chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash pruritic, Vaccination site rash
Clinical narrative: broke out in rash/rash in left hand/rash across the breast/huge masses of red spots all over the body.; rash in left arm near the injection site; the rash as big blotchy red areas that itch; the rash as big blotchy red areas that itch; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (the rash as big blotchy red areas that itch), RASH PRURITIC (the rash as big blotchy red areas that itch), RASH (broke out in rash/rash in left hand/rash across the breast/huge masses of red spots all over the body.) and VACCINATION SITE RASH (rash in left arm near the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced RASH (broke out in rash/rash in left hand/rash across the breast/huge masses of red spots all over the body.). In July 2021, the patient experienced RASH MACULAR (the rash as big blotchy red areas that itch), RASH PRURITIC (the rash as big blotchy red areas that itch) and VACCINATION SITE RASH (rash in left arm near the injection site). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (the rash as big blotchy red areas that itch), RASH PRURITIC (the rash as big blotchy red areas that itch) and VACCINATION SITE RASH (rash in left arm near the injection site) outcome was unknown and RASH (broke out in rash/rash in left hand/rash across the breast/huge masses of red spots all over the body.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.   This case was linked to MOD-2021-297311 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Blister
Clinical narrative: On the armpit has a blister like with some fluid underneath it; On the armpit has a blister like with some fluid underneath it and is painful; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (On the armpit has a blister like with some fluid underneath it) and AXILLARY PAIN (On the armpit has a blister like with some fluid underneath it and is painful) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced BLISTER (On the armpit has a blister like with some fluid underneath it) and AXILLARY PAIN (On the armpit has a blister like with some fluid underneath it and is painful). At the time of the report, BLISTER (On the armpit has a blister like with some fluid underneath it) and AXILLARY PAIN (On the armpit has a blister like with some fluid underneath it and is painful) 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.   no concomitant medication and treatment medication was reported.  Patient reported that the patient was missing an opportunity of a lifetime due to this side effect.
Sex: U
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: tenderness by shot; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness by shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tenderness by shot). At the time of the report, TENDERNESS (tenderness by shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant informations were reported. No treatment informations were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nail discolouration, Pain in extremity, Petechiae
Clinical narrative: toenails & fingernails turned orange,on a few of her fingernails it looks like blood around the cuticles; her that the capillaries under her nails had burst,on a few of her fingernails it looks like blood around the cuticles; Her toes are worse; This spontaneous case was reported by a consumer and describes the occurrence of NAIL DISCOLOURATION (toenails & fingernails turned orange,on a few of her fingernails it looks like blood around the cuticles), PETECHIAE (her that the capillaries under her nails had burst,on a few of her fingernails it looks like blood around the cuticles) and PAIN IN EXTREMITY (Her toes are worse) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-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 NAIL DISCOLOURATION (toenails & fingernails turned orange,on a few of her fingernails it looks like blood around the cuticles), PETECHIAE (her that the capillaries under her nails had burst,on a few of her fingernails it looks like blood around the cuticles) and PAIN IN EXTREMITY (Her toes are worse). At the time of the report, NAIL DISCOLOURATION (toenails & fingernails turned orange,on a few of her fingernails it looks like blood around the cuticles), PETECHIAE (her that the capillaries under her nails had burst,on a few of her fingernails it looks like blood around the cuticles) and PAIN IN EXTREMITY (Her toes are worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment drug was reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: used a vial that was first punctured yesterday ( 26Aug2021 ) at 8:28 am; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (used a vial that was first punctured yesterday ( 26Aug2021 ) at 8:28 am) in a 34-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 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (used a vial that was first punctured yesterday ( 26Aug2021 ) at 8:28 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (used a vial that was first punctured yesterday ( 26Aug2021 ) at 8:28 am) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO concomitant medication was reported No treatment drug was reported   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow-up received on 31-AUG-2021: contains no new information
