chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu-like symptoms (1st dose); body aches (1st dose); Fever (1st dose); Bad headache (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms (1st dose)), MYALGIA (body aches (1st dose)), PYREXIA (Fever (1st dose)) and HEADACHE (Bad headache (1st dose)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms (1st dose)), MYALGIA (body aches (1st dose)), PYREXIA (Fever (1st dose)) and HEADACHE (Bad headache (1st dose)). On 16-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms (1st dose)), MYALGIA (body aches (1st dose)), PYREXIA (Fever (1st dose)) and HEADACHE (Bad headache (1st dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-307462 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching
Clinical narrative: left foot is numb/left leg is getting numb; left leg is twitching; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left foot is numb/left leg is getting numb) and MUSCLE TWITCHING (left leg is twitching) 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 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 03-Sep-2021, the patient experienced HYPOAESTHESIA (left foot is numb/left leg is getting numb) and MUSCLE TWITCHING (left leg is twitching). At the time of the report, HYPOAESTHESIA (left foot is numb/left leg is getting numb) and MUSCLE TWITCHING (left leg is twitching) outcome was unknown.            Concomitant medication was not reported.  Treatment information was not provided.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain/chest pain started 6 hours after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain/chest pain started 6 hours after vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     Concomitant products included TRAZODONE, LAMOTRIGINE and CITALOPRAM for an unknown indication.    On 01-Sep-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 CHEST PAIN (Chest pain/chest pain started 6 hours after vaccine). At the time of the report, CHEST PAIN (Chest pain/chest pain started 6 hours after vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) 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 16-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     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 details were not reported by the reporter. Treatment details were not reported by the reporter. Patient reported that he did not took any treatment and had tested negative.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Illness
Clinical narrative: Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome; Weakness; Diarrhea; Site of the shot is crazy; Got really sick; Vomiting; High fever; Achy body; Bad headaches; Chills; Red; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), VACCINATION SITE REACTION (Site of the shot is crazy) and ILLNESS (Got really sick) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 02B21A and 013AZ(2)1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (Last year) in 2020. Concurrent medical conditions included Diabetes mellitus insulin-dependent, Thyroid disorder NOS and Blood pressure high. Concomitant products included BENAZEPRIL for Blood pressure high, INSULIN LISPRO (HUMALOG) for Diabetes mellitus insulin-dependent, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Open heart surgery, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, BRINZOLAMIDE (AZOPT) and DULOXETINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced PHOTOPHOBIA (Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), VACCINATION SITE REACTION (Site of the shot is crazy), ILLNESS (Got really sick), VOMITING (Vomiting), PYREXIA (High fever), MYALGIA (Achy body), HEADACHE (Bad headaches), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, PHOTOPHOBIA (Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), VACCINATION SITE REACTION (Site of the shot is crazy), ILLNESS (Got really sick), VOMITING (Vomiting), PYREXIA (High fever), MYALGIA (Achy body), HEADACHE (Bad headaches), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.            It was reported that the patient was in high risk category.  Treatment information was not provided.     This case was linked to MOD-2021-307192 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Photophobia, Pyrexia, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome; Weakness; Diarrhea; Site of the shot is crazy; Got really sick; Vomiting; High fever; Achy body; Bad headaches; Chills; Red; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), VACCINATION SITE REACTION (Site of the shot is crazy) and ILLNESS (Got really sick) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 02B21A and 013AZ(2)1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (Last year) in 2020. Concurrent medical conditions included Diabetes mellitus insulin-dependent, Thyroid disorder NOS and Blood pressure high. Concomitant products included BENAZEPRIL for Blood pressure high, INSULIN LISPRO (HUMALOG) for Diabetes mellitus insulin-dependent, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Open heart surgery, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, BRINZOLAMIDE (AZOPT) and DULOXETINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced PHOTOPHOBIA (Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), VACCINATION SITE REACTION (Site of the shot is crazy), ILLNESS (Got really sick), VOMITING (Vomiting), PYREXIA (High fever), MYALGIA (Achy body), HEADACHE (Bad headaches), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, PHOTOPHOBIA (Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), VACCINATION SITE REACTION (Site of the shot is crazy), ILLNESS (Got really sick), VOMITING (Vomiting), PYREXIA (High fever), MYALGIA (Achy body), HEADACHE (Bad headaches), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.            It was reported that the patient was in high risk category.  Treatment information was not provided.     