chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Cold; She now has a larger red area around the injection site but it is not raised; Headache; She initially had a red spot around the injection site that was raised and then cleared up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (She initially had a red spot around the injection site that was raised and then cleared up), VACCINATION SITE ERYTHEMA (She now has a larger red area around the injection site but it is not raised), HEADACHE (Headache) and NASOPHARYNGITIS (Cold) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE SWELLING (She initially had a red spot around the injection site that was raised and then cleared up). On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (She now has a larger red area around the injection site but it is not raised), HEADACHE (Headache) and NASOPHARYNGITIS (Cold). At the time of the report, VACCINATION SITE SWELLING (She initially had a red spot around the injection site that was raised and then cleared up) had resolved and VACCINATION SITE ERYTHEMA (She now has a larger red area around the injection site but it is not raised), HEADACHE (Headache) and NASOPHARYNGITIS (Cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported Treatment medications were not provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: little ache; little swollen; a rash and a round circle all around the injection site; her arm hurt for the first day or two; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events little ache/pain, little swollen/vaccination site swelling, her arm hurt for the first day or two,/vaccination site pain, a rash and a round circle all around the injection site/vaccination site rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 038K20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) little ache, little swollen.  On 2 Feb 2021, the patient experienced the event(s) her arm hurt for the first day or two, a rash and a round circle all around the injection site.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 3 Feb 2021 the outcome of event(s), her arm hurt for the first day or two was resolved. The outcome of event(s), little ache, little swollen, a rash and a round circle all around the injection site was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pruritus, Rash, Vaccination site pain
Clinical narrative: itching; Rash; sharp pain on the arm; nausea; chills; Rash double its width and length; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), RASH (Rash double its width and length), RASH (Rash), VACCINATION SITE PAIN (sharp pain on the arm) and NAUSEA (nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma. Concomitant products included IRBESARTAN and TAFLUPROST (ZIOPTAN) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-1021, the patient experienced RASH (Rash double its width and length). On 02-Feb-2021, the patient experienced NAUSEA (nausea) and CHILLS (chills). On 08-Feb-2021, the patient experienced RASH (Rash) and VACCINATION SITE PAIN (sharp pain on the arm). On 10-Feb-2021, the patient experienced PRURITUS (itching). The patient was treated with CLOBETASOL (topical) on 11-Feb-2021 for Rash, at a dose of UNK, tid. On 05-Feb-2021, NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, PRURITUS (itching), RASH (Rash double its width and length), RASH (Rash) and VACCINATION SITE PAIN (sharp pain on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to dermatologist and treatment for the events included steroid cream.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: low grade headache /headache in the right temple; A spontaneous report was received from a healthcare professional concerning a 72 years old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events low grade headache, headache in the right temple /headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) low grade headache, headache in the right temple.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), low grade headache, headache in the right temple was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Corneal disorder, Eye pain, Headache, Pain in extremity
Clinical narrative: small spot on her Cornea; sore arm; headache; right eye pain; A spontaneous report was received from a healthcare professional concerning a 87-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events right eye pain, small spot on her cornea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) right eye pain. On 10 Feb 2021, the patient experienced the event(s) small spot on her cornea.  Treatment details included Valtrex (1gm tid).  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), right eye pain, small spot on her cornea was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Rash, Rash pruritic
Clinical narrative: Low grade headache; Rash area was itching; Rash and tiny bumps on her knee, moved to other leg and other body parts; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Rash area was itching), RASH (Rash and tiny bumps on her knee, moved to other leg and other body parts) and HEADACHE (Low grade headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination.     No medical history reported.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced RASH PRURITIC (Rash area was itching) and RASH (Rash and tiny bumps on her knee, moved to other leg and other body parts). On 25-Feb-2021, the patient experienced HEADACHE (Low grade headache). At the time of the report, RASH PRURITIC (Rash area was itching), RASH (Rash and tiny bumps on her knee, moved to other leg and other body parts) and HEADACHE (Low grade headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used was not provided by the reporter. Treatment for the events included oral diphenhydramine and anti-itch cream.