chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Red, itchy sore swollen injection site bump; Red, itchy sore swollen injection site bump; Red, itchy sore swollen injection site bump; Red, itchy sore swollen injection site bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red, itchy sore swollen injection site bump), VACCINATION SITE PRURITUS (Red, itchy sore swollen injection site bump), VACCINATION SITE SWELLING (Red, itchy sore swollen injection site bump) and VACCINATION SITE PAIN (Red, itchy sore swollen injection site bump) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red, itchy sore swollen injection site bump), VACCINATION SITE PRURITUS (Red, itchy sore swollen injection site bump), VACCINATION SITE SWELLING (Red, itchy sore swollen injection site bump) and VACCINATION SITE PAIN (Red, itchy sore swollen injection site bump). At the time of the report, VACCINATION SITE ERYTHEMA (Red, itchy sore swollen injection site bump), VACCINATION SITE PRURITUS (Red, itchy sore swollen injection site bump), VACCINATION SITE SWELLING (Red, itchy sore swollen injection site bump) and VACCINATION SITE PAIN (Red, itchy sore swollen injection site bump) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment included over the counter topical antibiotic ointment.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected counterfeit product
Clinical narrative: Tested negative for antibodies; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Tested negative for antibodies) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Tested negative for antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (Tested negative for antibodies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment information was not provided. Company comment:  Based on the known information of the vaccine, post-vaccination antibody test results will be negative in individuals without a history of previous natural infection if the test used does not detect the type of antibodies induced by the vaccine. This can be natural and thus assessed as not related to the vaccine.; Sender's Comments: Based on the known information of the vaccine, post-vaccination antibody test results will be negative in individuals without a history of previous natural infection if the test used does not detect the type of antibodies induced by the vaccine. This can be natural and thus assessed as not related to the vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Illness, Nausea
Clinical narrative: sicker than a dog for over a week with Moderna; injection site is also very hot; injection site has a red spot; injection site is also very hot, very red, and itches; swollen like a super man arm" and the injection site has a red spot; fatigue; headaches; joint pain; nausea.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sicker than a dog for over a week with Moderna), VACCINATION SITE WARMTH (injection site is also very hot), VACCINATION SITE ERYTHEMA (injection site has a red spot), VACCINATION SITE PRURITUS (injection site is also very hot, very red, and itches) and VACCINATION SITE SWELLING (swollen like a super man arm" and the injection site has a red spot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sicker than a dog for over a week with Moderna), VACCINATION SITE WARMTH (injection site is also very hot), VACCINATION SITE ERYTHEMA (injection site has a red spot), VACCINATION SITE PRURITUS (injection site is also very hot, very red, and itches), VACCINATION SITE SWELLING (swollen like a super man arm" and the injection site has a red spot), FATIGUE (fatigue), HEADACHE (headaches), ARTHRALGIA (joint pain) and NAUSEA (nausea.). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, ILLNESS (sicker than a dog for over a week with Moderna), VACCINATION SITE WARMTH (injection site is also very hot), VACCINATION SITE ERYTHEMA (injection site has a red spot), VACCINATION SITE PRURITUS (injection site is also very hot, very red, and itches), VACCINATION SITE SWELLING (swollen like a super man arm" and the injection site has a red spot), FATIGUE (fatigue), HEADACHE (headaches), ARTHRALGIA (joint pain) and NAUSEA (nausea.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up report received on 05-Aug-2021, Added event (sicker than a dog with Moderna).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: sicker than a dog for over a week with Moderna; injection site is also very hot; injection site has a red spot; injection site is also very hot, very red, and itches; swollen like a super man arm" and the injection site has a red spot; fatigue; headaches; joint pain; nausea.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sicker than a dog for over a week with Moderna), VACCINATION SITE WARMTH (injection site is also very hot), VACCINATION SITE ERYTHEMA (injection site has a red spot), VACCINATION SITE PRURITUS (injection site is also very hot, very red, and itches) and VACCINATION SITE SWELLING (swollen like a super man arm" and the injection site has a red spot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sicker than a dog for over a week with Moderna), VACCINATION SITE WARMTH (injection site is also very hot), VACCINATION SITE ERYTHEMA (injection site has a red spot), VACCINATION SITE PRURITUS (injection site is also very hot, very red, and itches), VACCINATION SITE SWELLING (swollen like a super man arm" and the injection site has a red spot), FATIGUE (fatigue), HEADACHE (headaches), ARTHRALGIA (joint pain) and NAUSEA (nausea.). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, ILLNESS (sicker than a dog for over a week with Moderna), VACCINATION SITE WARMTH (injection site is also very hot), VACCINATION SITE ERYTHEMA (injection site has a red spot), VACCINATION SITE PRURITUS (injection site is also very hot, very red, and itches), VACCINATION SITE SWELLING (swollen like a super man arm" and the injection site has a red spot), FATIGUE (fatigue), HEADACHE (headaches), ARTHRALGIA (joint pain) and NAUSEA (nausea.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up report received on 05-Aug-2021, Added event (sicker than a dog with Moderna).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Migraine, Palpitations