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain (body soreness) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jul 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 27, 2021, patient experienced pain (body soreness). At the time of the report, pain (body soreness) outcome: unknown. No concomitant medication or treatment information reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersensitivity, Nasopharyngitis, Pain, Pyrexia
Clinical narrative: Bad cold; Allergies really bad; second dose fever; second dose chills to the bones; second dose aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (second dose aches), NASOPHARYNGITIS (Bad cold), HYPERSENSITIVITY (Allergies really bad), PYREXIA (second dose fever) and CHILLS (second dose chills to the bones) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced PAIN (second dose aches), PYREXIA (second dose fever) and CHILLS (second dose chills to the bones). On 16-Jul-2021, the patient experienced NASOPHARYNGITIS (Bad cold) and HYPERSENSITIVITY (Allergies really bad). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (second dose aches), NASOPHARYNGITIS (Bad cold), PYREXIA (second dose fever) and CHILLS (second dose chills to the bones) outcome was unknown and HYPERSENSITIVITY (Allergies really bad) had not resolved.            Tylenol and Nyquil were provided as treatment medication   This case was linked to MOD-2021-300172, MOD-2021-300196 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up appended on 15- Nov-2021 No new information
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Lymphadenopathy, Muscle fatigue, Pain
Clinical narrative: aching to the bone; muscle fatigue; kidneys hurt; everything hurts, couldn't open car door; toes hurt; fever; Third dose caused chills; lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (aching to the bone), MUSCLE FATIGUE (muscle fatigue), RENAL PAIN (kidneys hurt), PAIN (everything hurts, couldn't open car door) and PAIN IN EXTREMITY (toes hurt) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced BONE PAIN (aching to the bone), MUSCLE FATIGUE (muscle fatigue), RENAL PAIN (kidneys hurt), PAIN (everything hurts, couldn't open car door), PAIN IN EXTREMITY (toes hurt), PYREXIA (fever), CHILLS (Third dose caused chills) and LYMPHADENOPATHY (lymph node swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, BONE PAIN (aching to the bone), MUSCLE FATIGUE (muscle fatigue), RENAL PAIN (kidneys hurt), PAIN (everything hurts, couldn't open car door), PAIN IN EXTREMITY (toes hurt), PYREXIA (fever), CHILLS (Third dose caused chills) and LYMPHADENOPATHY (lymph node swelling) outcome was unknown.            Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-300195, MOD-2021-300172 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received and does not contains any new information.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Renal pain
Clinical narrative: aching to the bone; muscle fatigue; kidneys hurt; everything hurts, couldn't open car door; toes hurt; fever; Third dose caused chills; lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (aching to the bone), MUSCLE FATIGUE (muscle fatigue), RENAL PAIN (kidneys hurt), PAIN (everything hurts, couldn't open car door) and PAIN IN EXTREMITY (toes hurt) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced BONE PAIN (aching to the bone), MUSCLE FATIGUE (muscle fatigue), RENAL PAIN (kidneys hurt), PAIN (everything hurts, couldn't open car door), PAIN IN EXTREMITY (toes hurt), PYREXIA (fever), CHILLS (Third dose caused chills) and LYMPHADENOPATHY (lymph node swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, BONE PAIN (aching to the bone), MUSCLE FATIGUE (muscle fatigue), RENAL PAIN (kidneys hurt), PAIN (everything hurts, couldn't open car door), PAIN IN EXTREMITY (toes hurt), PYREXIA (fever), CHILLS (Third dose caused chills) and LYMPHADENOPATHY (lymph node swelling) outcome was unknown.            Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-300195, MOD-2021-300172 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received and does not contains any new information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: More than 36 days since he got the first dose and still does not have the second; he has contracted COVID and tested positive; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (he has contracted COVID and tested positive) and PRODUCT DOSE OMISSION ISSUE (More than 36 days since he got the first dose and still does not have the second) 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 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced COVID-19 (he has contracted COVID and tested positive). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days since he got the first dose and still does not have the second). At the time of the report, COVID-19 (he has contracted COVID and tested positive) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 36 days since he got the first dose and still does not have the second) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID.     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.   