chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Vaccination site reaction
Clinical narrative: flu like symptoms; Injection site reaction; fever of 99; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE REACTION (Injection site reaction) and PYREXIA (fever of 99) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE REACTION (Injection site reaction) and PYREXIA (fever of 99). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 28-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE REACTION (Injection site reaction) and PYREXIA (fever of 99) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, Pain, Rash
Clinical narrative: Had aches and pains; Today, I have a rash all over my neck and lymph nodes under jaw are slightly swollen on both sides; Today, I have a rash all over my neck and lymph nodes under jaw are slightly swollen on both sides; 30 minutes ago, went to take a shower, got out, I have a big bruise, under skin on my left arm, down 2-3 inches below from where I got injection - size of palm of my hand. 3 1/2 inches long and 1/2 an inch wide.; This spontaneous case was reported by a nurse and describes the occurrence of CONTUSION (30 minutes ago, went to take a shower, got out, I have a big bruise, under skin on my left arm, down 2-3 inches below from where I got injection - size of palm of my hand. 3 1/2 inches long and 1/2 an inch wide.), PAIN (Had aches and pains), RASH (Today, I have a rash all over my neck and lymph nodes under jaw are slightly swollen on both sides) and LYMPHADENOPATHY (Today, I have a rash all over my neck and lymph nodes under jaw are slightly swollen on both sides) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 013A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ROSUVASTATIN CALCIUM (CRESTOR), ATORVASTATIN CALCIUM (LIPITOR) and LEVOTHYROXINE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021 at 8:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced CONTUSION (30 minutes ago, went to take a shower, got out, I have a big bruise, under skin on my left arm, down 2-3 inches below from where I got injection - size of palm of my hand. 3 1/2 inches long and 1/2 an inch wide.), RASH (Today, I have a rash all over my neck and lymph nodes under jaw are slightly swollen on both sides) and LYMPHADENOPATHY (Today, I have a rash all over my neck and lymph nodes under jaw are slightly swollen on both sides). On an unknown date, the patient experienced PAIN (Had aches and pains). At the time of the report, CONTUSION (30 minutes ago, went to take a shower, got out, I have a big bruise, under skin on my left arm, down 2-3 inches below from where I got injection - size of palm of my hand. 3 1/2 inches long and 1/2 an inch wide.), PAIN (Had aches and pains), RASH (Today, I have a rash all over my neck and lymph nodes under jaw are slightly swollen on both sides) and LYMPHADENOPATHY (Today, I have a rash all over my neck and lymph nodes under jaw are slightly swollen on both sides) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   As reported patient used pure aloe lotion on the area and felt better.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vaccination site mass, Vaccination site warmth
Clinical narrative: Slight bump underneath injection site; arm warm to touch at site of injection; chills; sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Slight bump underneath injection site), VACCINATION SITE WARMTH (arm warm to touch at site of injection), CHILLS (chills), MYALGIA (sore arm) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, CLONIDINE and LABETALOL for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE MASS (Slight bump underneath injection site), VACCINATION SITE WARMTH (arm warm to touch at site of injection), CHILLS (chills), MYALGIA (sore arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 09-Mar-2021, CHILLS (chills), MYALGIA (sore arm) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE MASS (Slight bump underneath injection site) had not resolved and VACCINATION SITE WARMTH (arm warm to touch at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       As reported patient experienced chills, arm was sore, and headache. Took Tylenol 8Mar2021overnight after getting first dose. Also experienced slight bump underneath injection site..