Clinical narrative: heart palpitations; Severe migraine; can not function; totally wiped out with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations), MIGRAINE (Severe migraine), IMPAIRED WORK ABILITY (can not function) and FATIGUE (totally wiped out with fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PALPITATIONS (heart palpitations), MIGRAINE (Severe migraine), IMPAIRED WORK ABILITY (can not function) and FATIGUE (totally wiped out with fatigue). At the time of the report, PALPITATIONS (heart palpitations), MIGRAINE (Severe migraine), IMPAIRED WORK ABILITY (can not function) and FATIGUE (totally wiped out with fatigue) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Infection, Lymphadenopathy, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (still has pain in left arm), INFECTION (He was given medication for infection), LYMPHADENOPATHY (lymph nodes in both arms are swollen) and ARTHRALGIA (pain at the end of the arm, wrist and thumb) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 030L20K) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (still has pain in left arm) and LYMPHADENOPATHY (lymph nodes in both arms are swollen). On an unknown date, the patient experienced INFECTION (He was given medication for infection) and ARTHRALGIA (pain at the end of the arm, wrist and thumb). At the time of the report, PAIN IN EXTREMITY (still has pain in left arm) and LYMPHADENOPATHY (lymph nodes in both arms are swollen) had not resolved and INFECTION (He was given medication for infection) and ARTHRALGIA (pain at the end of the arm, wrist and thumb) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable.  Treatment medication included a cream for the pain. No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-072642 (E2B Linked Report). This case was linked to MOD-2021-072642 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 10-MAY-2021 contains Event added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072642:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site rash
Clinical narrative: AE start date update (lump); AE start date update (rash); AE start date update (pain); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (AE start date update (lump)), VACCINATION SITE RASH (AE start date update (rash)) and VACCINATION SITE PAIN (AE start date update (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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE MASS (AE start date update (lump)), VACCINATION SITE RASH (AE start date update (rash)) and VACCINATION SITE PAIN (AE start date update (pain)). At the time of the report, VACCINATION SITE MASS (AE start date update (lump)), VACCINATION SITE RASH (AE start date update (rash)) and VACCINATION SITE PAIN (AE start date update (pain)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: Sore Throat; Chills; Headache; Fever of 101.7; Arm Hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Hurting), OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.7) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm Hurting). On 09-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.7). At the time of the report, PAIN IN EXTREMITY (Arm Hurting), OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.7) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore Throat; Chills; Headache; Fever of 101.7; Arm Hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Hurting), OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.7) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm Hurting). On 09-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.7). At the time of the report, PAIN IN EXTREMITY (Arm Hurting), OROPHARYNGEAL PAIN (Sore Throat), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever of 101.7) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pruritus
Clinical narrative: Pink patch on the injection site; Nasty itch on the left arm/ itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Nasty itch on the left arm/ itching) and VACCINATION SITE DISCOLOURATION (Pink patch on the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Nasty itch on the left arm/ itching). On 10-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pink patch on the injection site). At the time of the report, VACCINATION SITE PRURITUS (Nasty itch on the left arm/ itching) and VACCINATION SITE DISCOLOURATION (Pink patch on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-05-2021:Outcome of the events updated.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Scratch, Skin swelling, Urticaria
Clinical narrative: Hives; Bumps that are itchy; Itchiness; scratches to the point where it becomes swollen and one big 5 centimeter hive; lips (top & bottoms) have also started to swell; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), SKIN SWELLING (Bumps that are itchy), PRURITUS (Itchiness), SCRATCH (scratches to the point where it becomes swollen and one big 5 centimeter hive) and LIP SWELLING (lips (top & bottoms) have also started to swell) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced URTICARIA (Hives), SKIN SWELLING (Bumps that are itchy), PRURITUS (Itchiness), SCRATCH (scratches to the point where it becomes swollen and one big 5 centimeter hive) and LIP SWELLING (lips (top & bottoms) have also started to swell). At the time of the report, URTICARIA (Hives), SKIN SWELLING (Bumps that are itchy), PRURITUS (Itchiness), SCRATCH (scratches to the point where it becomes swollen and one big 5 centimeter hive) and LIP SWELLING (lips (top & bottoms) have also started to swell) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment included as Benadryl.   This case was linked to MOD-2021-072643 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site mass
