chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old and received the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose). On 22-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose) had resolved. Not Provided      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. Treatment information was not provided.    This case was linked to MOD-2021-090234, MOD-2021-228590 (Patient Link).
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old and received the 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old and received the 1st dose) outcome was unknown. Not Provided      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 relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed to receive the 2nd dose of Moderna vaccine 65 days; 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 PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine 65 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine 65 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed to receive the 2nd dose of Moderna vaccine 65 days) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Who should I talk to if I get "covid arm"?; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Who should I talk to if I get "covid arm"?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Who should I talk to if I get "covid arm"?). At the time of the report, PAIN IN EXTREMITY (Who should I talk to if I get "covid arm"?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported  Treatment medication was not reported
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Skin burning sensation
Clinical narrative: skin burn when I touch it; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (skin burn when I touch it) and INFLUENZA LIKE ILLNESS (flu like symptoms) 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 SKIN BURNING SENSATION (skin burn when I touch it) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, SKIN BURNING SENSATION (skin burn when I touch it) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chills, Pain in extremity
Clinical narrative: abdomen is swollen; sore arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (abdomen is swollen), PAIN IN EXTREMITY (sore arm) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Post COVID syndrome is inflammatory and patient had mild COVID sore throat.) in November 2020. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin allergy causes rash.) since 2015.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced ABDOMINAL DISTENSION (abdomen is swollen), PAIN IN EXTREMITY (sore arm) and CHILLS (chills). The patient was treated with PREDNISONE (oral) from 21-Feb-2021 to 03-Mar-2021 at a dose of 10 mg. At the time of the report, ABDOMINAL DISTENSION (abdomen is swollen) was resolving and PAIN IN EXTREMITY (sore arm) and CHILLS (chills) had resolved.            No concomitant medication was given. The patient reported that after taking prednisone everything get cleared but still abdomen is swollen. No laboratory data was provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Heart rate, Rash, Rash erythematous
Clinical narrative: it is like a measles-like rash; a little bit warm to the touch; it looks like a sunburn; small red dots at closer inspection; a bad headache; a rash on his torso appeared,a rash on his upper back appeared; This spontaneous case was reported by a patient and describes the occurrence of RASH MORBILLIFORM (it is like a measles-like rash), FEELING HOT (a little bit warm to the touch), SUNBURN (it looks like a sunburn), RASH ERYTHEMATOUS (small red dots at closer inspection) and HEADACHE (a bad headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rash in 2019. Previously administered products included for an unreported indication: SHINGRIX (Shingles vaccine) in 2019. Concurrent medical conditions included Allergy NOS. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced RASH MORBILLIFORM (it is like a measles-like rash), FEELING HOT (a little bit warm to the touch), SUNBURN (it looks like a sunburn), RASH ERYTHEMATOUS (small red dots at closer inspection), HEADACHE (a bad headache) and RASH (a rash on his torso appeared,a rash on his upper back appeared). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (BABY ASPIRIN) on 18-Jun-2021 at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 18-Jun-2021 for Allergy, at an unspecified dose and frequency. At the time of the report, RASH MORBILLIFORM (it is like a measles-like rash), FEELING HOT (a little bit warm to the touch), SUNBURN (it looks like a sunburn), RASH ERYTHEMATOUS (small red dots at closer inspection), HEADACHE (a bad headache) and RASH (a rash on his torso appeared,a rash on his upper back appeared) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 120 (High) High.         Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-JUN-2021 and included No new information
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Rash morbilliform, Sunburn
Clinical narrative: it is like a measles-like rash; a little bit warm to the touch; it looks like a sunburn; small red dots at closer inspection; a bad headache; a rash on his torso appeared,a rash on his upper back appeared; This spontaneous case was reported by a patient and describes the occurrence of RASH MORBILLIFORM (it is like a measles-like rash), FEELING HOT (a little bit warm to the touch), SUNBURN (it looks like a sunburn), RASH ERYTHEMATOUS (small red dots at closer inspection) and HEADACHE (a bad headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rash in 2019. Previously administered products included for an unreported indication: SHINGRIX (Shingles vaccine) in 2019. Concurrent medical conditions included Allergy NOS. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced RASH MORBILLIFORM (it is like a measles-like rash), FEELING HOT (a little bit warm to the touch), SUNBURN (it looks like a sunburn), RASH ERYTHEMATOUS (small red dots at closer inspection), HEADACHE (a bad headache) and RASH (a rash on his torso appeared,a rash on his upper back appeared). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (BABY ASPIRIN) on 18-Jun-2021 at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 18-Jun-2021 for Allergy, at an unspecified dose and frequency. At the time of the report, RASH MORBILLIFORM (it is like a measles-like rash), FEELING HOT (a little bit warm to the touch), SUNBURN (it looks like a sunburn), RASH ERYTHEMATOUS (small red dots at closer inspection), HEADACHE (a bad headache) and RASH (a rash on his torso appeared,a rash on his upper back appeared) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 120 (High) High.         Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-JUN-2021 and included No new information
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: punctured vial that was used on the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (punctured vial that was used on the patient) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for an unknown indication.     Concurrent medical conditions included Diabetes. Concomitant products included EMPAGLIFLOZIN (JARDIANCE) for Diabetes, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), SPIRONOLACTONE, ATORVASTATIN, CARVEDILOL and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (punctured vial that was used on the patient). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (punctured vial that was used on the patient) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported.