It was stated that two days before he was due for his second dose. It was now been two weeks since he was  tested positive and he wants to come back and get his second dose.   No concomitant medication was reported. No treatment history was reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: more than 36 days for administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days for administration of second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days for administration of second dose). On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days for administration of second dose) had resolved.            Concomitant medications were not reported  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Non-significant Follow-up, contains reporter email address added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Myalgia, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (felt terrible), chills, myalgia (body aches all over) and nausea (nausea, the whole bit) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced feeling abnormal (felt terrible), chills, myalgia (body aches all over) and nausea (nausea, the whole bit). At the time of the report, feeling abnormal (felt terrible), chills, myalgia (body aches all over) and nausea (nausea, the whole bit) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (slight headache). At the time of the report, HEADACHE (slight headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD-2021-301429 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered the Moderna vaccine almost 20 hours after first puncture; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered the Moderna vaccine almost 20 hours after first puncture) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered the Moderna vaccine almost 20 hours after first puncture). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Administered the Moderna vaccine almost 20 hours after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (received expired dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 014C21A) for COVID-19 immunization. No medical history reported. On Aug 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Aug 30, 2021, patient experienced administered expired product (received expired dose). On Aug 30, 2021, administered expired product (received expired dose): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The nurse called to report 7 different patients received expired doses on Aug 30, 2021. The second patient received the dose as the first Moderna COVID-19 vaccine on Aug 30, 2021.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on the side; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the side) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on the side). At the time of the report, RASH (rash on the side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got the first 2 doses 22 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first 2 doses 22 days apart) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-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) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first 2 doses 22 days apart). On 16-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first 2 doses 22 days apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant mediations were reported.  No treatment medications were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: exhausted, fatigued; threw up; cold chills; vomiting; sweaty; diarrhea; nauseous; dizzy; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweaty), DIZZINESS (dizzy), DIARRHOEA (diarrhea), NAUSEA (nauseous) and CHILLS (cold chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Attention deficit hyperactivity disorder. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADHD, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and ATENOLOL for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). On 28-Aug-2021, the patient experienced HYPERHIDROSIS (sweaty), DIARRHOEA (diarrhea), CHILLS (cold chills) and VOMITING (vomiting). On 29-Aug-2021, the patient experienced VOMITING (threw up). On an unknown date, the patient experienced FATIGUE (exhausted, fatigued). At the time of the report, HYPERHIDROSIS (sweaty), DIZZINESS (dizzy), DIARRHOEA (diarrhea), NAUSEA (nauseous), CHILLS (cold chills), VOMITING (threw up), FATIGUE (exhausted, fatigued) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Blood pressure measurement: high (High) 172/108.     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.   Treatment medication includes Anti diarrheal medication  Patient crapped her pants
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: exhausted, fatigued; threw up; cold chills; vomiting; sweaty; diarrhea; nauseous; dizzy; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERHIDROSIS (sweaty), DIZZINESS (dizzy), DIARRHOEA (diarrhea), NAUSEA (nauseous) and CHILLS (cold chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Attention deficit hyperactivity disorder. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADHD, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and ATENOLOL for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced DIZZINESS (dizzy) and NAUSEA (nauseous). On 28-Aug-2021, the patient experienced HYPERHIDROSIS (sweaty), DIARRHOEA (diarrhea), CHILLS (cold chills) and VOMITING (vomiting). On 29-Aug-2021, the patient experienced VOMITING (threw up). On an unknown date, the patient experienced FATIGUE (exhausted, fatigued). At the time of the report, HYPERHIDROSIS (sweaty), DIZZINESS (dizzy), DIARRHOEA (diarrhea), NAUSEA (nauseous), CHILLS (cold chills), VOMITING (threw up), FATIGUE (exhausted, fatigued) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Blood pressure measurement: high (High) 172/108.     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.   Treatment medication includes Anti diarrheal medication  Patient crapped her pants
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site erythema, Vaccination site rash
Clinical narrative: breaking out in hives/Hives are all over, arms, legs, stomach, neck, but mainly in the arms; hives are itchy; red rash is just a little tender; red rash on the injection site; red rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out in hives/Hives are all over, arms, legs, stomach, neck, but mainly in the arms), PRURITUS (hives are itchy), RASH (red rash is just a little tender), VACCINATION SITE RASH (red rash on the injection site) and VACCINATION SITE ERYTHEMA (red rash on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced URTICARIA (breaking out in hives/Hives are all over, arms, legs, stomach, neck, but mainly in the arms), PRURITUS (hives are itchy), RASH (red rash is just a little tender), VACCINATION SITE RASH (red rash on the injection site) and VACCINATION SITE ERYTHEMA (red rash on the injection site). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (breaking out in hives/Hives are all over, arms, legs, stomach, neck, but mainly in the arms), PRURITUS (hives are itchy), RASH (red rash is just a little tender), VACCINATION SITE RASH (red rash on the injection site) and VACCINATION SITE ERYTHEMA (red rash on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  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.; 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Low graded fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low graded fever) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02F21A, 015M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced HEADACHE (Headache). On 30-Aug-2021, the patient experienced PYREXIA (Low graded fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 tylenol, around midnight. At the time of the report, PYREXIA (Low graded fever) and HEADACHE (Headache) had not resolved.            The concomitant medications were not reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: been in bed since Friday night; no energy; headache; still has some Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (been in bed since Friday night), ASTHENIA (no energy), FATIGUE (still has some Fatigue) and HEADACHE (headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included Asymptomatic COVID-19 on 31-Oct-2020.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced FATIGUE (still has some Fatigue). On 27-Aug-2021, the patient experienced BEDRIDDEN (been in bed since Friday night), ASTHENIA (no energy) and HEADACHE (headache). At the time of the report, BEDRIDDEN (been in bed since Friday night) and ASTHENIA (no energy) was resolving and FATIGUE (still has some Fatigue) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2020, SARS-CoV-2 test: positive (Positive) asymptomatic COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Medical history, Lab data, vaccination information, event  headache outcome was updated as  to not recovered and new event fatigue.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received the vaccine with 15 years of age; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the vaccine with 15 years of age) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), MONTELUKAST SODIUM (SINGULAIR) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Asthma, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.    On 31-Jul-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 (Received the vaccine with 15 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the vaccine with 15 years of age) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     They went to another facility to get the second dose they refused to give it to him due to his age.
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) 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 SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided. Patient was put on an antibiotic for sinus infection.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (patient received expired Moderna COVID-19 vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 007C21A) for COVID-19 immunization. No medical history reported. On Aug 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 27, 2021, patient experienced administered expired product (patient received expired Moderna COVID-19 vaccine). On Aug 27, 2021, administered expired product (patient received expired Moderna COVID-19 vaccine): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vaccine was placed in the refrigerator from the freezer on Jul 12, 2021. There were a total of 5 ten dose vials expired past the beyond-use-date of Aug 11, 2021 in the refrigerator.
