chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Thinks she has start of a sinus infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Thinks she has start of a sinus infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SINUSITIS (Thinks she has start of a sinus infection). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, SINUSITIS (Thinks she has start of a sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: fever; terrible aching; headache; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (terrible aching), HEADACHE (headache) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), MYALGIA (terrible aching), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), MYALGIA (terrible aching), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lip swelling, Pyrexia, Rash, Rash pruritic
Clinical narrative: fever; chills; vomiting; Rash is itchy; developed rash all over body, started on thighs and then lip was swelling; developed rash all over body, started on thighs and then lip was swelling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), CHILLS (chills), VOMITING (vomiting), RASH (developed rash all over body, started on thighs and then lip was swelling) and LIP SWELLING (developed rash all over body, started on thighs and then lip was swelling) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VITAMINS NOS.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced RASH (developed rash all over body, started on thighs and then lip was swelling) and LIP SWELLING (developed rash all over body, started on thighs and then lip was swelling). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), VOMITING (vomiting) and RASH PRURITIC (Rash is itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chills), VOMITING (vomiting), RASH (developed rash all over body, started on thighs and then lip was swelling), LIP SWELLING (developed rash all over body, started on thighs and then lip was swelling) and RASH PRURITIC (Rash is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: fever; chills; vomiting; Rash is itchy; developed rash all over body, started on thighs and then lip was swelling; developed rash all over body, started on thighs and then lip was swelling; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 25-Feb-2021.    This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), CHILLS (chills), VOMITING (vomiting), RASH (developed rash all over body, started on thighs and then lip was swelling) and LIP SWELLING (developed rash all over body, started on thighs and then lip was swelling) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VITAMINS NOS.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced RASH (developed rash all over body, started on thighs and then lip was swelling) and LIP SWELLING (developed rash all over body, started on thighs and then lip was swelling). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), VOMITING (vomiting) and RASH PRURITIC (Rash is itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chills), VOMITING (vomiting), RASH (developed rash all over body, started on thighs and then lip was swelling), LIP SWELLING (developed rash all over body, started on thighs and then lip was swelling) and RASH PRURITIC (Rash is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive SARS-CoV-2; 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 SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive SARS-CoV-2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test positive: 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.   No concomitant and treatment medications were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: arm soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm soreness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event and No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PAIN (arm soreness). At the time of the report, INJECTION SITE PAIN (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant information was not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever 101.0 and 100.0; Very bad headache; A spontaneous report was received from a consumer concerning who received Modern's COVID-19 vaccine (mRNA-1273) patient who developed very bad headache and fever of 101 ,100.0.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) ON 22-FEB-2021, same day prior to the onset of the events intramuscularly for prophylaxis of COVID-19 infection.  Treatment information was not provided.   Therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events were unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: patient's arm  has been a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (patient's arm  has been a little sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Hodgkin's disease ((Hodgkins Lymphoma)).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (patient's arm  has been a little sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (patient's arm  has been a little sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and NAUSEA (Nausea) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever) and CHILLS (chills) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). At the time of the report, PYREXIA (Fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Concomitant and treatment information not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site pain, Vomiting
Clinical narrative: headache; chills; vomiting; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (injection arm soreness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (headache), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (injection arm soreness). At the time of the report, HEADACHE (headache), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (injection arm soreness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscular weakness, Vaccination site pain
Clinical narrative: weakness in legs; pain at injection; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in legs), VACCINATION SITE PAIN (pain at injection) and FATIGUE (fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs), VACCINATION SITE PAIN (pain at injection) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK. On 29-Jan-2021, MUSCULAR WEAKNESS (weakness in legs), VACCINATION SITE PAIN (pain at injection) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Papule, Pruritus
Clinical narrative: Itchy red bumps on her torso (front and back); bumps on her torso (front and back); red bumps on her torso (front and back); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy red bumps on her torso (front and back)), PAPULE (bumps on her torso (front and back)) and ERYTHEMA (red bumps on her torso (front and back)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRURITUS (Itchy red bumps on her torso (front and back)), PAPULE (bumps on her torso (front and back)) and ERYTHEMA (red bumps on her torso (front and back)). At the time of the report, PRURITUS (Itchy red bumps on her torso (front and back)), PAPULE (bumps on her torso (front and back)) and ERYTHEMA (red bumps on her torso (front and back)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: firmness at the site of injection; itching at injection site; redness/pinkness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (firmness at the site of injection), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (redness/pinkness at the site of injection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031420A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, GLIPIZIDE, METOPROLOL, LISINOPRIL and WARFARIN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (redness/pinkness at the site of injection). On 24-Feb-2021, the patient experienced VACCINATION SITE INDURATION (firmness at the site of injection) and VACCINATION SITE PRURITUS (itching at injection site). At the time of the report, VACCINATION SITE INDURATION (firmness at the site of injection), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (redness/pinkness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Stress, Urticaria cholinergic
Clinical narrative: stressed out and have hives; stressed out and have hives; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (stressed out and have hives) and URTICARIA CHOLINERGIC (stressed out and have hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hives.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced URTICARIA CHOLINERGIC (stressed out and have hives). On an unknown date, the patient experienced STRESS (stressed out and have hives). At the time of the report, STRESS (stressed out and have hives) and URTICARIA CHOLINERGIC (stressed out and have hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: diarrhea lasted several days; fatigue; headaches; nausea lasted several days; terrible congestion, upper respiratory related; lost of appetite; lost of taste; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT CONGESTION (terrible congestion, upper respiratory related), DECREASED APPETITE (lost of appetite), AGEUSIA (lost of taste), DIARRHOEA (diarrhea lasted several days) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced UPPER RESPIRATORY TRACT CONGESTION (terrible congestion, upper respiratory related), DECREASED APPETITE (lost of appetite), DIARRHOEA (diarrhea lasted several days), FATIGUE (fatigue), HEADACHE (headaches) and NAUSEA (nausea lasted several days). In January 2021, the patient experienced AGEUSIA (lost of taste). At the time of the report, UPPER RESPIRATORY TRACT CONGESTION (terrible congestion, upper respiratory related), DECREASED APPETITE (lost of appetite), AGEUSIA (lost of taste), DIARRHOEA (diarrhea lasted several days), FATIGUE (fatigue), HEADACHE (headaches) and NAUSEA (nausea lasted several days) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative twice.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Upper respiratory tract congestion
Clinical narrative: diarrhea lasted several days; fatigue; headaches; nausea lasted several days; terrible congestion, upper respiratory related; lost of appetite; lost of taste; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT CONGESTION (terrible congestion, upper respiratory related), DECREASED APPETITE (lost of appetite), AGEUSIA (lost of taste), DIARRHOEA (diarrhea lasted several days) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced UPPER RESPIRATORY TRACT CONGESTION (terrible congestion, upper respiratory related), DECREASED APPETITE (lost of appetite), DIARRHOEA (diarrhea lasted several days), FATIGUE (fatigue), HEADACHE (headaches) and NAUSEA (nausea lasted several days). In January 2021, the patient experienced AGEUSIA (lost of taste). At the time of the report, UPPER RESPIRATORY TRACT CONGESTION (terrible congestion, upper respiratory related), DECREASED APPETITE (lost of appetite), AGEUSIA (lost of taste), DIARRHOEA (diarrhea lasted several days), FATIGUE (fatigue), HEADACHE (headaches) and NAUSEA (nausea lasted several days) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative twice.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Feeling abnormal, Nausea, Vomiting
Clinical narrative: cant keep down fluids, and diarrhea; Nausea; Vomiting; Abdominal Cramps; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal Cramps), FEELING ABNORMAL (Felt terrible), DIARRHOEA (cant keep down fluids, and diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced ABDOMINAL PAIN (Abdominal Cramps), FEELING ABNORMAL (Felt terrible), NAUSEA (Nausea) and VOMITING (Vomiting). On 04-Feb-2021, the patient experienced DIARRHOEA (cant keep down fluids, and diarrhea). At the time of the report, ABDOMINAL PAIN (Abdominal Cramps), FEELING ABNORMAL (Felt terrible), DIARRHOEA (cant keep down fluids, and diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient took no treatment.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: Arm pain; fatigue; Fever (100.4F); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm pain), FATIGUE (fatigue) and PYREXIA (Fever (100.4F)) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE PAIN (Arm pain), FATIGUE (fatigue) and PYREXIA (Fever (100.4F)). On 16-Feb-2021, INJECTION SITE PAIN (Arm pain), FATIGUE (fatigue) and PYREXIA (Fever (100.4F)) had resolved. Not Provided          No concomitant medications reported by investigator o No treatment medications provided by the reporter.   This case was linked to MOD-2021-024269 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pain, Pain in extremity
Clinical narrative: dizziness; Body ache; Nausea; Chills; Sore arm; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body aches), DIZZINESS (dizziness), PAIN (Body ache) and NAUSEA (Nausea) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), HCTZ, LISINOPRIL, SERTRALINE, SIMVASTATIN, BIMATOPROST (LUMIGAN) and DORZOLAMIDE for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PAIN (Body aches). On 23-Feb-2021, the patient experienced DIZZINESS (dizziness), PAIN (Body ache), NAUSEA (Nausea) and CHILLS (Chills). On 10-Feb-2021, PAIN (Body aches) had resolved. On 11-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, DIZZINESS (dizziness), PAIN (Body ache), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Treatment information was not provided.   This case was linked to MOD-2021-024355 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flatulence, Injection site pain, Rash erythematous, Vaccination complication
Clinical narrative: looks like an allergic reaction; still does not feel real good; her cheeks gets red; Stomach has a bunch of growling and gassy like; 3 to 4 hours of vomiting; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and INJECTION SITE PAIN (very sore arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and METOPROLOL for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PAIN (very sore arm). On 29-Jan-2021, the patient experienced VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and VOMITING (3 to 4 hours of vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, VOMITING (3 to 4 hours of vomiting) had resolved. At the time of the report, VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and INJECTION SITE PAIN (very sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol and Ibuprofen used as a Treatment medication
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: looks like an allergic reaction; still does not feel real good; her cheeks gets red; Stomach has a bunch of growling and gassy like; 3 to 4 hours of vomiting; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and INJECTION SITE PAIN (very sore arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and METOPROLOL for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PAIN (very sore arm). On 29-Jan-2021, the patient experienced VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and VOMITING (3 to 4 hours of vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, VOMITING (3 to 4 hours of vomiting) had resolved. At the time of the report, VACCINATION COMPLICATION (looks like an allergic reaction), FEELING ABNORMAL (still does not feel real good), RASH ERYTHEMATOUS (her cheeks gets red), FLATULENCE (Stomach has a bunch of growling and gassy like) and INJECTION SITE PAIN (very sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol and Ibuprofen used as a Treatment medication
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Menstruation irregular, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Sore throat; Swollen tonsils; Multiple cycles each month; cold like symptoms; minor headach/Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), TONSILLAR HYPERTROPHY (Swollen tonsils), MENSTRUATION IRREGULAR (Multiple cycles each month), NASOPHARYNGITIS (cold like symptoms) and HEADACHE (minor headach/Headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine in 2004. Concurrent medical conditions included Anxiety since 2012. Concomitant products included SERTRALINE for Anxiety.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (minor headach/Headache) and FATIGUE (Fatigue). On 02-Feb-2021, the patient experienced NASOPHARYNGITIS (cold like symptoms). On 03-Feb-2021, the patient experienced MENSTRUATION IRREGULAR (Multiple cycles each month). On 23-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and TONSILLAR HYPERTROPHY (Swollen tonsils). On 30-Jan-2021, HEADACHE (minor headach/Headache) and FATIGUE (Fatigue) had resolved. On 27-Feb-2021, NASOPHARYNGITIS (cold like symptoms) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and TONSILLAR HYPERTROPHY (Swollen tonsils) outcome was unknown and MENSTRUATION IRREGULAR (Multiple cycles each month) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported.  