Age: 67.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rash, Vaccination site nodule, Vaccination site pain
Clinical narrative: Vaccination site nodule; rash; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Vaccination site nodule), RASH (rash) and VACCINATION SITE PAIN (Vaccination site pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (Vaccination site nodule), RASH (rash) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE NODULE (Vaccination site nodule), RASH (rash) and VACCINATION SITE PAIN (Vaccination site pain) 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 provided by the reporter.  No treatment information was provided by the reporter.  No Lab data was provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site arm hurt) in a male 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced VACCINATION SITE PAIN (injection site arm hurt). At the time of the report, VACCINATION SITE PAIN (injection site arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-228407, MOD-2021-228505 (E2B Linked Report).; Sender's Comments:  MOD-2021-228407:Patient-Brother link case MOD-2021-228505:Patient Case
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling in the left arm; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Swelling in the left arm) 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 PERIPHERAL SWELLING (Swelling in the left arm). At the time of the report, PERIPHERAL SWELLING (Swelling in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Hearing a horn or beeping sounds like things like he has been exposed to loud noise/sound.; Headache,having extreme headache.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Hearing a horn or beeping sounds like things like he has been exposed to loud noise/sound.) and HEADACHE (Headache,having extreme headache.) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A (could be 025821A) and 036A21A) 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) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Hearing a horn or beeping sounds like things like he has been exposed to loud noise/sound.) and HEADACHE (Headache,having extreme headache.). The patient was treated with IBUPROFEN for Headache and Ear ringing, at an unspecified dose and frequency and IBUPROFEN for Headache and Ear ringing, at a dose of 1 dosage form. At the time of the report, TINNITUS (Hearing a horn or beeping sounds like things like he has been exposed to loud noise/sound.) and HEADACHE (Headache,having extreme headache.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received included severity of event were updated.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient given both doses over two days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient given both doses over two days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient given both doses over two days). On 17-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient given both doses over two days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: clarification on dosing received, Patient only got first dose on 17-JUL-2021, no previous dose.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Hypersensitivity to vaccine (not sure); Severe rash on his both arms; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity to vaccine (not sure)) and RASH (Severe rash on his both arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitivity to vaccine (not sure)) and RASH (Severe rash on his both arms). At the time of the report, HYPERSENSITIVITY (Hypersensitivity to vaccine (not sure)) and RASH (Severe rash on his both arms) 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 by the reporter.  Treatment information was not provided.  .   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain, Pyrexia
Clinical narrative: minor sore throat; have a minor fever,; some muscle fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (minor sore throat), PYREXIA (have a minor fever,) and FATIGUE (some muscle fatigue) 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 OROPHARYNGEAL PAIN (minor sore throat), PYREXIA (have a minor fever,) and FATIGUE (some muscle fatigue). At the time of the report, OROPHARYNGEAL PAIN (minor sore throat), PYREXIA (have a minor fever,) and FATIGUE (some muscle fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided, No concomitant medication reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient did not receive second dose of the Moderna COVID-19 vaccine (first dose 19FEB2021).; This spontaneous case was reported by a pharmacist and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Patient did not receive second dose of the Moderna COVID-19 vaccine (first dose 19FEB2021).) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Patient did not receive second dose of the Moderna COVID-19 vaccine (first dose 19FEB2021).). At the time of the report, INCOMPLETE COURSE OF VACCINATION (Patient did not receive second dose of the Moderna COVID-19 vaccine (first dose 19FEB2021).) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I tested positive, diagnosis after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I tested positive, diagnosis after vaccination) 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.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I tested positive, diagnosis after vaccination). At the time of the report, COVID-19 (I tested positive, diagnosis after vaccination) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) positive.         Concomitant medications were not provided by the reporter. Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore after first dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore after first dose). At the time of the report, PAIN IN EXTREMITY (Arm was sore after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-228969 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine had been punctured for 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours). On 17-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine had been punctured for 26 hours) had resolved. Not Provided      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 Concomitant medications were reported. No treatment medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Headache, Myalgia, Pain in extremity