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Arm hurts; Body aches; Tiredness/ sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches) and FATIGUE (Tiredness/ sleepiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches) and FATIGUE (Tiredness/ sleepiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm hurts), MYALGIA (Body aches) and FATIGUE (Tiredness/ sleepiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) 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-Jan-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 DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: fever; chills; Left deltoid/arm tenderness; Lymph node swelling/Swollen Lymphnodes in R axilla; pain around the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYALGIA (Left deltoid/arm tenderness), LYMPHADENOPATHY (Lymph node swelling/Swollen Lymphnodes in R axilla) and VACCINATION SITE PAIN (pain around the injection site) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Cholesterol and Diabetes. Concurrent medical conditions included Coronary artery disease on 04-Jan-2004. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) from 01-Jan-2015 to an unknown date for Antiplatelet therapy, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 01-Jan-2004 to an unknown date for Coronary artery disease, METFORMIN from 01-Jan-2010 to an unknown date for Diabetes mellitus, PRAVASTATIN from 01-Jan-2004 to an unknown date and EVOLOCUMAB from 01-Jan-2018 to an unknown date for Hyperlipidemia, METOPROLOL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced MYALGIA (Left deltoid/arm tenderness), LYMPHADENOPATHY (Lymph node swelling/Swollen Lymphnodes in R axilla) and VACCINATION SITE PAIN (pain around the injection site). In January 2021, MYALGIA (Left deltoid/arm tenderness) had resolved. On 10-Apr-2021, LYMPHADENOPATHY (Lymph node swelling/Swollen Lymphnodes in R axilla) had resolved. At the time of the report, VACCINATION SITE PAIN (pain around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Ipatient received a steroid injection in lateral sides of both upper legs due to bilateral greater trochanteric bursitis. given to him by an orthopedic surgeon (this was unrelated to the swollen LN). The lymph nodes disappeared and tenderness went away after that by April 10th, 2021.  he is not sure if the systemic absorption of the local steroid injections helped dissolve the lymph nodes.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Made changes as per follow-up1. updated the current medical condition (CAD)2. updated the concomitant medications, their dates, dosage, indications of use3. updated the outcome of events from unknown to Recovered/Resolved along with the dates provided 4. added to the Inarrative supplement
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster
Clinical narrative: He got shingles; fatigued; A spontaneous report was received from a consumer concerning a 71-year-old ,male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt fatigued, and he got shingles.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 19 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient reported that he felt fatigued.On 22 Jan 2021, he got shingles. He had gotten the shingles shot before.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event, felt fatigued,and he got shingles, were unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Urticaria
Clinical narrative: dime size welts (raised hives); nauseous; itchy arms; A spontaneous report was received from a consumer concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nauseous, itchy arms, dime size welts (raised hives).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events nauseous, itchy arms. On 11 Feb 2021, the patient experienced the event dime size welts (raised hives).  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.  On 10 Feb 2021 the outcome of events, nauseous was resolved. On12 Feb 2021 the outcome of event, dime size welts (raised hives) was resolved. The outcome of event, itchy arms was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Bladder pain, Fatigue, Headache, International normalised ratio
Clinical narrative: Arthritis aggravated; Knees were swollen; Fatigue; Headache; Pain in her bladder; Urine odor foul; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Urine odor foul), ARTHRITIS (Arthritis aggravated), JOINT SWELLING (Knees were swollen) and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 06-Feb-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 BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Urine odor foul), ARTHRITIS (Arthritis aggravated), JOINT SWELLING (Knees were swollen), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Urine odor foul), ARTHRITIS (Arthritis aggravated), JOINT SWELLING (Knees were swollen), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, International normalised ratio (3.8-4.2): (High) High. INR normal range is 2-3..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.   This case was linked to MOD-2021-058249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Follow up received on 25-MAR-2021.Date of birth, patient initials and outcome of events were updated,
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Urine odour abnormal
