chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Memory impairment, Pharyngeal swelling, Rash
Clinical narrative: Felt miserable; up and down blood pressure; difficulty breathing/shortness of breath; swelling of the throat; dizziness; weakness; memory would come and go; rash all over her body; headache; swelling of the glands; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt miserable), BLOOD PRESSURE FLUCTUATION (up and down blood pressure), DYSPNOEA (difficulty breathing/shortness of breath), PHARYNGEAL SWELLING (swelling of the throat) and DIZZINESS (dizziness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson COVID-19 Vaccine (The vaccine was given by Intramuscular route and anatomical approach site is left deltoid. Lot and expiration date unknown.) on 09-May-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID-19 Vaccine. Concurrent medical conditions included Hypertension.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Nov-2021, the patient experienced FEELING ABNORMAL (Felt miserable), BLOOD PRESSURE FLUCTUATION (up and down blood pressure), DYSPNOEA (difficulty breathing/shortness of breath), PHARYNGEAL SWELLING (swelling of the throat), DIZZINESS (dizziness), ASTHENIA (weakness), MEMORY IMPAIRMENT (memory would come and go), RASH (rash all over her body), HEADACHE (headache) and LYMPHADENOPATHY (swelling of the glands). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Felt miserable), BLOOD PRESSURE FLUCTUATION (up and down blood pressure), DYSPNOEA (difficulty breathing/shortness of breath), PHARYNGEAL SWELLING (swelling of the throat), DIZZINESS (dizziness), ASTHENIA (weakness), MEMORY IMPAIRMENT (memory would come and go), HEADACHE (headache) and LYMPHADENOPATHY (swelling of the glands) was resolving and RASH (rash all over her body) had not resolved.            Concomitant product code is given has blood pressure medication and description is given has Once daily.  Patient stated she did not have a fast heartbeat.  On 10 NOV 2021, Patient reported she still has the rash but it is not as bad.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Neck pain, Pyrexia, Vaccination site pain
Clinical narrative: Neck hurts; Arm hurts really bad; Chills; Fever; Body ache; This spontaneous case was reported by a nurse and describes the occurrence of NECK PAIN (Neck hurts), VACCINATION SITE PAIN (Arm hurts really bad), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced NECK PAIN (Neck hurts), VACCINATION SITE PAIN (Arm hurts really bad), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache). The patient was treated with IBUPROFEN for Ache, at a dose of 800 mg. At the time of the report, NECK PAIN (Neck hurts), VACCINATION SITE PAIN (Arm hurts really bad), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: left upper arm was swollen (double its size); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left upper arm was swollen (double its size)) 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.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced PERIPHERAL SWELLING (left upper arm was swollen (double its size)). At the time of the report, PERIPHERAL SWELLING (left upper arm was swollen (double its size)) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Ear pain, Headache
Clinical narrative: pains everywhere; ear pain; back pain; rib pain; joint pain; body pain; fever of 100 to 101 degrees Farenheight.; headaches; feels like we have the Covid-19 virus again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains everywhere), EAR PAIN (ear pain), BACK PAIN (back pain), MUSCULOSKELETAL CHEST PAIN (rib pain) and ARTHRALGIA (joint pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2021.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced PAIN (pains everywhere), EAR PAIN (ear pain), BACK PAIN (back pain), MUSCULOSKELETAL CHEST PAIN (rib pain), ARTHRALGIA (joint pain), MYALGIA (body pain), PYREXIA (fever of 100 to 101 degrees Farenheight.), HEADACHE (headaches) and SUSPECTED COVID-19 (feels like we have the Covid-19 virus again). At the time of the report, PAIN (pains everywhere), EAR PAIN (ear pain), BACK PAIN (back pain), MUSCULOSKELETAL CHEST PAIN (rib pain), ARTHRALGIA (joint pain), MYALGIA (body pain), PYREXIA (fever of 100 to 101 degrees Farenheight.), HEADACHE (headaches) and SUSPECTED COVID-19 (feels like we have the Covid-19 virus again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, Body temperature: 100-101 (High) 100 to 101 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.  This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history, who experienced non serious, AESI, unexpected event of Suspected COVID-19. The event occurred 2 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history, who experienced non serious, AESI, unexpected event of Suspected COVID-19. The event occurred 2 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Myalgia, Pain, Pyrexia, Suspected COVID-19
Clinical narrative: pains everywhere; ear pain; back pain; rib pain; joint pain; body pain; fever of 100 to 101 degrees Farenheight.; headaches; feels like we have the Covid-19 virus again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains everywhere), EAR PAIN (ear pain), BACK PAIN (back pain), MUSCULOSKELETAL CHEST PAIN (rib pain) and ARTHRALGIA (joint pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2021.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced PAIN (pains everywhere), EAR PAIN (ear pain), BACK PAIN (back pain), MUSCULOSKELETAL CHEST PAIN (rib pain), ARTHRALGIA (joint pain), MYALGIA (body pain), PYREXIA (fever of 100 to 101 degrees Farenheight.), HEADACHE (headaches) and SUSPECTED COVID-19 (feels like we have the Covid-19 virus again). At the time of the report, PAIN (pains everywhere), EAR PAIN (ear pain), BACK PAIN (back pain), MUSCULOSKELETAL CHEST PAIN (rib pain), ARTHRALGIA (joint pain), MYALGIA (body pain), PYREXIA (fever of 100 to 101 degrees Farenheight.), HEADACHE (headaches) and SUSPECTED COVID-19 (feels like we have the Covid-19 virus again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, Body temperature: 100-101 (High) 100 to 101 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.  This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history, who experienced non serious, AESI, unexpected event of Suspected COVID-19. The event occurred 2 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history, who experienced non serious, AESI, unexpected event of Suspected COVID-19. The event occurred 2 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Nausea, Pain