Sex: U
Vaccine: COVID19
Symptoms: Candida infection
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of candida infection (candida overgrowth) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced candida infection (candida overgrowth). At the time of the report, candida infection (candida overgrowth) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Enlarged lymph nodes) 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 LYMPHADENOPATHY (Enlarged lymph nodes). At the time of the report, LYMPHADENOPATHY (Enlarged lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Still running a fever today, it's not that high) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included METHOTREXATE for an unknown indication. On 27-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced PYREXIA (Still running a fever today, it's not that high). At the time of the report, PYREXIA (Still running a fever today, it's not that high) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: high (High) high (104.4 degree F temp.). No treatment history was reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Got the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant) in a 40-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 28-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 2 dosage form. The patient's last menstrual period was on 12-Jan-2021 and the estimated date of delivery was date. On 26-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown; Sender's Comments: This is a case of product exposure during pregnancy (maternal exposure during pregnancy) with no associated AEs for this 40-year-old female. Reportedly, the second of the vaccine was administered during pregnancy. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. The company causality for the event of maternal exposure during pregnancy is not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue (felt very tired since the shot) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 31, 2021, patient experienced fatigue (felt very tired since the shot). At the time of the report, fatigue (felt very tired since the shot) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypokinesia, Influenza like illness, Migraine
Clinical narrative: deathly migraine; vomiting; nauseas, I throw up 1 time a day; fatigue; body ache, body hurt; started feeling bad; flu like; Shaky; could not move arms or head; all possible side effects that everyone told; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling bad), INFLUENZA LIKE ILLNESS (flu like), NERVOUSNESS (Shaky), HYPOKINESIA (could not move arms or head) and VACCINATION COMPLICATION (all possible side effects that everyone told) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced FEELING ABNORMAL (started feeling bad), INFLUENZA LIKE ILLNESS (flu like), NERVOUSNESS (Shaky), HYPOKINESIA (could not move arms or head), VACCINATION COMPLICATION (all possible side effects that everyone told) and MYALGIA (body ache, body hurt). On 20-May-2021, the patient experienced MIGRAINE (deathly migraine), VOMITING (vomiting), NAUSEA (nauseas, I throw up 1 time a day) and FATIGUE (fatigue). The patient was treated with ONDANSETRON for Nausea, at an unspecified dose and frequency; BUTALBITAL, PARACETAMOL (BUTALBITAL AND ACETAMINOPHEN) for Migraine, at an unspecified dose and frequency and GABAPENTIN for Migraine, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (started feeling bad), INFLUENZA LIKE ILLNESS (flu like), NERVOUSNESS (Shaky), HYPOKINESIA (could not move arms or head), VACCINATION COMPLICATION (all possible side effects that everyone told), MIGRAINE (deathly migraine), MYALGIA (body ache, body hurt), VOMITING (vomiting), NAUSEA (nauseas, I throw up 1 time a day) and FATIGUE (fatigue) outcome was unknown.            Patient reported every Blood test, Urine test and every test under the sun found nothing. Rheumatologist did not found anything and neurologist did MRI but found nothing and gave prescription for migraine. Concomitant medication was not provided
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Nervousness, Vaccination complication, Vomiting
Clinical narrative: deathly migraine; vomiting; nauseas, I throw up 1 time a day; fatigue; body ache, body hurt; started feeling bad; flu like; Shaky; could not move arms or head; all possible side effects that everyone told; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (started feeling bad), INFLUENZA LIKE ILLNESS (flu like), NERVOUSNESS (Shaky), HYPOKINESIA (could not move arms or head) and VACCINATION COMPLICATION (all possible side effects that everyone told) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced FEELING ABNORMAL (started feeling bad), INFLUENZA LIKE ILLNESS (flu like), NERVOUSNESS (Shaky), HYPOKINESIA (could not move arms or head), VACCINATION COMPLICATION (all possible side effects that everyone told) and MYALGIA (body ache, body hurt). On 20-May-2021, the patient experienced MIGRAINE (deathly migraine), VOMITING (vomiting), NAUSEA (nauseas, I throw up 1 time a day) and FATIGUE (fatigue). The patient was treated with ONDANSETRON for Nausea, at an unspecified dose and frequency; BUTALBITAL, PARACETAMOL (BUTALBITAL AND ACETAMINOPHEN) for Migraine, at an unspecified dose and frequency and GABAPENTIN for Migraine, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (started feeling bad), INFLUENZA LIKE ILLNESS (flu like), NERVOUSNESS (Shaky), HYPOKINESIA (could not move arms or head), VACCINATION COMPLICATION (all possible side effects that everyone told), MIGRAINE (deathly migraine), MYALGIA (body ache, body hurt), VOMITING (vomiting), NAUSEA (nauseas, I throw up 1 time a day) and FATIGUE (fatigue) outcome was unknown.            Patient reported every Blood test, Urine test and every test under the sun found nothing. Rheumatologist did not found anything and neurologist did MRI but found nothing and gave prescription for migraine. Concomitant medication was not provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient had second vaccine and having side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient had second vaccine and having side effects ) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient had second vaccine and having side effects ). At the time of the report, VACCINATION COMPLICATION (Patient had second vaccine and having side effects ) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.