Clinical narrative: a lumpy ball that got sore; a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a lumpy ball that got sore) and PAIN IN EXTREMITY (a little bit of a sore arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE MASS (a lumpy ball that got sore) and PAIN IN EXTREMITY (a little bit of a sore arm). At the time of the report, VACCINATION SITE MASS (a lumpy ball that got sore) and PAIN IN EXTREMITY (a little bit of a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: still has pain in left arm; lymph nodes in both arms are swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (still has pain in left arm) and LYMPHADENOPATHY (lymph nodes in both arms are swollen) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20K) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high (high blood pressure).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (still has pain in left arm) and LYMPHADENOPATHY (lymph nodes in both arms are swollen). At the time of the report, PAIN IN EXTREMITY (still has pain in left arm) and LYMPHADENOPATHY (lymph nodes in both arms are swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information includes medication (unknown), and a cream for the pain.  No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-072636 (E2B Linked Report). This case was linked to MOD-2021-072636 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information received on 07-May-2021 added event details, treatment information and dose 2 details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072636:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face is swollen today) and SWELLING (happen on legs, belly area and back but as of recent, it happens everywhere) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced SWELLING FACE (face is swollen today) and SWELLING (happen on legs, belly area and back but as of recent, it happens everywhere). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (face is swollen today) and SWELLING (happen on legs, belly area and back but as of recent, it happens everywhere) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment included Benadryl. The patient stated that she took allergy medicine as her face was swollen. Action taken with mRNA-1273 in response to events was not applicable. This case was linked to MOD-2021-072640.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Hypertension, Mobility decreased
Clinical narrative: Hypertension; High blood pressure condition has worsened; Weakness; Difficulty to move at night; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Hypertension), CONDITION AGGRAVATED (High blood pressure condition has worsened), ASTHENIA (Weakness) and MOBILITY DECREASED (Difficulty to move at night) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Parkinson's disease.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-1900, the patient experienced MOBILITY DECREASED (Difficulty to move at night). On 04-Feb-2021, the patient experienced HYPERTENSION (Hypertension), CONDITION AGGRAVATED (High blood pressure condition has worsened) and ASTHENIA (Weakness). At the time of the report, HYPERTENSION (Hypertension), CONDITION AGGRAVATED (High blood pressure condition has worsened), ASTHENIA (Weakness) and MOBILITY DECREASED (Difficulty to move at night) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Injection site swelling, Pain, Pyrexia
Clinical narrative: slight fever; overall flu-like symptoms; aches; feeling tired; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling at injection site), PYREXIA (slight fever), INFLUENZA LIKE ILLNESS (overall flu-like symptoms), PAIN (aches) and FATIGUE (feeling tired) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-Apr-2021, the patient experienced INJECTION SITE SWELLING (swelling at injection site). On 07-Apr-2021, the patient experienced PYREXIA (slight fever), INFLUENZA LIKE ILLNESS (overall flu-like symptoms), PAIN (aches) and FATIGUE (feeling tired). At the time of the report, INJECTION SITE SWELLING (swelling at injection site), PYREXIA (slight fever), INFLUENZA LIKE ILLNESS (overall flu-like symptoms), PAIN (aches) and FATIGUE (feeling tired) outcome was unknown. Not Provided          Action taken was not applicable.  No treatment and concomitant medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Swelling face
Clinical narrative: Face swollen; little pain under neck area; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swollen) and NECK PAIN (little pain under neck area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038921A and 031132A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced SWELLING FACE (Face swollen) and NECK PAIN (little pain under neck area). At the time of the report, SWELLING FACE (Face swollen) and NECK PAIN (little pain under neck area) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Feeling hot
Clinical narrative: The shot caused a reaction to her medication; Feeling hot all over the body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Feeling hot all over the body) and ADVERSE REACTION (The shot caused a reaction to her medication) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M204) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included DOXEPINE, FOSINOPRIL, AMLODIPINE, TIMOLOL and PREDNISOLONE for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced FEELING HOT (Feeling hot all over the body). On an unknown date, the patient experienced ADVERSE REACTION (The shot caused a reaction to her medication). At the time of the report, FEELING HOT (Feeling hot all over the body) and ADVERSE REACTION (The shot caused a reaction to her medication) outcome was unknown.            Treatment medication were not reported.  Follow up received on 02-Aug-2021. the patient did not have an email or fax, She asked if the forms could be mailed to her. She also stated that the shot caused a reaction to her medication.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant Follow up received on 02-Aug-2021. Event, "Shot caused reaction to her medication" was added. Updated contact details.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product dose omission issue
Clinical narrative: Passed the 42 day mark to receive the second dose; Second dose given more than 35 days after first dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed the 42 day mark to receive the second dose) and OFF LABEL USE (Second dose given more than 35 days after first dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no recorder medical history).   On 26-Jan-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed the 42 day mark to receive the second dose) and OFF LABEL USE (Second dose given more than 35 days after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed the 42 day mark to receive the second dose) had resolved and OFF LABEL USE (Second dose given more than 35 days after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was in an adult rehab center and didn't receive his second dose yet. It is passed the 42 day mark to receive the second dose. Treatment medication was not provided.  The patient took second dose more than 35 days after first dose.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Patient details updated, add additional event (off label dosing frequency), updated dosage regimen
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: extremely severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (extremely severe headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (extremely severe headache). At the time of the report, HEADACHE (extremely severe headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Vaccination site pain
Clinical narrative: Stomach pain, massive really bad stomach cramps; Injection arm sore; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain, massive really bad stomach cramps) and VACCINATION SITE PAIN (Injection arm sore) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain, massive really bad stomach cramps) and VACCINATION SITE PAIN (Injection arm sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain, massive really bad stomach cramps) and VACCINATION SITE PAIN (Injection arm sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: She's having she doesn't know if it is cold or allergies; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (She's having she doesn't know if it is cold or allergies) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 HYPERSENSITIVITY (She's having she doesn't know if it is cold or allergies). At the time of the report, HYPERSENSITIVITY (She's having she doesn't know if it is cold or allergies) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient does not know if it was cold or allergies, she was due for her second dose tomorrow(at a time of report), both work at school in the medical field.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Reporter details and suspect drug dosage details for second dose were updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise the size of a half dollar at the injection site), VACCINATION SITE HAEMORRHAGE (bleeding at the injection site when the needle was withdrawn), VACCINATION SITE SWELLING (swelling at the injection site), FATIGUE (fatigue) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]) for an unknown indication. 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 07-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at the injection site when the needle was withdrawn), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). On 08-Apr-2021, the patient experienced VACCINATION SITE BRUISING (bruise the size of a half dollar at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE BRUISING (bruise the size of a half dollar at the injection site), VACCINATION SITE HAEMORRHAGE (bleeding at the injection site when the needle was withdrawn), VACCINATION SITE SWELLING (swelling at the injection site), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received on 23-Jun-2021 and contains no new information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruise the size of a half dollar at the injection site), VACCINATION SITE HAEMORRHAGE (bleeding at the injection site when the needle was withdrawn), VACCINATION SITE SWELLING (swelling at the injection site), FATIGUE (fatigue) and PYREXIA (fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]) for an unknown indication. 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 07-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at the injection site when the needle was withdrawn), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). On 08-Apr-2021, the patient experienced VACCINATION SITE BRUISING (bruise the size of a half dollar at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE BRUISING (bruise the size of a half dollar at the injection site), VACCINATION SITE HAEMORRHAGE (bleeding at the injection site when the needle was withdrawn), VACCINATION SITE SWELLING (swelling at the injection site), FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received on 23-Jun-2021 and contains no new information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain in armpits; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain in armpits) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-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) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN (Pain in armpits). At the time of the report, PAIN (Pain in armpits) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: bad reaction; 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 SITE REACTION (bad reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 (bad reaction). At the time of the report, VACCINATION SITE REACTION (bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This case concerns an adult patient of unknown age and gender with a serious unexpected event of vaccination site reaction. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on 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.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity
Clinical narrative: Sore arm; Received her second dose of vaccine 43 hours earlier; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and OFF LABEL USE (Received her second dose of vaccine 43 hours earlier) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and OFF LABEL USE (Received her second dose of vaccine 43 hours earlier). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and OFF LABEL USE (Received her second dose of vaccine 43 hours earlier) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-073957 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: Cold hands; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PERIPHERAL COLDNESS. On 04-Mar-2021, PERIPHERAL COLDNESS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-072679. Sender's Comments MOD-2021-072679: Second dose of vaccine case.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: fever; chills; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain). At the time of the report, PYREXIA (fever), CHILLS (chills) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak) and VOMITING (Vomiting for 12 hours) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2020, the patient experienced ASTHENIA (Weak) and VOMITING (Vomiting for 12 hours). At the time of the report, ASTHENIA (Weak) outcome was unknown and VOMITING (Vomiting for 12 hours) had resolved. Not Provided      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.  Treatment information was not provided.    This case was linked to MOD-2021-072681 (Patient Link).