Clinical narrative: Soreness; Flu like symptoms; Fever; Chills; Tiredness; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nauseas). At the time of the report, PAIN (Soreness), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nauseas) outcome was unknown.            No treatment medications were provided. No concomitant medications were provided.  Patient got sick following vaccination with the booster dose of the Moderna COVID-19 vaccine and experienced the following: fever, chills, tiredness, soreness, nauseas and flu like symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received with no new information.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Soreness; Flu like symptoms; Fever; Chills; Tiredness; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Tiredness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nauseas). At the time of the report, PAIN (Soreness), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Tiredness) and NAUSEA (Nauseas) outcome was unknown.            No treatment medications were provided. No concomitant medications were provided.  Patient got sick following vaccination with the booster dose of the Moderna COVID-19 vaccine and experienced the following: fever, chills, tiredness, soreness, nauseas and flu like symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received with no new information.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose past manufacturer expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose past manufacturer expiration date) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose past manufacturer expiration date). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose past manufacturer expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow-up received: Patient demographic and dose details were updated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Loss of personal independence in daily activities, Lymphadenopathy, Memory impairment
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Forgetting things at work/ Foggy brain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interrupted her daily activities), LYMPHADENOPATHY (Swollen lymph nodes in the neck and groin area), CHILLS (Bad chills) and FATIGUE (Very tired) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 059E21A) for COVID-19 vaccination.     The patient's past medical history included Hormone replacement therapy (Patient currently is on hormonal replacement therapy.) since an unknown date. Concurrent medical conditions included Endometriosis, Chronic UTI, Chronic migraine and Sulfonamide allergy (Sulfa allergy).   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-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 MEMORY IMPAIRMENT (Forgetting things at work/ Foggy brain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interrupted her daily activities), LYMPHADENOPATHY (Swollen lymph nodes in the neck and groin area), CHILLS (Bad chills) and FATIGUE (Very tired). At the time of the report, MEMORY IMPAIRMENT (Forgetting things at work/ Foggy brain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Interrupted her daily activities), LYMPHADENOPATHY (Swollen lymph nodes in the neck and groin area), CHILLS (Bad chills) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications were reported.  After second dose, patient started to forgetting things at work and have foggy brain which interrupted daily activities. The patient had bad chills, very tired, swollen lymph nodes in the neck and groin area.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired Moderna vaccine/dose given to patient after expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna vaccine/dose given to patient after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna vaccine/dose given to patient after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna vaccine/dose given to patient after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 10-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021). On 10-Nov-2021, PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Impaired work ability, Malaise, Nausea
Clinical narrative: generally ill; had to leave work; dizzy; nauseous; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (generally ill), IMPAIRED WORK ABILITY (had to leave work), DIZZINESS (dizzy) and NAUSEA (nauseous) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 028L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced MALAISE (generally ill), IMPAIRED WORK ABILITY (had to leave work), DIZZINESS (dizzy) and NAUSEA (nauseous). At the time of the report, MALAISE (generally ill), IMPAIRED WORK ABILITY (had to leave work), DIZZINESS (dizzy) and NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter.  No treatment information provided   This case was linked to MOD-2021-383276 (Patient Link).
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021.) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) 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 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021.). On 10-Nov-2021, PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not provided.