Clinical narrative: Arthritis aggravated; Knees were swollen; Fatigue; Headache; Pain in her bladder; Urine odor foul; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Urine odor foul), ARTHRITIS (Arthritis aggravated), JOINT SWELLING (Knees were swollen) and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 06-Feb-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 BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Urine odor foul), ARTHRITIS (Arthritis aggravated), JOINT SWELLING (Knees were swollen), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, BLADDER PAIN (Pain in her bladder), URINE ODOUR ABNORMAL (Urine odor foul), ARTHRITIS (Arthritis aggravated), JOINT SWELLING (Knees were swollen), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, International normalised ratio (3.8-4.2): (High) High. INR normal range is 2-3..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.   This case was linked to MOD-2021-058249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Follow up received on 25-MAR-2021.Date of birth, patient initials and outcome of events were updated,
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reporting an adverse reaction to the Moderna vaccine; A spontaneous report was received from a HCP about a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an adverse reaction.   The patient's medical history, concomitant medications were not reported.   No information about vaccine was reported  Action taken with mRNA-1273 in response to the events was not reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Body aches; pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included QUERCETIN from November 2020 to an unknown date for Allergy, ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for Birth control, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from January 2021 to an unknown date for Vitamin D deficiency.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm). On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 02-Feb-2021, PAIN IN EXTREMITY (pain in my arm) had resolved. At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Patient temperature was taken throughout the night and never went over 99.5.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: follow up received on 02-MAY-2021 Contains patient demographic details added, concomitant medications was added,  new events was updated, dosage information was updated.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: rapid heart rate; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rapid heart rate.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced the event rapid heart rate.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, rapid heart rate was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Dyspnoea, Myalgia, Pyrexia
Clinical narrative: difficulty breathing; heart hurts; muscle pain; joint pain; fever; rash develop on her her arm and going to her lower extremities; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (heart hurts), RASH (rash develop on her her arm and going to her lower extremities), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RASH (rash develop on her her arm and going to her lower extremities). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (heart hurts), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (heart hurts), RASH (rash develop on her her arm and going to her lower extremities), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: difficulty breathing; heart hurts; muscle pain; joint pain; fever; rash develop on her her arm and going to her lower extremities; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (heart hurts), RASH (rash develop on her her arm and going to her lower extremities), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RASH (rash develop on her her arm and going to her lower extremities). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (heart hurts), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (heart hurts), RASH (rash develop on her her arm and going to her lower extremities), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Pyrexia
Clinical narrative: shortness of breath; dry cough; 103 F/(temperature) was higher earlier; not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), COUGH (dry cough), PYREXIA (103 F/(temperature) was higher earlier) and FATIGUE (not feeling well) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pulmonary embolism (I had a pulmonary embolism about 10 years ago).   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) and FATIGUE (not feeling well). 03-Mar-2021, the patient experienced COUGH (dry cough) and PYREXIA (103 F/(temperature) was higher earlier). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), COUGH (dry cough), PYREXIA (103 F/(temperature) was higher earlier) and FATIGUE (not feeling well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: 103 (High) I had 103 F.         No Concomitant medications were reported. Treatment details included Tylenol and Excedrin. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: NNI
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Neck pain, Pain
Clinical narrative: Tired; Pain in cheek bone; Pain in Neck; pain on her shoulder around her collar bone; A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tired, pain on her shoulder around her collar bone, pain in cheek bone, pain in neck.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) tired. On 11 Feb 2021, the patient experienced the events pain on her shoulder around her collar bone, pain in cheek bone, pain in neck.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tired, pain on her shoulder around her collar bone, pain in cheek bone, pain in neck was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Vaccination site pain
