chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: sore arm; tiredness; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (sore arm) and FATIGUE (tiredness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, OLMESARTAN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced MYALGIA (sore arm) and FATIGUE (tiredness). On 04-Apr-2021, FATIGUE (tiredness) had resolved. On 05-Apr-2021, MYALGIA (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided Concomitant medications include: Diuretics 25mg and other BP medications   This case was linked to MOD-2021-163836 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: there are bumps at the injection site; Vaccination site erythema; itching at the injection site; area around injection site is slightly swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (there are bumps at the injection site), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (area around injection site is slightly swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and POLYCARBOPHIL CALCIUM (FIBER) for an unknown indication.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (there are bumps at the injection site), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (area around injection site is slightly swollen). The patient was treated with CORTISONE for Itching, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MASS (there are bumps at the injection site), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (area around injection site is slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Hypoaesthesia, Pain in extremity, Peripheral coldness
Clinical narrative: hands and feet cold with a sensation of numbness all day; hands and feet cold with a sensation of numbness all day; bruising on the legs/bruises changed its color from violet to brown; pain on the legs; headaches; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising on the legs/bruises changed its color from violet to brown), PAIN IN EXTREMITY (pain on the legs), PERIPHERAL COLDNESS (hands and feet cold with a sensation of numbness all day), HYPOAESTHESIA (hands and feet cold with a sensation of numbness all day) and HEADACHE (headaches) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-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 22-May-2021, the patient experienced HEADACHE (headaches). On 23-May-2021, the patient experienced CONTUSION (bruising on the legs/bruises changed its color from violet to brown) and PAIN IN EXTREMITY (pain on the legs). On 24-May-2021, the patient experienced PERIPHERAL COLDNESS (hands and feet cold with a sensation of numbness all day) and HYPOAESTHESIA (hands and feet cold with a sensation of numbness all day). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CONTUSION (bruising on the legs/bruises changed its color from violet to brown), PAIN IN EXTREMITY (pain on the legs), PERIPHERAL COLDNESS (hands and feet cold with a sensation of numbness all day), HYPOAESTHESIA (hands and feet cold with a sensation of numbness all day) and HEADACHE (headaches) had not resolved.             No concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on left cheek area, neck ,face, upper chest; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on left cheek area, neck ,face, upper chest) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives on left cheek area, neck ,face, upper chest). On 27-Apr-2021, URTICARIA (hives on left cheek area, neck ,face, upper chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: high fever; 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 PYREXIA (high fever) 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 22-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 an unknown date, the patient experienced PYREXIA (high fever). At the time of the report, PYREXIA (high fever) had not resolved.            No concomitant medication reported. No treatment information reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: bloody nose everyday until yesterday; This spontaneous case was reported by a nurse and describes the occurrence of EPISTAXIS (bloody nose everyday until yesterday) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced EPISTAXIS (bloody nose everyday until yesterday). On 23-May-2021, EPISTAXIS (bloody nose everyday until yesterday) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Iron deficiency anaemia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IRON DEFICIENCY ANAEMIA (iron deficiency anemia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.  No Medical History information was reported. On 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 IRON DEFICIENCY ANAEMIA (iron deficiency anemia). At the time of the report, IRON DEFICIENCY ANAEMIA (iron deficiency anemia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication history not provided. Treatment information was unknown. Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Right knee pain; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Right knee pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (He had a right knee replacement 8 years ago) in 2013.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ARTHRALGIA (Right knee pain). At the time of the report, ARTHRALGIA (Right knee pain) outcome was unknown.            No concomitant medications were reported Treatment information was not provided
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: 2 bloody noses; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (2 bloody noses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (2 bloody noses). At the time of the report, EPISTAXIS (2 bloody noses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: loose stools; stomach troubles; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (loose stools) and ABDOMINAL DISCOMFORT (stomach troubles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (loose stools) and ABDOMINAL DISCOMFORT (stomach troubles). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 1 dosage form. At the time of the report, DIARRHOEA (loose stools) and ABDOMINAL DISCOMFORT (stomach troubles) outcome was unknown.            No concomitant medications were reported
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Tiny bit sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Tiny bit sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 032B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL and OLMESARTAN for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Tiny bit sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency. On 01-May-2021, MYALGIA (Tiny bit sore arm) had resolved.            Concomitant medication included Diuretic 25mg and also an unknown BP med. Patient stated that she takes 3 BP medications.   This case was linked to MOD-2021-163836 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Miliaria, Pruritus, Skin irritation, Swelling
Clinical narrative: Heat radiating from rash; Itching on neck; Soft swollen lump in armpit; Warmness and irritation that they scratched while sleeping; Warmness and irritation that they scratched while sleeping; This spontaneous case was reported by a consumer and describes the occurrence of MILIARIA (Heat radiating from rash), PRURITUS (Itching on neck), SWELLING (Soft swollen lump in armpit), FEELING HOT (Warmness and irritation that they scratched while sleeping) and SKIN IRRITATION (Warmness and irritation that they scratched while sleeping) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21B) for COVID-19 vaccination.     no medical history reported by reporter.  Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN B3 and LINUM USITATISSIMUM SEED OIL (FLAXSEED OIL NATURE MADE) for an unknown indication.    On 14-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 MILIARIA (Heat radiating from rash), PRURITUS (Itching on neck), SWELLING (Soft swollen lump in armpit), FEELING HOT (Warmness and irritation that they scratched while sleeping) and SKIN IRRITATION (Warmness and irritation that they scratched while sleeping). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MILIARIA (Heat radiating from rash), PRURITUS (Itching on neck), SWELLING (Soft swollen lump in armpit), FEELING HOT (Warmness and irritation that they scratched while sleeping) and SKIN IRRITATION (Warmness and irritation that they scratched while sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site arms; 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 PAIN (sore injection site arms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 SITE PAIN (sore injection site arms). At the time of the report, VACCINATION SITE PAIN (sore injection site arms) 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
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Illness, Myalgia
Clinical narrative: vaccination site cyst; Slept long time; Was feeling cold; Felt very sick; Felt tired; Had chills; Had fever; Soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CYST (vaccination site cyst), SOMNOLENCE (Slept long time), FEELING COLD (Was feeling cold), ILLNESS (Felt very sick) and FATIGUE (Felt tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced VACCINATION SITE CYST (vaccination site cyst), SOMNOLENCE (Slept long time), FEELING COLD (Was feeling cold), ILLNESS (Felt very sick), FATIGUE (Felt tired), CHILLS (Had chills), PYREXIA (Had fever) and MYALGIA (Soreness on arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-May-2021, SOMNOLENCE (Slept long time), FEELING COLD (Was feeling cold), ILLNESS (Felt very sick), FATIGUE (Felt tired), CHILLS (Had chills) and PYREXIA (Had fever) had resolved. At the time of the report, VACCINATION SITE CYST (vaccination site cyst) outcome was unknown and MYALGIA (Soreness on arm) had resolved.            Concomitant medication was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Vaccination site cyst
Clinical narrative: vaccination site cyst; Slept long time; Was feeling cold; Felt very sick; Felt tired; Had chills; Had fever; Soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CYST (vaccination site cyst), SOMNOLENCE (Slept long time), FEELING COLD (Was feeling cold), ILLNESS (Felt very sick) and FATIGUE (Felt tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced VACCINATION SITE CYST (vaccination site cyst), SOMNOLENCE (Slept long time), FEELING COLD (Was feeling cold), ILLNESS (Felt very sick), FATIGUE (Felt tired), CHILLS (Had chills), PYREXIA (Had fever) and MYALGIA (Soreness on arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-May-2021, SOMNOLENCE (Slept long time), FEELING COLD (Was feeling cold), ILLNESS (Felt very sick), FATIGUE (Felt tired), CHILLS (Had chills) and PYREXIA (Had fever) had resolved. At the time of the report, VACCINATION SITE CYST (vaccination site cyst) outcome was unknown and MYALGIA (Soreness on arm) had resolved.            Concomitant medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in hand; numbness in finger; 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 HYPOAESTHESIA (numbness in hand) and HYPOAESTHESIA (numbness in finger) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Numbness (numbness in hand numbness in finger).    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 HYPOAESTHESIA (numbness in hand) and HYPOAESTHESIA (numbness in finger). At the time of the report, HYPOAESTHESIA (numbness in hand) and HYPOAESTHESIA (numbness in finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment information was provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: I as driving to work, and ended up in the middle of city, don't know how I got there. It was like a severe brain fog; I'm still feeling tired and run down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (I as driving to work, and ended up in the middle of city, don't know how I got there. It was like a severe brain fog) and FATIGUE (I'm still feeling tired and run down) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced FEELING ABNORMAL (I as driving to work, and ended up in the middle of city, don't know how I got there. It was like a severe brain fog) and FATIGUE (I'm still feeling tired and run down). On 20-May-2021, FEELING ABNORMAL (I as driving to work, and ended up in the middle of city, don't know how I got there. It was like a severe brain fog) had resolved. At the time of the report, FATIGUE (I'm still feeling tired and run down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: Product physical issue, Wheezing
Clinical narrative: Started wheezing the day after; Second vaccine milky color; 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 WHEEZING (Started wheezing the day after) and PRODUCT PHYSICAL ISSUE (Second vaccine milky color) 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, the patient experienced WHEEZING (Started wheezing the day after) and PRODUCT PHYSICAL ISSUE (Second vaccine milky color). At the time of the report, WHEEZING (Started wheezing the day after) outcome was unknown and PRODUCT PHYSICAL ISSUE (Second vaccine milky color) had resolved.            No concomitant  medications were reported. No treatment  information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Breast cyst, Breast pain
Clinical narrative: Pain in her breast; cyst in her breast; This spontaneous case was reported by a pharmacist and describes the occurrence of BREAST PAIN (Pain in her breast) and BREAST CYST (cyst in her breast) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Pain in her breast) and BREAST CYST (cyst in her breast). On 15-Apr-2021, BREAST PAIN (Pain in her breast) and BREAST CYST (cyst in her breast) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea since I took my first vaccine what should I do it has been 7 days; 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 DIARRHOEA (severe diarrhea since I took my first vaccine what should I do it has been 7 days) 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 DIARRHOEA (severe diarrhea since I took my first vaccine what should I do it has been 7 days). At the time of the report, DIARRHOEA (severe diarrhea since I took my first vaccine what should I do it has been 7 days) 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: Headache, Pain, Somnolence
Clinical narrative: been asleep for the bulk of the day; pain; headache; 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 SOMNOLENCE (been asleep for the bulk of the day), PAIN (pain) and HEADACHE (headache) 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 SOMNOLENCE (been asleep for the bulk of the day), PAIN (pain) and HEADACHE (headache). At the time of the report, SOMNOLENCE (been asleep for the bulk of the day) outcome was unknown and PAIN (pain) and HEADACHE (headache) had not resolved.            No concomitant medications were reported  No treatment drugs were reported  Consent to follow up unknown
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I want to report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I want to report a side effect) 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 24-May-2021, the patient experienced VACCINATION COMPLICATION (I want to report a side effect). At the time of the report, VACCINATION COMPLICATION (I want to report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: have a round sore spot that is huge around were I got my shot; sore spot that is huge around were I got my shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (have a round sore spot that is huge around were I got my shot) and VACCINATION SITE PAIN (sore spot that is huge around were I got my shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 (have a round sore spot that is huge around were I got my shot) and VACCINATION SITE PAIN (sore spot that is huge around were I got my shot). At the time of the report, VACCINATION SITE REACTION (have a round sore spot that is huge around were I got my shot) and VACCINATION SITE PAIN (sore spot that is huge around were I got my shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided.  patients lab tests data not provided. Concomitant product use was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough after 1st dose) 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 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cough after 1st dose). At the time of the report, COUGH (cough after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Lethargy, Mouth swelling, Vision blurred