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product administration error
Clinical narrative: Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 25-Mar-2021, the patient started COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) at an unspecified dose. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021). On 10-Nov-2021, PRODUCT ADMINISTRATION ERROR (Rather than drawing 20 doses, they drew 24 doses and administered those 24 doses today 10Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 24 doses drawn from one vial and administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (24 doses drawn from one vial and administered) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION ERROR (24 doses drawn from one vial and administered). On 10-Nov-2021, PRODUCT ADMINISTRATION ERROR (24 doses drawn from one vial and administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired dose past manufacturer expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose past manufacturer expiration date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose past manufacturer expiration date). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received expired dose past manufacturer expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided. No concomitant medication was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Left arm injection site has a big red lump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Left arm injection site has a big red lump) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 032M20A and 010M20A) for COVID-19 vaccination.     Previously administered products included for Flu: flu vaccine (a day later she  was fine), flu vaccine (a day later she  was fine) and flu vaccine (a day later she  was fine). Past adverse reactions to the above products included Cold with flu vaccine; Dizzy with flu vaccine; and Feeling hot with flu vaccine.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced VACCINATION SITE MASS (Left arm injection site has a big red lump). At the time of the report, VACCINATION SITE MASS (Left arm injection site has a big red lump) had not resolved.            Patient States that she takes "many medications" as concomitant medications & declined to provide. No Treatment Information were provided by the reporter
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dysstasia, Impaired driving ability, Pyrexia
Clinical narrative: couldn't stand up and had to lay down.; she was very dizzy; couldn't drive her car; Pains in all of her joints; Felt as if she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (couldn't stand up and had to lay down.), DIZZINESS (she was very dizzy), IMPAIRED DRIVING ABILITY (couldn't drive her car), ARTHRALGIA (Pains in all of her joints) and PYREXIA (Felt as if she had a fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F214, 013M20A and 032L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Right arm). Past adverse reactions to the above products included No adverse event with Flu shot.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third 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 09-Nov-2021, the patient experienced DYSSTASIA (couldn't stand up and had to lay down.), DIZZINESS (she was very dizzy), IMPAIRED DRIVING ABILITY (couldn't drive her car), ARTHRALGIA (Pains in all of her joints) and PYREXIA (Felt as if she had a fever). At the time of the report, DYSSTASIA (couldn't stand up and had to lay down.), DIZZINESS (she was very dizzy), IMPAIRED DRIVING ABILITY (couldn't drive her car), ARTHRALGIA (Pains in all of her joints) and PYREXIA (Felt as if she had a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. On 08-Nov-2021, the vial was initially stored in the refrigerator.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Vaccination complication
Clinical narrative: Severe reaction; Body aches; Throwing up; Tired; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (Severe reaction), MYALGIA (Body aches), NAUSEA (Throwing up) and FATIGUE (Tired) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 02-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 COMPLICATION (Severe reaction), MYALGIA (Body aches), NAUSEA (Throwing up) and FATIGUE (Tired). At the time of the report, VACCINATION COMPLICATION (Severe reaction), MYALGIA (Body aches), NAUSEA (Throwing up) and FATIGUE (Tired) 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 medications were not provided Treatment medications were not provided  It was reported that post first dose patient experienced severe reaction  and patient wanted to try another manufacture vaccine other than moderna vaccine.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: they know people that got sick (with COVID) after being vaccinated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (they know people that got sick (with COVID) after being vaccinated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (they know people that got sick (with COVID) after being vaccinated). At the time of the report, COVID-19 (they know people that got sick (with COVID) after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment : This case concerns a patient of unknown age nor gender with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred at an unknown date after the mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable. This is an invalid case since the reporter states that an unknown number of people got sick (with COVID) after being vaccinated. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Caller stated that he does not know that Moderna vaccine or not. Unknown manufacturer.  No treatment details provided. No concomitant medications were reported.; Sender's Comments: This case concerns a patient of unknown age nor gender with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred at an unknown date after the mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable. This is an invalid case since the reporter states that an unknown number of people got sick (with COVID) after being vaccinated. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04220A, 024m20A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial initial storage date in refrigerator was 08-Nov-2021. Vials did not undergo any temperature excursion.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: 1st dose- Pfizer- 24Jan2021,2nd dose- Moderna- 08Nov2021; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st dose- Pfizer- 24Jan2021,2nd dose- Moderna- 08Nov2021) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer (transported to hospital) on 24-Jan-2021. Past adverse reactions to the above products included Adverse reaction with Pfizer.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st dose- Pfizer- 24Jan2021,2nd dose- Moderna- 08Nov2021). On 08-Nov-2021, INTERCHANGE OF VACCINE PRODUCTS (1st dose- Pfizer- 24Jan2021,2nd dose- Moderna- 08Nov2021) had resolved.            No concomitant medication was provided. No treatment information was provided.  It was reported that, 1st dose Pfizer Lot Number EL3247.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 08-Nov-2021, the vial was initially stored in the refrigerator. It was stated that, there were 36 doses per vials and the vial did not undergo any temperature excursions.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-380380 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-380380:master case
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Knows someone have similar side effect as hers (lower leg numbness); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Knows someone have similar side effect as hers (lower leg numbness)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Knows someone have similar side effect as hers (lower leg numbness)). At the time of the report, HYPOAESTHESIA (Knows someone have similar side effect as hers (lower leg numbness)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and medication information provided.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported