun-2021.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count increased, Thrombocytosis
Clinical narrative: High platelet count; Thrombocytosis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLATELET COUNT INCREASED (High platelet count) and THROMBOCYTOSIS (Thrombocytosis) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 025l20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN+HCT) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced PLATELET COUNT INCREASED (High platelet count) and THROMBOCYTOSIS (Thrombocytosis). At the time of the report, PLATELET COUNT INCREASED (High platelet count) and THROMBOCYTOSIS (Thrombocytosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2014, Platelet count: 303 (Inconclusive) 303. In February 2016, Platelet count: 307 (Inconclusive) 307. In May 2021, Platelet count: 792 (Inconclusive) 792. In June 2021, Platelet count: 867 (Inconclusive) 867.         The patient consulted a Hematologist and was diagnosed with thrombocytosis.  The patient received both scheduled doses of mRNA-127 prior to the events, therefore action taken with the drug in response to the events as not applicable.  No treatment information was provided by the reporter.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Pyrexia
Clinical narrative: Very weak; high fever; She was in a bad way for a couple of hours; This spontaneous case was reported by a non-health professional and describes the occurrence of ASTHENIA (Very weak), FEELING ABNORMAL (She was in a bad way for a couple of hours) and PYREXIA (high fever) in an 84-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Very weak), FEELING ABNORMAL (She was in a bad way for a couple of hours) and PYREXIA (high fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, ASTHENIA (Very weak), FEELING ABNORMAL (She was in a bad way for a couple of hours) and PYREXIA (high fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Nausea, Vomiting
Clinical narrative: nauseated; vomiting anytime she attempted to eat a meal; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (nauseated) and VOMITING (vomiting anytime she attempted to eat a meal) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Diabetes and Thyroid disorder NOS.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 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 NAUSEA (nauseated) and VOMITING (vomiting anytime she attempted to eat a meal). At the time of the report, NAUSEA (nauseated) and VOMITING (vomiting anytime she attempted to eat a meal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 10 (High) elevated blood sugars of "10".     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The patient visited her primary care physician and was prescribed unspecified additional medication for the elevated blood sugar.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Sore left arm; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore left arm) and FATIGUE (Tiredness) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BENAZEPRIL and IRON for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced MYALGIA (Sore left arm) and FATIGUE (Tiredness). At the time of the report, MYALGIA (Sore left arm) and FATIGUE (Tiredness) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Malaise
Clinical narrative: Feeling sick after the Modena vaccine; Stomachache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Stomachache) and MALAISE (Feeling sick after the Modena vaccine) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN UPPER (Stomachache). On an unknown date, the patient experienced MALAISE (Feeling sick after the Modena vaccine). At the time of the report, ABDOMINAL PAIN UPPER (Stomachache) and MALAISE (Feeling sick after the Modena vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  After 2-3 weeks of vaccination patient experienced stomachache, patient thought this was indigestion or pancreatitis. Patient contacted doctor online. Patient's condition aggravated after second dose and died on 05-Jun-2021.  No treatment was provided.  Action taken with mRNA-1273 in response to the events was not Applicable.    This case was linked to MOD-2021-211616 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up information received on  07-May-2021 had a new event feeling sick after the Modena vaccine was added to the case.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: prolonged joint pain; prolonged muscle pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (prolonged joint pain) and MYALGIA (prolonged muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (prolonged joint pain) and MYALGIA (prolonged muscle pain). At the time of the report, ARTHRALGIA (prolonged joint pain) and MYALGIA (prolonged muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Macule, Rash
Clinical narrative: Red spot right buttock, right wrist, both ankles, left elbow; Rash left arm and shoulder; This spontaneous case was reported by a nurse and describes the occurrence of MACULE (Red spot right buttock, right wrist, both ankles, left elbow) and RASH (Rash left arm and shoulder) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), PREDNISONE, POTASSIUM and LOSARTAN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced MACULE (Red spot right buttock, right wrist, both ankles, left elbow) and RASH (Rash left arm and shoulder). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, MACULE (Red spot right buttock, right wrist, both ankles, left elbow) and RASH (Rash left arm and shoulder) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-211568 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Prolonged joint pain; prolonged muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Prolonged joint pain) and MYALGIA (prolonged muscle pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Prolonged joint pain) and MYALGIA (prolonged muscle pain). At the time of the report, ARTHRALGIA (Prolonged joint pain) and MYALGIA (prolonged muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Reaction at the site of my injection (noticeable almost immediately upon injection); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction at the site of my injection (noticeable almost immediately upon injection)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Reaction at the site of my injection (noticeable almost immediately upon injection)). At the time of the report, VACCINATION SITE REACTION (Reaction at the site