Clinical narrative: Metallic taste; Blurry vision; Swollen mouth; Lethargic; Feel like crap; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Metallic taste), VISION BLURRED (Blurry vision), MOUTH SWELLING (Swollen mouth), LETHARGY (Lethargic) and FEELING ABNORMAL (Feel like crap) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     Concomitant products included INSULIN for Diabetes, SEMAGLUTIDE (OZEMPIC) for an unknown indication.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced DYSGEUSIA (Metallic taste), VISION BLURRED (Blurry vision), MOUTH SWELLING (Swollen mouth), LETHARGY (Lethargic) and FEELING ABNORMAL (Feel like crap). At the time of the report, DYSGEUSIA (Metallic taste), VISION BLURRED (Blurry vision), MOUTH SWELLING (Swollen mouth), LETHARGY (Lethargic) and FEELING ABNORMAL (Feel like crap) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; 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 NASOPHARYNGITIS (Cold) 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 NASOPHARYNGITIS (Cold). At the time of the report, NASOPHARYNGITIS (Cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: Feel really bad; Had a headache; 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 FEELING ABNORMAL (Feel really bad) and HEADACHE (Had a headache) 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 FEELING ABNORMAL (Feel really bad) and HEADACHE (Had a headache). At the time of the report, FEELING ABNORMAL (Feel really bad) and HEADACHE (Had a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever up to 104 degrees; 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 PYREXIA (Fever up to 104 degrees) 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 23-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced PYREXIA (Fever up to 104 degrees). At the time of the report, PYREXIA (Fever up to 104 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, Body temperature: 104 (High) fever up to 104 degrees. On an unknown date, Body temperature: 103.8 (High) Fever 103.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Backache; Chills; Fever; Headache; Overall fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Backache), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Overall fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 BACK PAIN (Backache), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Overall fatigue). At the time of the report, BACK PAIN (Backache), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Overall fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: His legs but mostly his left leg, have been swollen/ Legs were going to puff; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (His legs but mostly his left leg, have been swollen/ Legs were going to puff) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (His legs but mostly his left leg, have been swollen/ Legs were going to puff). At the time of the report, PERIPHERAL SWELLING (His legs but mostly his left leg, have been swollen/ Legs were going to puff) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Since then I have noticed blood spots on both my right and left forearms.; This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (Since then I have noticed blood spots on both my right and left forearms.) 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 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced RASH MACULAR (Since then I have noticed blood spots on both my right and left forearms.). At the time of the report, RASH MACULAR (Since then I have noticed blood spots on both my right and left forearms.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: not slept since; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (not slept since) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 INSOMNIA (not slept since). At the time of the report, INSOMNIA (not slept since) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: arthritis flare up; 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 ARTHRITIS (arthritis flare up) 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 ARTHRITIS (arthritis flare up). At the time of the report, ARTHRITIS (arthritis flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; 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 PYREXIA (Fever) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications information was reported.   Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Insomnia, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Appetite has not come back to normal  yet; Could not sleep; Fever; Chills; Horrible sever body ache,sore arm; Injection site  tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (Appetite has not come back to normal  yet), INSOMNIA (Could not sleep), PYREXIA (Fever) and CHILLS (Chills) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026R1A and 041B218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter. .    