This case was linked to MOD-2021-307192 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome; Weakness; Diarrhea; Site of the shot is crazy; Got really sick; Vomiting; High fever; Achy body; Bad headaches; Chills; Red; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), VACCINATION SITE REACTION (Site of the shot is crazy) and ILLNESS (Got really sick) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 02B21A and 013AZ(2)1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (Last year) in 2020. Concurrent medical conditions included Diabetes mellitus insulin-dependent, Thyroid disorder NOS and Blood pressure high. Concomitant products included BENAZEPRIL for Blood pressure high, INSULIN LISPRO (HUMALOG) for Diabetes mellitus insulin-dependent, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Open heart surgery, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, BRINZOLAMIDE (AZOPT) and DULOXETINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced PHOTOPHOBIA (Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), VACCINATION SITE REACTION (Site of the shot is crazy), ILLNESS (Got really sick), VOMITING (Vomiting), PYREXIA (High fever), MYALGIA (Achy body), HEADACHE (Bad headaches), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, PHOTOPHOBIA (Something with the eye/Is fine now but not perfect/Sensitivity to light was bothersome), ASTHENIA (Weakness), DIARRHOEA (Diarrhea), VACCINATION SITE REACTION (Site of the shot is crazy), ILLNESS (Got really sick), VOMITING (Vomiting), PYREXIA (High fever), MYALGIA (Achy body), HEADACHE (Bad headaches), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.            It was reported that the patient was in high risk category.  Treatment information was not provided.     This case was linked to MOD-2021-307192 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: more than 35 days since got the first dose and still does not have the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 35 days since got the first dose and still does not have the second) 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 23-Jun-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 DOSE OMISSION ISSUE (more than 35 days since got the first dose and still does not have the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 35 days since got the first dose and still does not have the second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reportedly, the dose 2 was scheduled on 21-JUL-2021, and she had missed her appointment.  Concomitant product use was not provided.  Treatment product information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: a lot of side effects; still not feeling good; headache; fatigue; vomiting; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a lot of side effects), MALAISE (still not feeling good), HEADACHE (headache), FATIGUE (fatigue) and VOMITING (vomiting) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02or3Tor5EorC21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (a lot of side effects), MALAISE (still not feeling good), HEADACHE (headache), FATIGUE (fatigue), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (a lot of side effects), MALAISE (still not feeling good), HEADACHE (headache), FATIGUE (fatigue), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body ache) outcome was unknown.            No concomitant medications were not reported. Patient wants to know if she can take ibuprofen. She also mentioned that she's going to start IVF to get pregnant, and she wants to know if there's awaiting period from the last vaccine to her IVF treatment. The IVF doctor recommended her get the vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vomiting
Clinical narrative: a lot of side effects; still not feeling good; headache; fatigue; vomiting; chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a lot of side effects), MALAISE (still not feeling good), HEADACHE (headache), FATIGUE (fatigue) and VOMITING (vomiting) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02or3Tor5EorC21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (a lot of side effects), MALAISE (still not feeling good), HEADACHE (headache), FATIGUE (fatigue), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (a lot of side effects), MALAISE (still not feeling good), HEADACHE (headache), FATIGUE (fatigue), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body ache) outcome was unknown.            No concomitant medications were not reported. Patient wants to know if she can take ibuprofen. She also mentioned that she's going to start IVF to get pregnant, and she wants to know if there's awaiting period from the last vaccine to her IVF treatment. The IVF doctor recommended her get the vaccine.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tendon rupture
Clinical narrative: Inappropriate schedule of vaccine administered; She started experiencing torn Achilles tendon beginning of April; This spontaneous case was reported by a consumer and describes the occurrence of TENDON RUPTURE (She started experiencing torn Achilles tendon beginning of April) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 90-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 LEVOTHYROXINE, GABAPENTIN and VITAMINS NOS for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced TENDON RUPTURE (She started experiencing torn Achilles tendon beginning of April). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, TENDON RUPTURE (She started experiencing torn Achilles tendon beginning of April) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: whose disease have flared; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (whose disease have flared) 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 CONDITION AGGRAVATED (whose disease have flared). At the time of the report, CONDITION AGGRAVATED (whose disease have flared) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Somnolence
Clinical narrative: I started getting itchy, in hands, feet, it was so strange; sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy) and PRURITUS (I started getting itchy, in hands, feet, it was so strange) 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 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced SOMNOLENCE (sleepy). On 24-Aug-2021, the patient experienced PRURITUS (I started getting itchy, in hands, feet, it was so strange). On 18-Aug-2021, SOMNOLENCE (sleepy) had resolved. At the time of the report, PRURITUS (I started getting itchy, in hands, feet, it was so strange) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Illness, Mouth ulceration