Clinical narrative: a wave went over my chest, then I got chest pain; fatigue; arm was really sore (inj site); A spontaneous report was received from a consumer concerning a 87-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, arm was really sore (inj site)/vaccination site pain, a wave went over  chest, then got chest pain.  The patient's medical history included COPD, leaky heart valves. No relevant concomitant medications were reported.  On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) fatigue, arm was really sore (inj site), a wave went over  chest, then igot chest pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fatigue, arm was really sore (inj site), a wave went over  chest, then  got chest pain was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: arm is red (injection site); arm is swollen (injection site); A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site swollen and redness  The patient's medical history was not provided. Concomitant medications were not provided.  On 25 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event injection site redness and swollen.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, injection site redness and swollen were  unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Dizziness
Clinical narrative: stomachache ( ever time she eat); diarrhea,; dizziness (she fell very weak); arm sore a little; fell very weak/is weak; get sick very easy; thinking at they given the germ; felling tired.; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache ( ever time she eat)), DIARRHOEA (diarrhea,), DIZZINESS (dizziness (she fell very weak)), PAIN IN EXTREMITY (arm sore a little) and ASTHENIA (fell very weak/is weak) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 18-Jan-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) dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomachache ( ever time she eat)), DIARRHOEA (diarrhea,), DIZZINESS (dizziness (she fell very weak)), PAIN IN EXTREMITY (arm sore a little), ASTHENIA (fell very weak/is weak), ILLNESS (get sick very easy), VACCINATION COMPLICATION (thinking at they given the germ), FATIGUE (felling tired.) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN UPPER (stomachache ( ever time she eat)), DIARRHOEA (diarrhea,), DIZZINESS (dizziness (she fell very weak)), PAIN IN EXTREMITY (arm sore a little), ASTHENIA (fell very weak/is weak), ILLNESS (get sick very easy), VACCINATION COMPLICATION (thinking at they given the germ), FATIGUE (felling tired.) and CHILLS (chills) outcome was unknown.            Tx: try not to. Only Advilin liquid.   This case was linked to MOD-2021-021692 (E2B Linked Report).; Sender's Comments:  MOD-2021-021692:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Pain in extremity, Vaccination complication
Clinical narrative: stomachache ( ever time she eat); diarrhea,; dizziness (she fell very weak); arm sore a little; fell very weak/is weak; get sick very easy; thinking at they given the germ; felling tired.; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache ( ever time she eat)), DIARRHOEA (diarrhea,), DIZZINESS (dizziness (she fell very weak)), PAIN IN EXTREMITY (arm sore a little) and ASTHENIA (fell very weak/is weak) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 18-Jan-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) dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomachache ( ever time she eat)), DIARRHOEA (diarrhea,), DIZZINESS (dizziness (she fell very weak)), PAIN IN EXTREMITY (arm sore a little), ASTHENIA (fell very weak/is weak), ILLNESS (get sick very easy), VACCINATION COMPLICATION (thinking at they given the germ), FATIGUE (felling tired.) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN UPPER (stomachache ( ever time she eat)), DIARRHOEA (diarrhea,), DIZZINESS (dizziness (she fell very weak)), PAIN IN EXTREMITY (arm sore a little), ASTHENIA (fell very weak/is weak), ILLNESS (get sick very easy), VACCINATION COMPLICATION (thinking at they given the germ), FATIGUE (felling tired.) and CHILLS (chills) outcome was unknown.            Tx: try not to. Only Advilin liquid.   This case was linked to MOD-2021-021692 (E2B Linked Report).; Sender's Comments:  MOD-2021-021692:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Night sweats, Pyrexia, Terminal insomnia
Clinical narrative: having night sweats; waking up in the middle of the night drenched; fatigued; fever of 104 degrees; A spontaneous report was received from a consumer concerning a 37-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever of 104 degrees, having night sweats, waking up in the middle of the night drenched, fatigued.  The patient's medical history was not provided. Concomitant medications reported were Topamax, Paxil for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unkown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the events fever of 104 degrees. On an unknown date, the patient experienced the events having night sweats, waking up in the middle of the night drenched, fatigued.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, fever of 104 degrees, having night sweats, waking up in the middle of the night drenched, fatigued was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Mobility decreased, Pain
Clinical narrative: flu-like symptoms; aches; hives; can't move arm; itching; rash throughout body (upper back, left breast, leg); injection site pain; injection site redness; injection site sore red knot; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (aches), URTICARIA (hives), MOBILITY DECREASED (can't move arm) and PRURITUS (itching) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Drug allergy. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), SALBUTAMOL (ALBUTEROL HFA), NYSTATIN, HCTZ, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FAMOTIDINE (PEPCID AC), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and MACROGOL 3350 (MIRALAX) for an unknown indication.    On 04-Feb-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 INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (aches), URTICARIA (hives), MOBILITY DECREASED (can't move arm), PRURITUS (itching), RASH (rash throughout body (upper back, left breast, leg)), INJECTION SITE PAIN (injection site pain), INJECTION SITE ERYTHEMA (injection site redness), VACCINATION SITE PAIN (injection site sore red knot) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (aches), URTICARIA (hives), MOBILITY DECREASED (can't move arm), PRURITUS (itching), RASH (rash throughout body (upper back, left breast, leg)), INJECTION SITE PAIN (injection site pain), INJECTION SITE ERYTHEMA (injection site redness), VACCINATION SITE PAIN (injection site sore red knot) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR received contains no new informations
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Urticaria, Vaccination site pain
Clinical narrative: flu-like symptoms; aches; hives; can't move arm; itching; rash throughout body (upper back, left breast, leg); injection site pain; injection site redness; injection site sore red knot; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (aches), URTICARIA (hives), MOBILITY DECREASED (can't move arm) and PRURITUS (itching) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Drug allergy. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), SALBUTAMOL (ALBUTEROL HFA), NYSTATIN, HCTZ, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FAMOTIDINE (PEPCID AC), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and MACROGOL 3350 (MIRALAX) for an unknown indication.    On 04-Feb-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 INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (aches), URTICARIA (hives), MOBILITY DECREASED (can't move arm), PRURITUS (itching), RASH (rash throughout body (upper back, left breast, leg)), INJECTION SITE PAIN (injection site pain), INJECTION SITE ERYTHEMA (injection site redness), VACCINATION SITE PAIN (injection site sore red knot) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (aches), URTICARIA (hives), MOBILITY DECREASED (can't move arm), PRURITUS (itching), RASH (rash throughout body (upper back, left breast, leg)), INJECTION SITE PAIN (injection site pain), INJECTION SITE ERYTHEMA (injection site redness), VACCINATION SITE PAIN (injection site sore red knot) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: TCR received contains no new informations
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hot at the injection site; Itchy at site of injection; Arm is sore - left arm / sore to touch at the injection site; Arm is swollen - left arm; Rash at site of injection; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE PAIN (Arm is sore - left arm / sore to touch at the injection site), VACCINATION SITE SWELLING (Arm is swollen - left arm) and VACCINATION SITE RASH (Rash at site of injection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-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 WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE PAIN (Arm is sore - left arm / sore to touch at the injection site), VACCINATION SITE SWELLING (Arm is swollen - left arm) and VACCINATION SITE RASH (Rash at site of injection). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (topical) for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE PRURITUS (Itchy at site of injection), VACCINATION SITE PAIN (Arm is sore - left arm / sore to touch at the injection site), VACCINATION SITE SWELLING (Arm is swollen - left arm) and VACCINATION SITE RASH (Rash at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-Jun-2021 , contains non significant information. Reporter contact number, patient information on race and ethnic group was updated .
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after vaccination) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID after vaccination). At the time of the report, COVID-19 (Tested positive for COVID after vaccination) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: developed a fever that went away eventually; A spontaneous report (United States) was received from a healthcare professional concerning a 59-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events developed a fever that went away eventually.  The patient's medical history included COVID 19. Concomitant medications reported were Gabapentin for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) developed a fever that went away eventually.  Treatment details included Acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.  On 11 Feb 2021 the outcome of event(s), developed a fever that went away eventually was resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash, Sunburn, Vaccination site erythema
Clinical narrative: Sunburn like feeling; Itching; hot to touch; Rash Spreading; Redness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of SUNBURN (Sunburn like feeling), PRURITUS (Itching), FEELING HOT (hot to touch), RASH (Rash Spreading) and VACCINATION SITE ERYTHEMA (Redness on injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SUNBURN (Sunburn like feeling), PRURITUS (Itching), FEELING HOT (hot to touch), RASH (Rash Spreading) and VACCINATION SITE ERYTHEMA (Redness on injection site). At the time of the report, SUNBURN (Sunburn like feeling), PRURITUS (Itching), FEELING HOT (hot to touch), RASH (Rash Spreading) and VACCINATION SITE ERYTHEMA (Redness on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment details included Lubricants on affected site.