Clinical narrative: Very cold; Was having body aches; headaches; Fever; Pain in both shoulders; Pain in the hand/Pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the hand/Pain in the left arm), FEELING COLD (Very cold), ARTHRALGIA (Pain in both shoulders), MYALGIA (Was having body aches) and HEADACHE (headaches) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced PAIN IN EXTREMITY (Pain in the hand/Pain in the left arm) and ARTHRALGIA (Pain in both shoulders). On 18-Jun-2021, the patient experienced FEELING COLD (Very cold), MYALGIA (Was having body aches), HEADACHE (headaches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in the hand/Pain in the left arm), FEELING COLD (Very cold), MYALGIA (Was having body aches) and HEADACHE (headaches) had not resolved and ARTHRALGIA (Pain in both shoulders) and PYREXIA (Fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Aspirin 81 was used as an Anticoagulant medication. Asthma medication (unknown) was reported by the reporter.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Very cold; Was having body aches; headaches; Fever; Pain in both shoulders; Pain in the hand/Pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the hand/Pain in the left arm), FEELING COLD (Very cold), ARTHRALGIA (Pain in both shoulders), MYALGIA (Was having body aches) and HEADACHE (headaches) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced PAIN IN EXTREMITY (Pain in the hand/Pain in the left arm) and ARTHRALGIA (Pain in both shoulders). On 18-Jun-2021, the patient experienced FEELING COLD (Very cold), MYALGIA (Was having body aches), HEADACHE (headaches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in the hand/Pain in the left arm), FEELING COLD (Very cold), MYALGIA (Was having body aches) and HEADACHE (headaches) had not resolved and ARTHRALGIA (Pain in both shoulders) and PYREXIA (Fever) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Aspirin 81 was used as an Anticoagulant medication. Asthma medication (unknown) was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Candida infection, Fordyce spots, Lip swelling, Pain, Pharyngeal swelling
Clinical narrative: swollen lips; swollen tongue; swollen throat; little white bumps on the inside of my bottom lip; Ive had thrush before but never to this extent.; pain; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips), SWOLLEN TONGUE (swollen tongue), PHARYNGEAL SWELLING (swollen throat), FORDYCE SPOTS (little white bumps on the inside of my bottom lip) and CANDIDA INFECTION (Ive had thrush before but never to this extent.) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swollen lips), SWOLLEN TONGUE (swollen tongue), PHARYNGEAL SWELLING (swollen throat), FORDYCE SPOTS (little white bumps on the inside of my bottom lip), CANDIDA INFECTION (Ive had thrush before but never to this extent.) and PAIN (pain). At the time of the report, LIP SWELLING (swollen lips), SWOLLEN TONGUE (swollen tongue), PHARYNGEAL SWELLING (swollen throat), FORDYCE SPOTS (little white bumps on the inside of my bottom lip), CANDIDA INFECTION (Ive had thrush before but never to this extent.) and PAIN (pain) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: swollen lips; swollen tongue; swollen throat; little white bumps on the inside of my bottom lip; Ive had thrush before but never to this extent.; pain; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips), SWOLLEN TONGUE (swollen tongue), PHARYNGEAL SWELLING (swollen throat), FORDYCE SPOTS (little white bumps on the inside of my bottom lip) and CANDIDA INFECTION (Ive had thrush before but never to this extent.) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swollen lips), SWOLLEN TONGUE (swollen tongue), PHARYNGEAL SWELLING (swollen throat), FORDYCE SPOTS (little white bumps on the inside of my bottom lip), CANDIDA INFECTION (Ive had thrush before but never to this extent.) and PAIN (pain). At the time of the report, LIP SWELLING (swollen lips), SWOLLEN TONGUE (swollen tongue), PHARYNGEAL SWELLING (swollen throat), FORDYCE SPOTS (little white bumps on the inside of my bottom lip), CANDIDA INFECTION (Ive had thrush before but never to this extent.) and PAIN (pain) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red dot on my arm, where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red dot on my arm, where I got the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red dot on my arm, where I got the vaccine). At the time of the report, VACCINATION SITE ERYTHEMA (red dot on my arm, where I got the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Tongue disorder