Clinical narrative: Chills; Injection site was pretty big; (Injection site) hurt really bad; Made her very sick; Feel really bad/ it was like having covid all over again; Had body aches; Had 100.1 F/  Fever; Ulcers inside my mouth; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Made her very sick), FEELING ABNORMAL (Feel really bad/ it was like having covid all over again), MOUTH ULCERATION (Ulcers inside my mouth), MYALGIA (Had body aches) and PYREXIA (Had 100.1 F/  Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2021.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced ILLNESS (Made her very sick), FEELING ABNORMAL (Feel really bad/ it was like having covid all over again), MYALGIA (Had body aches) and PYREXIA (Had 100.1 F/  Fever). On an unknown date, the patient experienced MOUTH ULCERATION (Ulcers inside my mouth), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site was pretty big), VACCINATION SITE PAIN ((Injection site) hurt really bad) and FATIGUE (Very tired). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ILLNESS (Made her very sick), FEELING ABNORMAL (Feel really bad/ it was like having covid all over again), MOUTH ULCERATION (Ulcers inside my mouth), MYALGIA (Had body aches), PYREXIA (Had 100.1 F/  Fever), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site was pretty big), VACCINATION SITE PAIN ((Injection site) hurt really bad) and FATIGUE (Very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. Patient stated that Second shot scheduled for 04Sep2021.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Chills; Injection site was pretty big; (Injection site) hurt really bad; Made her very sick; Feel really bad/ it was like having covid all over again; Had body aches; Had 100.1 F/  Fever; Ulcers inside my mouth; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Made her very sick), FEELING ABNORMAL (Feel really bad/ it was like having covid all over again), MOUTH ULCERATION (Ulcers inside my mouth), MYALGIA (Had body aches) and PYREXIA (Had 100.1 F/  Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2021.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Aug-2021, the patient experienced ILLNESS (Made her very sick), FEELING ABNORMAL (Feel really bad/ it was like having covid all over again), MYALGIA (Had body aches) and PYREXIA (Had 100.1 F/  Fever). On an unknown date, the patient experienced MOUTH ULCERATION (Ulcers inside my mouth), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site was pretty big), VACCINATION SITE PAIN ((Injection site) hurt really bad) and FATIGUE (Very tired). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ILLNESS (Made her very sick), FEELING ABNORMAL (Feel really bad/ it was like having covid all over again), MOUTH ULCERATION (Ulcers inside my mouth), MYALGIA (Had body aches), PYREXIA (Had 100.1 F/  Fever), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site was pretty big), VACCINATION SITE PAIN ((Injection site) hurt really bad) and FATIGUE (Very tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. Patient stated that Second shot scheduled for 04Sep2021.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Elder females do get diarrhea with the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (Elder females do get diarrhea with the Moderna vaccine   ) 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 DIARRHOEA (Elder females do get diarrhea with the Moderna vaccine   ). At the time of the report, DIARRHOEA (Elder females do get diarrhea with the Moderna vaccine   ) 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 and Treatment was not specified.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Vaccination site pain
Clinical narrative: Brain fog; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and CONFUSIONAL STATE (Brain fog) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 01-Sep-2021, the patient experienced CONFUSIONAL STATE (Brain fog). At the time of the report, VACCINATION SITE PAIN (Sore arm) and CONFUSIONAL STATE (Brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chest pain
Clinical narrative: I had like a heart pain/I felt pain in my left side; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I had like a heart pain/I felt pain in my left side) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (I had like a heart pain/I felt pain in my left side). At the time of the report, CHEST PAIN (I had like a heart pain/I felt pain in my left side) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test (700-1600 mg/dl): 192 mg/dl Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-307662 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itch on her feet and hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch on her feet and hands) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 013L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itch on her feet and hands). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of used it as a cream; CORTISONE for Itch, at an unspecified dose and frequency and CAMPHOR, MENTHOL (SARNA [CAMPHOR;MENTHOL]) for Itch, at an unspecified dose and frequency. At the time of the report, PRURITUS (itch on her feet and hands) had not resolved.            Concomitant medications were not reported.   The patient had a delayed reaction, 8 days after receiving of 3rd dose. She then said the delayed reaction started 25-Aug-2021.  The patient was still experiencing the reaction and it was reported as "just consistently bad."  She looked online and it was mentioned as delayed reactions. She went to a doctor but had not gone for this reaction yet.  The patient stated that she had tried everything,and it felt like it was in her nervous system.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: The patient did not recieve 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The patient did not recieve 2nd dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient did not recieve 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient did not recieve 2nd dose) had resolved.        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.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: Injection site is very sore; Been in bed since 2 last night/feeling very not well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Been in bed since 2 last night/feeling very not well) and VACCINATION SITE PAIN (Injection site is very sore) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced VACCINATION COMPLICATION (Been in bed since 2 last night/feeling very not well). On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site is very sore). At the time of the report, VACCINATION COMPLICATION (Been in bed since 2 last night/feeling very not well) and VACCINATION SITE PAIN (Injection site is very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (upper respiratory 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection). The patient was treated with CODEINE (oral) on 19-Aug-2021 for Cough, at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and AZITHROMYCIN (Z-PAK) for Product used for unknown indication, at an unspecified dose and frequency. At the time of the report, UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information also included Z-pack for upper respiratory tract infection started on 21-august-2021, last dose was on 27-august-2021.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with expired vaccines; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021.     Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccines). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccines) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported.  No treatment medications were reported.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Pyrexia, Vomiting