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On 22-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (Appetite has not come back to normal  yet), INSOMNIA (Could not sleep), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Horrible sever body ache,sore arm) and VACCINATION SITE PAIN (Injection site  tenderness). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1 dosage form. On 23-May-2021, PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (Appetite has not come back to normal  yet), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Horrible sever body ache,sore arm) and VACCINATION SITE PAIN (Injection site  tenderness) had resolved and INSOMNIA (Could not sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment include: lotion ( to get relief from injection site  tenderness ) patient had stated that she is not on any concomitant medication. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Sore arm; Appetite has not come back to normal  yet; Could not sleep; Fever; Chills; Horrible sever body ache,sore arm; Injection site  tenderness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (Appetite has not come back to normal  yet), INSOMNIA (Could not sleep), PYREXIA (Fever) and CHILLS (Chills) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026R1A and 041B218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter. .    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On 22-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (Appetite has not come back to normal  yet), INSOMNIA (Could not sleep), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Horrible sever body ache,sore arm) and VACCINATION SITE PAIN (Injection site  tenderness). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1 dosage form. On 23-May-2021, PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (Appetite has not come back to normal  yet), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Horrible sever body ache,sore arm) and VACCINATION SITE PAIN (Injection site  tenderness) had resolved and INSOMNIA (Could not sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment include: lotion ( to get relief from injection site  tenderness ) patient had stated that she is not on any concomitant medication. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash macular, Scar, Skin discolouration
Clinical narrative: itchy on his legs; irritating red bumps on arms, irritating red bumps on hands; flakey skin; blotchy skin; discolored skin; severely scarred; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy on his legs), RASH ERYTHEMATOUS (irritating red bumps on arms, irritating red bumps on hands), SKIN EXFOLIATION (flakey skin), RASH MACULAR (blotchy skin) and SKIN DISCOLORATION (discolored skin) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CHLORTHALIDONE and AMLODIPINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (itchy on his legs), RASH ERYTHEMATOUS (irritating red bumps on arms, irritating red bumps on hands), SKIN EXFOLIATION (flakey skin), RASH MACULAR (blotchy skin), SKIN DISCOLORATION (discolored skin) and SCAR (severely scarred). The patient was treated with CLOBETASOL at a dose of 50 ml and TRIAMCINOLONE at a dose of 454 gram. At the time of the report, PRURITUS (itchy on his legs), RASH ERYTHEMATOUS (irritating red bumps on arms, irritating red bumps on hands), SKIN EXFOLIATION (flakey skin), RASH MACULAR (blotchy skin), SKIN DISCOLORATION (discolored skin) and SCAR (severely scarred) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported 95% of the symptoms were resolved.       Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 contains No significant information On 10-Jul-2021: Follow-up information received on 10-JUL-2021 contains Non-significant follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Skin exfoliation
Clinical narrative: itchy on his legs; irritating red bumps on arms, irritating red bumps on hands; flakey skin; blotchy skin; discolored skin; severely scarred; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy on his legs), RASH ERYTHEMATOUS (irritating red bumps on arms, irritating red bumps on hands), SKIN EXFOLIATION (flakey skin), RASH MACULAR (blotchy skin) and SKIN DISCOLORATION (discolored skin) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CHLORTHALIDONE and AMLODIPINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (itchy on his legs), RASH ERYTHEMATOUS (irritating red bumps on arms, irritating red bumps on hands), SKIN EXFOLIATION (flakey skin), RASH MACULAR (blotchy skin), SKIN DISCOLORATION (discolored skin) and SCAR (severely scarred). The patient was treated with CLOBETASOL at a dose of 50 ml and TRIAMCINOLONE at a dose of 454 gram. At the time of the report, PRURITUS (itchy on his legs), RASH ERYTHEMATOUS (irritating red bumps on arms, irritating red bumps on hands), SKIN EXFOLIATION (flakey skin), RASH MACULAR (blotchy skin), SKIN DISCOLORATION (discolored skin) and SCAR (severely scarred) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported 95% of the symptoms were resolved.       Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 contains No significant information On 10-Jul-2021: Follow-up information received on 10-JUL-2021 contains Non-significant follow up.