Clinical narrative: Headache; Fatigue, didn't feel full strength back for 2 more days; Tongue felt thick; Throat felt like a slight sore throat; This spontaneous case was reported by a non-health professional and describes the occurrence of TONGUE DISORDER (Tongue felt thick), OROPHARYNGEAL PAIN (Throat felt like a slight sore throat), HEADACHE (Headache) and FATIGUE (Fatigue, didn't feel full strength back for 2 more days) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced TONGUE DISORDER (Tongue felt thick) and OROPHARYNGEAL PAIN (Throat felt like a slight sore throat). On an unknown date, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue, didn't feel full strength back for 2 more days). At the time of the report, TONGUE DISORDER (Tongue felt thick), OROPHARYNGEAL PAIN (Throat felt like a slight sore throat), HEADACHE (Headache) and FATIGUE (Fatigue, didn't feel full strength back for 2 more days) outcome was unknown.            No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-023308 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Body temperature, Chest discomfort, Dysgeusia, Feeling abnormal
Clinical narrative: Special reaction/Having a reaction; Slight fever; Headache; Discomfort in chest; Arm is sore; Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine; metal taste; Lost her voice; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine), DYSGEUSIA (metal taste), APHONIA (Lost her voice), CHEST DISCOMFORT (Discomfort in chest) and PAIN IN EXTREMITY (Arm is sore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced FEELING ABNORMAL (Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine), DYSGEUSIA (metal taste) and APHONIA (Lost her voice). On 18-Jun-2021, the patient experienced CHEST DISCOMFORT (Discomfort in chest), PAIN IN EXTREMITY (Arm is sore) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION COMPLICATION (Special reaction/Having a reaction) and PYREXIA (Slight fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine), DYSGEUSIA (metal taste), APHONIA (Lost her voice), CHEST DISCOMFORT (Discomfort in chest), PAIN IN EXTREMITY (Arm is sore), VACCINATION COMPLICATION (Special reaction/Having a reaction), PYREXIA (Slight fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2021, Body temperature: 102.2 (High) 102.2 Degrees F.         No Concomitant medications were reported.  The patient stated she took Tylenol and Ibuprofen per the HCP's recommendation but was advised not take together.   This case was linked to MOD-2021-228922 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: Special reaction/Having a reaction; Slight fever; Headache; Discomfort in chest; Arm is sore; Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine; metal taste; Lost her voice; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine), DYSGEUSIA (metal taste), APHONIA (Lost her voice), CHEST DISCOMFORT (Discomfort in chest) and PAIN IN EXTREMITY (Arm is sore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced FEELING ABNORMAL (Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine), DYSGEUSIA (metal taste) and APHONIA (Lost her voice). On 18-Jun-2021, the patient experienced CHEST DISCOMFORT (Discomfort in chest), PAIN IN EXTREMITY (Arm is sore) and HEADACHE (Headache). On an unknown date, the patient experienced VACCINATION COMPLICATION (Special reaction/Having a reaction) and PYREXIA (Slight fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Could feel it (vaccine) spreading up her neck, could feel it (vaccine) spreading up her chest, Could feel it (vaccine) spreading across the back,Could taste the vaccine), DYSGEUSIA (metal taste), APHONIA (Lost her voice), CHEST DISCOMFORT (Discomfort in chest), PAIN IN EXTREMITY (Arm is sore), VACCINATION COMPLICATION (Special reaction/Having a reaction), PYREXIA (Slight fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2021, Body temperature: 102.2 (High) 102.2 Degrees F.         No Concomitant medications were reported.  The patient stated she took Tylenol and Ibuprofen per the HCP's recommendation but was advised not take together.   This case was linked to MOD-2021-228922 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: 98.5 temp; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (98.5 temp) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (98.5 temp). At the time of the report, BODY TEMPERATURE INCREASED (98.5 temp) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-Up information received on 10-AUG-2021 included no new information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Peripheral swelling
Clinical narrative: burning sensation; swelling in her left arm; peripheral swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in her left arm), PERIPHERAL SWELLING (peripheral swelling) and BURNING SENSATION (burning sensation) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient Medical History was not provided.  Concomitant products included DUPILUMAB for Atopic dermatitis.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in her left arm). On an unknown date, the patient experienced PERIPHERAL SWELLING (peripheral swelling) and BURNING SENSATION (burning sensation). At the time of the report, PERIPHERAL SWELLING (swelling in her left arm), PERIPHERAL SWELLING (peripheral swelling) and BURNING SENSATION (burning sensation) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient iced and rubbed for swelling in her left arm that didn't go for 4 days then after one week  it returned .
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: had leg nervousness after taking the shot.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jun-2021 and was forwarded to Moderna on 18-Jun-2021.    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 LIMB DISCOMFORT (had leg nervousness after taking the shot.) 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 LIMB DISCOMFORT (had leg nervousness after taking the shot.). At the time of the report, LIMB DISCOMFORT (had leg nervousness after taking the shot.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Concomitant medication information were not provided.  The Treatment medication information  was not provided.    Reporter did not allow further contact