Clinical narrative: Very Dizzy; temp. was 100.8°; Tried to vomit but there was nothing in my stomach; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Very Dizzy), PYREXIA (temp. was 100.8°) and VOMITING (Tried to vomit but there was nothing in my stomach) in a 73-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 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 DIZZINESS (Very Dizzy), PYREXIA (temp. was 100.8°) and VOMITING (Tried to vomit but there was nothing in my stomach). At the time of the report, DIZZINESS (Very Dizzy), PYREXIA (temp. was 100.8°) and VOMITING (Tried to vomit but there was nothing in my stomach) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 (High) 100.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Throat irritation
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness (lightheaded for 1 week), throat irritation (throat scratchy for 2 days) and pain in extremity (her arm hurt half a day) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 040C21A) for COVID-19 immunization. No medical history reported. On Aug 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 6, 2021, patient experienced dizziness (lightheaded for 1 week), throat irritation (throat scratchy for 2 days) and pain in extremity (her arm hurt half a day). On Aug 6, 2021, pain in extremity (her arm hurt half a day) resolved. On Aug 8, 2021, throat irritation (throat scratchy for 2 days) resolved. On Aug 13, 2021, dizziness (lightheaded for 1 week) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. This case  linked to MOD-2021-307941 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report vaccine side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report vaccine side effects) 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 VACCINATION COMPLICATION (Report vaccine side effects). At the time of the report, VACCINATION COMPLICATION (Report vaccine side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: She is having allergic reaction to booster; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (She is having allergic reaction to booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (She is having allergic reaction to booster). At the time of the report, ALLERGY TO VACCINE (She is having allergic reaction to booster) outcome was unknown.            No Concomitant medication was reported.  No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: particular reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (particular reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (autoimmune disorders).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (particular reaction). At the time of the report, VACCINATION COMPLICATION (particular reaction) outcome was unknown.            No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: BEING EXPOSED TO SOMEONE WHO MIGHT HAVE BEEN REINFECTED WITH VIRUS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-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 EXPOSURE TO SARS-COV-2 (BEING EXPOSED TO SOMEONE WHO MIGHT HAVE BEEN REINFECTED WITH VIRUS) 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 April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (BEING EXPOSED TO SOMEONE WHO MIGHT HAVE BEEN REINFECTED WITH VIRUS). At the time of the report, EXPOSURE TO SARS-COV-2 (BEING EXPOSED TO SOMEONE WHO MIGHT HAVE BEEN REINFECTED WITH VIRUS) outcome was unknown.            No concomitant medications were provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: little more soreness; 2 days of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (little more soreness) and FATIGUE (2 days of fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063E21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation and Cholesterol.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (little more soreness) and FATIGUE (2 days of fatigue). At the time of the report, MYALGIA (little more soreness) and FATIGUE (2 days of fatigue) had resolved.            Concomitant medications included A-fib Medication and Cholesterol Medication. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Is my arm supposed to be hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Is my arm supposed to be hurting) 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 VACCINATION SITE PAIN (Is my arm supposed to be hurting). At the time of the report, VACCINATION SITE PAIN (Is my arm supposed to be hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided. No Concomitant medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Adverse event following immunisation, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID test after vaccination; Two doses did not stop me from contracting COVID; Bad reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID test after vaccination), ADVERSE EVENT FOLLOWING IMMUNISATION (Bad reaction to the vaccine) and DRUG INEFFECTIVE (Two doses did not stop me from contracting COVID) 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 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (Bad reaction to the vaccine). On 01-Sep-2021, the patient experienced COVID-19 (Positive COVID test after vaccination) and DRUG INEFFECTIVE (Two doses did not stop me from contracting COVID). At the time of the report, COVID-19 (Positive COVID test after vaccination), ADVERSE EVENT FOLLOWING IMMUNISATION (Bad reaction to the vaccine) and DRUG INEFFECTIVE (Two doses did not stop me from contracting COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant drug details were reported. No treatment details were reported.; Sender's Comments: This case has a limited information. Case is not valid until patient is provided. This is a case of lack of efficacy of the vaccine, therefore causal association between the event is assessed as possible. Based on the mechanism of action of mRNA-1273 ,causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. However, 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: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received both doses at 16 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received both doses at 16 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Autoimmune disorder.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received both doses at 16 years old). In 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received both doses at 16 years old) had resolved.            Concomitant medications were not provided by reporter.  Treatment information was not provided by reporter.   This case was linked to MOD-2021-308656, MOD-2021-299882, MOD-2021-299844, MOD-2021-308669 (Patient Link).