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Muscle soreness; Arm is killing him; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness) and VACCINATION SITE PAIN (Arm is killing him) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-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 MYALGIA (Muscle soreness) and VACCINATION SITE PAIN (Arm is killing him). At the time of the report, MYALGIA (Muscle soreness) and VACCINATION SITE PAIN (Arm is killing him) 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. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever 104F; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 104F), PAIN (body aches) and HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-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 PYREXIA (Fever 104F), PAIN (body aches) and HEADACHE (headaches). At the time of the report, PYREXIA (Fever 104F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: tenderness; swelling; chills; pain in left arm; fever; fatigue; headache; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), SWELLING (swelling), CHILLS (chills), VACCINATION SITE PAIN (pain in left arm) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced TENDERNESS (tenderness), SWELLING (swelling), CHILLS (chills), VACCINATION SITE PAIN (pain in left arm), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, TENDERNESS (tenderness), SWELLING (swelling), CHILLS (chills), VACCINATION SITE PAIN (pain in left arm), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Tenderness, Vaccination site pain
Clinical narrative: tenderness; swelling; chills; pain in left arm; fever; fatigue; headache; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), SWELLING (swelling), CHILLS (chills), VACCINATION SITE PAIN (pain in left arm) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced TENDERNESS (tenderness), SWELLING (swelling), CHILLS (chills), VACCINATION SITE PAIN (pain in left arm), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, TENDERNESS (tenderness), SWELLING (swelling), CHILLS (chills), VACCINATION SITE PAIN (pain in left arm), PYREXIA (fever), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Injection site pain, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (feels pretty bad), headache, myalgia (muscle pain), fatigue and nausea in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 037A21B) for an unknown indication. The occurrence of additional events detailed below. No medical history provided. On Apr 1, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced feeling abnormal (feels pretty bad), headache, myalgia (muscle pain), fatigue, nausea, pyrexia (low-grade temperature) and injection site pain (left arm is sore). At the time of the report, feeling abnormal (feels pretty bad), headache, myalgia (muscle pain), fatigue, nausea, pyrexia (low-grade temperature) and injection site pain (left arm is sore) outcome: unknown. The patient was on blood thinner.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (feels pretty bad), headache, myalgia (muscle pain), fatigue and nausea in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 037A21B) for an unknown indication. The occurrence of additional events detailed below. No medical history provided. On Apr 1, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced feeling abnormal (feels pretty bad), headache, myalgia (muscle pain), fatigue, nausea, pyrexia (low-grade temperature) and injection site pain (left arm is sore). At the time of the report, feeling abnormal (feels pretty bad), headache, myalgia (muscle pain), fatigue, nausea, pyrexia (low-grade temperature) and injection site pain (left arm is sore) outcome: unknown. The patient was on blood thinner.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure increased, Dyspnoea, Feeling abnormal, Feeling hot
Clinical narrative: blood pressure around 198/95; heart beat is on 95bpm; Sweating; Felt horrible; throat started to closed; difficulty of breathing; heart beat was on 100-120 bpm; blood press was high over 130-150.; warm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), FEELING ABNORMAL (Felt horrible), FEELING HOT (warm), THROAT TIGHTNESS (throat started to closed) and DYSPNOEA (difficulty of breathing) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included xendrofine iGg, GABBA penting, miopity, AMITRIPTYLINE, Simbo cords, ProAir                                                         emergency lungs, TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER), MONTELUKAST SODIUM (SINGULAIR) and pills to sleep sometimes for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Feb-2021, the patient experienced FEELING HOT (warm).   On 24-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), FEELING ABNORMAL (Felt horrible), THROAT TIGHTNESS (throat started to closed), DYSPNOEA (difficulty of breathing), HEART RATE INCREASED (heart beat was on 100-120 bpm) and BLOOD PRESSURE INCREASED (blood press was high over 130-150.).   On 02-Apr-2021, the patient experienced BLOOD PRESSURE ABNORMAL (blood pressure around 198/95) and HEART RATE INCREASED (heart beat is on 95bpm). At the time of the report, HYPERHIDROSIS (Sweating), FEELING ABNORMAL (Felt horrible), FEELING HOT (warm), THROAT TIGHTNESS (throat started to closed), DYSPNOEA (difficulty of breathing), HEART RATE INCREASED (heart beat was on 100-120 bpm), BLOOD PRESSURE INCREASED (blood press was high over 130-150.), BLOOD PRESSURE ABNORMAL (blood pressure around 198/95) and HEART RATE INCREASED (heart beat is on 95bpm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant products included xendrofine iGg, GABBA penting, miopity, AMITRIPTYLINE, Simbo cords, ProAir                                                         emergency lungs, TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER), MONTELUKAST SODIUM (SINGULAIR) and pills to sleep sometimes for an unknown indication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: NNI
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Throat tightness
Clinical narrative: blood pressure around 198/95; heart beat is on 95bpm; Sweating; Felt horrible; throat started to closed; difficulty of breathing; heart beat was on 100-120 bpm; blood press was high over 130-150.; warm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), FEELING ABNORMAL (Felt horrible), FEELING HOT (warm), THROAT TIGHTNESS (throat started to closed) and DYSPNOEA (difficulty of breathing) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included xendrofine iGg, GABBA penting, miopity, AMITRIPTYLINE, Simbo cords, ProAir                                                         emergency lungs, TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER), MONTELUKAST SODIUM (SINGULAIR) and pills to sleep sometimes for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Feb-2021, the patient experienced FEELING HOT (warm).   On 24-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), FEELING ABNORMAL (Felt horrible), THROAT TIGHTNESS (throat started to closed), DYSPNOEA (difficulty of breathing), HEART RATE INCREASED (heart beat was on 100-120 bpm) and BLOOD PRESSURE INCREASED (blood press was high over 130-150.).   On 02-Apr-2021, the patient experienced BLOOD PRESSURE ABNORMAL (blood pressure around 198/95) and HEART RATE INCREASED (heart beat is on 95bpm). At the time of the report, HYPERHIDROSIS (Sweating), FEELING ABNORMAL (Felt horrible), FEELING HOT (warm), THROAT TIGHTNESS (throat started to closed), DYSPNOEA (difficulty of breathing), HEART RATE INCREASED (heart beat was on 100-120 bpm), BLOOD PRESSURE INCREASED (blood press was high over 130-150.), BLOOD PRESSURE ABNORMAL (blood pressure around 198/95) and HEART RATE INCREASED (heart beat is on 95bpm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant products included xendrofine iGg, GABBA penting, miopity, AMITRIPTYLINE, Simbo cords, ProAir                                                         emergency lungs, TIOTROPIUM BROMIDE (SPIRIVA HANDIHALER), MONTELUKAST SODIUM (SINGULAIR) and pills to sleep sometimes for an unknown indication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: NNI
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Little bit fever/ Fever 100.4 degree temperature; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (Little bit fever/ Fever 100.4 degree temperature) and CHILLS (Shivers) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Chronic obstructive pulmonary disease.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced CHILLS (Shivers). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (Little bit fever/ Fever 100.4 degree temperature). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (Little bit fever/ Fever 100.4 degree temperature) and CHILLS (Shivers) 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.    This case was linked to MOD-2021-066333 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching on stomach; Rash on stomach and back of neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on stomach) and RASH (Rash on stomach and back of neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PRURITUS (Itching on stomach) and RASH (Rash on stomach and back of neck). At the time of the report, PRURITUS (Itching on stomach) and RASH (Rash on stomach and back of neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. No treatment information after the first dose was provided. Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-066174, MOD-2021-066174 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus
Clinical narrative: itchy; swelling of lips; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and LIP SWELLING (swelling of lips) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 PRURITUS (itchy) and LIP SWELLING (swelling of lips). At the time of the report, PRURITUS (itchy) and LIP SWELLING (swelling of lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. Treatment for the pruritus includes cream.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin discomfort, Urticaria
Clinical narrative: Hives/Urticaria generalised; She wanted to rip her skin off; Itching at the back of the neck; Rash at the back of the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives/Urticaria generalised), SKIN DISCOMFORT (She wanted to rip her skin off), PRURITUS (Itching at the back of the neck) and RASH (Rash at the back of the neck) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives/Urticaria generalised), SKIN DISCOMFORT (She wanted to rip her skin off), PRURITUS (Itching at the back of the neck) and RASH (Rash at the back of the neck). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. In April 2021, URTICARIA (Hives/Urticaria generalised), SKIN DISCOMFORT (She wanted to rip her skin off), PRURITUS (Itching at the back of the neck) and RASH (Rash at the back of the neck) had resolved.            concomitant medications include Flavonoid Plus 2 times a day   Treatment information include Steroids, Antihistamine, Topical Cream.   This case was linked to MOD-2021-066172 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow up received, patient race and ethnic group ,patient weight and height details updated, events outcome details information updated, concomitant medications updated