of my injection (noticeable almost immediately upon injection)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Prolonged joint pain; Prolonged muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Prolonged joint pain) and MYALGIA (Prolonged muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ARTHRALGIA (Prolonged joint pain) and MYALGIA (Prolonged muscle pain). At the time of the report, ARTHRALGIA (Prolonged joint pain) and MYALGIA (Prolonged muscle pain) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020, Clot blood (in left arm since the pacemaker implantation) and Pacemaker insertion (cardiac) (pacemaker/defibrillator). Concurrent medical conditions included COPD and Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), UMECLIDINIUM BROMIDE (INCRUSE), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), APIXABAN (ELIQUIS) and LEVOTHYROXINE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FATIGUE (tired). On 07-Mar-2021, FATIGUE (tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient reported no known allergies. No treatment information was provided by the reporter.   This case was linked to MOD-2021-211604, MOD-2021-211687 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non-significant followup
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Paraesthesia
Clinical narrative: my right arm gets a tingling feeling that I have not had before; just has this weird feeling/ At times this feeling spreads up the side of my neck/ This feeling comes and goes/ like when your foot, arm, etc goes to sleep; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (my right arm gets a tingling feeling that I have not had before) and FEELING ABNORMAL (just has this weird feeling/ At times this feeling spreads up the side of my neck/ This feeling comes and goes/ like when your foot, arm, etc goes to sleep) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (my right arm gets a tingling feeling that I have not had before) and FEELING ABNORMAL (just has this weird feeling/ At times this feeling spreads up the side of my neck/ This feeling comes and goes/ like when your foot, arm, etc goes to sleep). At the time of the report, PARAESTHESIA (my right arm gets a tingling feeling that I have not had before) and FEELING ABNORMAL (just has this weird feeling/ At times this feeling spreads up the side of my neck/ This feeling comes and goes/ like when your foot, arm, etc goes to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Prolonged muscle pain; Prolonged joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Prolonged muscle pain) and ARTHRALGIA (Prolonged joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 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 MYALGIA (Prolonged muscle pain) and ARTHRALGIA (Prolonged joint pain). At the time of the report, MYALGIA (Prolonged muscle pain) and ARTHRALGIA (Prolonged joint pain) outcome was unknown.            Concomitant product was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: Really bad pain; Can't lift my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Really bad pain) and MOBILITY DECREASED (Can't lift my arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Really bad pain) and MOBILITY DECREASED (Can't lift my arm). At the time of the report, PAIN (Really bad pain) and MOBILITY DECREASED (Can't lift my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.    Reporter did not allow further contact
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours; patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours) and PRODUCT STORAGE ERROR (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours). On 05-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours) had resolved. At the time of the report, PRODUCT STORAGE ERROR (patient got the second dose  from a vial  that was punctured and out of storage conditions for 17 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  Reportedly, the patient reported no side effects up to the time of reporting.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Only symptom noted with the first dose was a sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Only symptom noted with the first dose was a sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 039B21A) for COVID-19 vaccination.     No Medical history was reported.  Concomitant products included WARFARIN, ONDANSETRON, BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), SUMATRIPTAN, CELECOXIB (CELEXA [CELECOXIB]), ETHINYLESTRADIOL, ETONOGESTREL (NUVARING) and BACLOFEN for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-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 VACCINATION SITE PAIN (Only symptom noted with the first dose was a sore arm). At the time of the report, VACCINATION SITE PAIN (Only symptom noted with the first dose was a sore arm) outcome was unknown. Not Provided          Treatment information was not provided.   This case was linked to MOD-2021-211542 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Headache
Clinical narrative: headache; high inflammation maker; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache) and C-REACTIVE PROTEIN INCREASED (high inflammation maker) 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 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and C-REACTIVE PROTEIN INCREASED (high inflammation maker). At the time of the report, HEADACHE (headache) had resolved and C-REACTIVE PROTEIN INCREASED (high inflammation maker) had not resolved. Not Provided          No Concomitant medications were reported.  Treatment medications taken were steroids.  Patient had appointment with a rheumatologist.    Action taken with mRNA-1273 in response to the events were Not Applicable.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: a few red spots; red itchy spots all over their body; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (a few red spots) and PRURITUS (red itchy spots all over their body) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 081P021A) for COVID-19 vaccination.     Concomitant products included ATENOLOL for Blood pressure.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (a few red spots) and PRURITUS (red itchy spots all over their body). The patient was treated with PERMETHRIN at a dose of 1 dosage form and PREDNISONE at a dose of 10 mg. At the time of the report, ERYTHEMA (a few red spots) and PRURITUS (red itchy spots all over their body) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events were Not Applicable.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Passed the 42 days recommended interval for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed the 42 days recommended interval for second dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed the 42 days recommended interval for second dose). On 28-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Passed the 42 days recommended interval for second dose) had resolved.            No relevant concomitant medications were provided. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Skin irritation, Vaccination site haemorrhage
Clinical narrative: blood at the injection site; joint pain; Skin irritation; mild arm soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Apr-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of SKIN IRRITATION (Skin irritation), MYALGIA (mild arm soreness), VACCINATION SITE HAEMORRHAGE (blood at the injection site) and ARTHRALGIA (joint pain) 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 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced SKIN IRRITATION (Skin irritation) and MYALGIA (mild arm soreness). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (blood at the injection site) and ARTHRALGIA (joint pain). At the time of the report, SKIN IRRITATION (Skin irritation), MYALGIA (mild arm soreness), VACCINATION SITE HAEMORRHAGE (blood at the injection site) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided          No concomitant and treatment medications were provided.  Action taken with mRNA-1273 in response to the events were Not Applicable.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Soreness in my shoulder; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Soreness in my shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement. Concurrent medical conditions included Hypercholesterolemia. Concomitant products included ATORVASTATIN for Hypercholesterolemia, CLOPIDOGREL for Stent placement, LISINOPRIL and METOPROLOL for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ARTHRALGIA (Soreness in my shoulder). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency and MENTHOL, METHYL SALICYLATE (ARTHRITIS HOT) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Soreness in my shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-211636 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Discomfort, Dyspnoea
Clinical narrative: Severe Asthma; Uncomfortable; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Shortness of breath), ASTHMA (Severe Asthma) and DISCOMFORT (Uncomfortable) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DYSPNEA (Shortness of breath) and DISCOMFORT (Uncomfortable). On 29-Mar-2021, the patient experienced ASTHMA (Severe Asthma). At the time of the report, DYSPNEA (Shortness of breath), ASTHMA (Severe Asthma) and DISCOMFORT (Uncomfortable) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications include Asthma medication.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Updated outcome of event Shortness of breath, Asthma, Discomfort from Unknown to Recovered.
Sex: U
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: tooth infection; This spontaneous case was reported by a pharmacist and describes the occurrence of TOOTH INFECTION (tooth infection) 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 TOOTH INFECTION (tooth infection). At the time of the report, TOOTH INFECTION (tooth infection) 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.   The concomitant medications were not provided. the Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Inconsistent Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Inconsistent Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 009C21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included METOPROLOL and AMLODIPINE for Hypertension, COLECALCIFEROL (VIT D [COLECALCIFEROL]), ASCORBIC ACID (VIT C) and MULTIVITAMIN [VITAMINS NOS] for Supplementation therapy, LORAZEPAM for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DIZZINESS (Inconsistent Dizziness). The patient was treated with MECLIZINE HCL ongoing since an unknown date for Adverse event, at a dose of 25 milligram. At the time of the report, DIZZINESS (Inconsistent Dizziness) outcome was unknown. Not Provided          The action taken with mRNA-1273 with the event was considered as not applicable.   This case was linked to MOD-2021-237493 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Non significant follow up received; action taken changed to Not applicable., generated the narrative
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: Feeling strange, kind of weird; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling strange, kind of weird), FATIGUE (Tiredness) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced FEELING ABNORMAL (Feeling strange, kind of weird), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Feeling strange, kind of weird) and FATIGUE (Tiredness) outcome was unknown and HEADACHE (Headache) had resolved.            No concomitant medication were reported.  Patient  said that every evening around supper time he start feeling strange, kind of weird. He used to drink half a quart of water and eat and then felt good after 30min. He had headache earlier but that went away after a day or two.   No additional  treatment information was reported.   This case was linked to MOD-2021-089530 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and Treatment medication were reported.    This case was linked to MOD-2021-211633 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of pain in extremity (arm soreness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013L20A and 010M20A) for COVID-19 immunization. Concurrent medical conditions included herpes (NOS), keratosis and iodine allergy. Concomitant products included Valtrex (valaciclovir hydrochloride) for herpes (NOS), Flexura (metaxalone) for muscle relaxant. On Jan 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 10, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 13, 2021, patient experienced pain in extremity (arm soreness). On Jan 16, 2021, pain in extremity (arm soreness) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. After 6 weeks, patient noticed her keratosis (skin cancer) faded and completely gone with 70% improvement. No treatment medications reported.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Mild dizziness; being tired; headaches; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Mild dizziness), FATIGUE (being tired) and HEADACHE (headaches) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included BISOPROLOL, CALCIUM and RISEDRONATE SODIUM (RISEDRONATE) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Mild dizziness), FATIGUE (being tired) and HEADACHE (headaches). In February 2021, DIZZINESS (Mild dizziness), FATIGUE (being tired) and HEADACHE (headaches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient experienced mild dizziness and headaches that would last a minute and disappear and recur in a few hours. This lasted for a week and half. The patient also reported being tired which lasted for two and a half weeks.  No treatment details were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Therapeutic response unexpected
Clinical narrative: Arm soreness; Headache; Fatigue; Keratosis (Skin Cancer) are faded and completely gone; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm soreness), HEADACHE (Headache), FATIGUE (Fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Keratosis (Skin Cancer) are faded and completely gone) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Keratosis. Concurrent medical conditions included Iodine allergy. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes dermatitis, CYCLOBENZAPRINE for Muscle relaxant.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 12-Feb-2021, the patient experienced MYALGIA (Arm soreness), HEADACHE (Headache), FATIGUE (Fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Keratosis (Skin Cancer) are faded and completely gone). At the time of the report, MYALGIA (Arm soreness), HEADACHE (Headache), FATIGUE (Fatigue) and THERAPEUTIC RESPONSE UNEXPECTED (Keratosis (Skin Cancer) are faded and completely gone) outcome was unknown. Not Provided          treatment to the events not provided. Keratosis (Skin Cancer) are faded and completely gone with 70% improvement.  Action taken with mRNA-1273 in response to the event was not applicable
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: First shot arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (First shot arm pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    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 MYALGIA (First shot arm pain). On 15-Mar-2021, MYALGIA (First shot arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported .
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 17-Apr-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 102 f (High) Fever of 102 F.         No concomitant medication provided.   This case was linked to MOD-2021-211623 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Product dose omission issue
Clinical narrative: Delay of 2nd Moderna Vaccination past 42 days; severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Delay of 2nd Moderna Vaccination past 42 days) and FATIGUE (severe fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Stroke (had 2 strokes). Concurrent medical conditions included Allergy to antibiotic (Azithromycin), Allergy to antibiotic (Ciprofloxacin), Cerebral palsy, Wheelchair user (very fragile, very thin), Blood pressure high, Diabetes and Hypolipidemia. Concomitant products included INSULIN for an unknown indication.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced FATIGUE (severe fatigue). On 07-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Delay of 2nd Moderna Vaccination past 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Delay of 2nd Moderna Vaccination past 42 days) had resolved and FATIGUE (severe fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included High Blood Pressure Medication, Hypolipidemic Medication and Oral Antidiabetic Medication for an unknown indication.  It was reported that the patient was very fragile and very thin. He developed sever fatigues after first dose of vaccine and couldn't get out of the car. on 28-Apr-2021, the patient's second vaccination was due but they couldn't get the patient in car.  No treatment information was provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received first dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received first dose of Moderna COVID-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received first dose of Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received first dose of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications and No Treatment medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Pain
Clinical narrative: soreness in my shoulder/right hand started experiencing a lot of pain in the joints; shoulder and hand throbbing and it keeps me up; The soreness didn't go away and has gotten worse over time; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (soreness in my shoulder/right hand started experiencing a lot of pain in the joints), PAIN (shoulder and hand throbbing and it keeps me up) and CONDITION AGGRAVATED (The soreness didn't go away and has gotten worse over time) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 038K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for Cholesterol, CLOPIDOGREL for Stent placement, LISINOPRIL and METOPROLOL for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced ARTHRALGIA (soreness in my shoulder/right hand started experiencing a lot of pain in the joints), PAIN (shoulder and hand throbbing and it keeps me up) and CONDITION AGGRAVATED (The soreness didn't go away and has gotten worse over time). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (soreness in my shoulder/right hand started experiencing a lot of pain in the joints), PAIN (shoulder and hand throbbing and it keeps me up) and CONDITION AGGRAVATED (The soreness didn't go away and has gotten worse over time) had not resolved.            Treatment information also include Arthritis HOT Ointment.  The soreness didn't go away and has gotten worse over time. Their right hand also started experiencing a lot of pain in the joints. The patient waited and thought it would subside but hasn't yet. The soreness really bothers them more at night compared to any other time when they have a lot of movement. When they lay on their left side at night and their right side is elevated, their shoulder and hand begin throbbing and keeps them up.   This case was linked to MOD-2021-211615 (Patient Link).