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in a 50-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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication information was provided. No treatment product information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she said she was very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she said she was very sick) 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 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (she said she was very sick). At the time of the report, ILLNESS (she said she was very sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus
Clinical narrative: itching; red bump on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and LIMB DISCOMFORT (red bump on the left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 31-Mar-2021, the patient experienced PRURITUS (itching) and LIMB DISCOMFORT (red bump on the left arm). At the time of the report, PRURITUS (itching) and LIMB DISCOMFORT (red bump on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itchiness; Redness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and ERYTHEMA (Redness in her arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRURITUS (Itchiness) and ERYTHEMA (Redness in her arm). At the time of the report, PRURITUS (Itchiness) and ERYTHEMA (Redness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Somnolence, Vaccination site induration
Clinical narrative: She was very light headed; She slept for 24 hours; Her arm was hard around injection site; She was very tired; She was nauseated; Her arm was swollen around injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She was very light headed), SOMNOLENCE (She slept for 24 hours), VACCINATION SITE INDURATION (Her arm was hard around injection site), FATIGUE (She was very tired) and NAUSEA (She was nauseated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 19-Nov-2020. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and LEVOTHYROXINE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (She was very light headed), SOMNOLENCE (She slept for 24 hours), VACCINATION SITE INDURATION (Her arm was hard around injection site), FATIGUE (She was very tired), NAUSEA (She was nauseated) and VACCINATION SITE SWELLING (Her arm was swollen around injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MECLOZINE HYDROCHLORIDE (BONINE) at an unspecified dose and frequency. At the time of the report, DIZZINESS (She was very light headed), SOMNOLENCE (She slept for 24 hours), VACCINATION SITE INDURATION (Her arm was hard around injection site), FATIGUE (She was very tired), NAUSEA (She was nauseated) and VACCINATION SITE SWELLING (Her arm was swollen around injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: She was very light headed; She slept for 24 hours; Her arm was hard around injection site; She was very tired; She was nauseated; Her arm was swollen around injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She was very light headed), SOMNOLENCE (She slept for 24 hours), VACCINATION SITE INDURATION (Her arm was hard around injection site), FATIGUE (She was very tired) and NAUSEA (She was nauseated) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 19-Nov-2020. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and LEVOTHYROXINE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (She was very light headed), SOMNOLENCE (She slept for 24 hours), VACCINATION SITE INDURATION (Her arm was hard around injection site), FATIGUE (She was very tired), NAUSEA (She was nauseated) and VACCINATION SITE SWELLING (Her arm was swollen around injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MECLOZINE HYDROCHLORIDE (BONINE) at an unspecified dose and frequency. At the time of the report, DIZZINESS (She was very light headed), SOMNOLENCE (She slept for 24 hours), VACCINATION SITE INDURATION (Her arm was hard around injection site), FATIGUE (She was very tired), NAUSEA (She was nauseated) and VACCINATION SITE SWELLING (Her arm was swollen around injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Vaccination site induration, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Site of injection is lumpy; Site of injection is itchy; site of injection is hard; Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Site of injection is lumpy), VACCINATION SITE PRURITUS (Site of injection is itchy), VACCINATION SITE INDURATION (site of injection is hard) and SNEEZING (Sneezing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE MASS (Site of injection is lumpy), VACCINATION SITE PRURITUS (Site of injection is itchy), VACCINATION SITE INDURATION (site of injection is hard) and SNEEZING (Sneezing). At the time of the report, VACCINATION SITE MASS (Site of injection is lumpy), VACCINATION SITE PRURITUS (Site of injection is itchy), VACCINATION SITE INDURATION (site of injection is hard) and SNEEZING (Sneezing) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced TINNITUS (Tinnitus). The patient was treated with PREDNISONE at a dose of 1 dosage form and CYANOCOBALAMIN (B12 1000 SR) at a dose of 1 dosage form. On 20-Mar-2021, TINNITUS (Tinnitus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. Treatment medications also included Fluid pill.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Product dose omission issue
Clinical narrative: Bad back; Cannot go gor second dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Bad back) and PRODUCT DOSE OMISSION ISSUE (Cannot go gor second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Bad back) and PRODUCT DOSE OMISSION ISSUE (Cannot go gor second dose). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Bad back) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Cannot go gor second dose) had resolved.        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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication was not provided.   This case was linked to MOD-2021-066184, MOD-2021-066184 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Eye oedema, Fatigue, Hypoaesthesia, Hypotonia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confusion that lasted about 2 hours), VISION BLURRED (visions problems; started off blurry then it got to be tunnel vision and could only see a little bit in front of her), HYPOAESTHESIA (numbness and tingling in the fingers, toes, and face), PARAESTHESIA (tingling in the fingers, toes, and face) and HYPOTONIA (face felt droopy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Soy allergy and Food allergy (American cheese). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced CONFUSIONAL STATE (confusion that lasted about 2 hours), VISION BLURRED (visions problems; started off blurry then it got to be tunnel vision and could only see a little bit in front of her), HYPOAESTHESIA (numbness and tingling in the fingers, toes, and face), PARAESTHESIA (tingling in the fingers, toes, and face), HYPOTONIA (face felt droopy), EYE OEDEMA (eyeballs felt sort of swollen) and FATIGUE (dizzy fatigue where it felt like someone had drugged her). At the time of the report, CONFUSIONAL STATE (confusion that lasted about 2 hours), VISION BLURRED (visions problems; started off blurry then it got to be tunnel vision and could only see a little bit in front of her), HYPOAESTHESIA (numbness and tingling in the fingers, toes, and face), PARAESTHESIA (tingling in the fingers, toes, and face), HYPOTONIA (face felt droopy), EYE OEDEMA (eyeballs felt sort of swollen) and FATIGUE (dizzy fatigue where it felt like someone had drugged her) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and Treatment medications were not provided by reporter. Reporter did not allow further contact.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confusion that lasted about 2 hours), VISION BLURRED (visions problems; started off blurry then it got to be tunnel vision and could only see a little bit in front of her), HYPOAESTHESIA (numbness and tingling in the fingers, toes, and face), PARAESTHESIA (tingling in the fingers, toes, and face) and HYPOTONIA (face felt droopy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Soy allergy and Food allergy (American cheese). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced CONFUSIONAL STATE (confusion that lasted about 2 hours), VISION BLURRED (visions problems; started off blurry then it got to be tunnel vision and could only see a little bit in front of her), HYPOAESTHESIA (numbness and tingling in the fingers, toes, and face), PARAESTHESIA (tingling in the fingers, toes, and face), HYPOTONIA (face felt droopy), EYE OEDEMA (eyeballs felt sort of swollen) and FATIGUE (dizzy fatigue where it felt like someone had drugged her). At the time of the report, CONFUSIONAL STATE (confusion that lasted about 2 hours), VISION BLURRED (visions problems; started off blurry then it got to be tunnel vision and could only see a little bit in front of her), HYPOAESTHESIA (numbness and tingling in the fingers, toes, and face), PARAESTHESIA (tingling in the fingers, toes, and face), HYPOTONIA (face felt droopy), EYE OEDEMA (eyeballs felt sort of swollen) and FATIGUE (dizzy fatigue where it felt like someone had drugged her) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and Treatment medications were not provided by reporter. Reporter did not allow further contact.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: feverish; shaking so bad he couldn't stop; had pain from the bottom of elbow to the bottom of the neck; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish), TREMOR (shaking so bad he couldn't stop) and PAIN IN EXTREMITY (had pain from the bottom of elbow to the bottom of the neck) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (feverish), TREMOR (shaking so bad he couldn't stop) and PAIN IN EXTREMITY (had pain from the bottom of elbow to the bottom of the neck). On 02-Apr-2021, PYREXIA (feverish), TREMOR (shaking so bad he couldn't stop) and PAIN IN EXTREMITY (had pain from the bottom of elbow to the bottom of the neck) had resolved.        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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up re received on 16-JUN-2021 and it contains No new information.
Age: 43.0
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 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-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 an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Concomitant and Treatment medications were not provided by reporter.   This case was linked to MOD-2021-066191 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Head discomfort, Headache, Hyperhidrosis
Clinical narrative: Swollen lymph node; couldn't lift head off pillow; head and neck were in a lot of pain; sweating; radiating dull aches in chest; tender to touch right over collar bone; Lymph node pain; shivering; head and neck were in a lot of pain/ headache; fever over 103; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (couldn't lift head off pillow), NECK PAIN (head and neck were in a lot of pain), HYPERHIDROSIS (sweating), CHEST PAIN (radiating dull aches in chest) and TENDERNESS (tender to touch right over collar bone) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (couldn't lift head off pillow), NECK PAIN (head and neck were in a lot of pain), HYPERHIDROSIS (sweating), CHEST PAIN (radiating dull aches in chest), TENDERNESS (tender to touch right over collar bone), LYMPH NODE PAIN (Lymph node pain), CHILLS (shivering), HEADACHE (head and neck were in a lot of pain/ headache), PYREXIA (fever over 103) and LYMPHADENOPATHY (Swollen lymph node). At the time of the report, HEAD DISCOMFORT (couldn't lift head off pillow), NECK PAIN (head and neck were in a lot of pain), HYPERHIDROSIS (sweating), CHEST PAIN (radiating dull aches in chest), TENDERNESS (tender to touch right over collar bone), LYMPH NODE PAIN (Lymph node pain), CHILLS (shivering), HEADACHE (head and neck were in a lot of pain/ headache), PYREXIA (fever over 103) and LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.            Concomitant and Treatment medications were not provided by reporter.   This case was linked to MOD-2021-066190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: TCR  received on 28-JUN-2021 - New event Swollen lymph node updated
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Neck pain, Pyrexia, Tenderness
Clinical narrative: Swollen lymph node; couldn't lift head off pillow; head and neck were in a lot of pain; sweating; radiating dull aches in chest; tender to touch right over collar bone; Lymph node pain; shivering; head and neck were in a lot of pain/ headache; fever over 103; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (couldn't lift head off pillow), NECK PAIN (head and neck were in a lot of pain), HYPERHIDROSIS (sweating), CHEST PAIN (radiating dull aches in chest) and TENDERNESS (tender to touch right over collar bone) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (couldn't lift head off pillow), NECK PAIN (head and neck were in a lot of pain), HYPERHIDROSIS (sweating), CHEST PAIN (radiating dull aches in chest), TENDERNESS (tender to touch right over collar bone), LYMPH NODE PAIN (Lymph node pain), CHILLS (shivering), HEADACHE (head and neck were in a lot of pain/ headache), PYREXIA (fever over 103) and LYMPHADENOPATHY (Swollen lymph node). At the time of the report, HEAD DISCOMFORT (couldn't lift head off pillow), NECK PAIN (head and neck were in a lot of pain), HYPERHIDROSIS (sweating), CHEST PAIN (radiating dull aches in chest), TENDERNESS (tender to touch right over collar bone), LYMPH NODE PAIN (Lymph node pain), CHILLS (shivering), HEADACHE (head and neck were in a lot of pain/ headache), PYREXIA (fever over 103) and LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.            Concomitant and Treatment medications were not provided by reporter.   This case was linked to MOD-2021-066190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: TCR  received on 28-JUN-2021 - New event Swollen lymph node updated