The patient not had any actute illness at the time of vaccination and up to 1 month before.The patient had not experienced similar adverse event in the past and not had other potential causes for the event.Beginning in February 2021, The patient began to had her period twice a month. She had that each month to date (August 2021). In April, she had her intrauterine device (IUD) checked to make sure that had not become misplaced. The ultra sound showed that her IUD was still in place.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional information received: Suspect product information and reporter contact details updated. On 03-Aug-2021: Follow-up received: Patient details, relevant medical history added, Dosing regimen added, concomitant medication information added,  new events added as a fatigue, Irregular menstrual cycle and cold and narrative updated.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tonsillar hypertrophy
Clinical narrative: Sore throat; Swollen tonsils; Multiple cycles each month; cold like symptoms; minor headach/Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), TONSILLAR HYPERTROPHY (Swollen tonsils), MENSTRUATION IRREGULAR (Multiple cycles each month), NASOPHARYNGITIS (cold like symptoms) and HEADACHE (minor headach/Headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine in 2004. Concurrent medical conditions included Anxiety since 2012. Concomitant products included SERTRALINE for Anxiety.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (minor headach/Headache) and FATIGUE (Fatigue). On 02-Feb-2021, the patient experienced NASOPHARYNGITIS (cold like symptoms). On 03-Feb-2021, the patient experienced MENSTRUATION IRREGULAR (Multiple cycles each month). On 23-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and TONSILLAR HYPERTROPHY (Swollen tonsils). On 30-Jan-2021, HEADACHE (minor headach/Headache) and FATIGUE (Fatigue) had resolved. On 27-Feb-2021, NASOPHARYNGITIS (cold like symptoms) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and TONSILLAR HYPERTROPHY (Swollen tonsils) outcome was unknown and MENSTRUATION IRREGULAR (Multiple cycles each month) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported.  The patient not had any actute illness at the time of vaccination and up to 1 month before.The patient had not experienced similar adverse event in the past and not had other potential causes for the event.Beginning in February 2021, The patient began to had her period twice a month. She had that each month to date (August 2021). In April, she had her intrauterine device (IUD) checked to make sure that had not become misplaced. The ultra sound showed that her IUD was still in place.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional information received: Suspect product information and reporter contact details updated. On 03-Aug-2021: Follow-up received: Patient details, relevant medical history added, Dosing regimen added, concomitant medication information added,  new events added as a fatigue, Irregular menstrual cycle and cold and narrative updated.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: large red area on the arm; area was bumpy like a rash; A spontaneous report was received from a Consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events large red area on the arm(erythema), area was bumpy like a rash(rash).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021,approximately 4 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038K20A) intramuscularly in arm for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the event(s) large red area on the arm and area was bumpy like a rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s) large red area on the arm and area was bumpy like a rash was considered resolved on 15 Feb 2021. .
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain
Clinical narrative: PAIN AT THE INJECTION SITE; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (PAIN AT THE INJECTION SITE) and CHILLS (CHILLS) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNKNOWN and UNKNOWN) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INJECTION SITE PAIN (PAIN AT THE INJECTION SITE) and CHILLS (CHILLS). At the time of the report, INJECTION SITE PAIN (PAIN AT THE INJECTION SITE) and CHILLS (CHILLS) had not resolved. Not Provided          No concomitant medications reported by investigator TYLENOL AND ORANGE JUICE used as Treatment medication.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: shoulder was sore; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder was sore) 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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (shoulder was sore). At the time of the report, ARTHRALGIA (shoulder was sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Pain
Clinical narrative: body aches; chills; chest pains; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (chills), CHEST PAIN (chest pains) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), CHILLS (chills), CHEST PAIN (chest pains) and HEADACHE (headache). At the time of the report, PAIN (body aches), CHILLS (chills), CHEST PAIN (chest pains) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment includes Tylenol and Advil. Patient was taking Centamin previously but stopped a few month ago.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph node (in armpit)  on the opposite arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (enlarged lymph node (in armpit)  on the opposite arm) in a 22-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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (enlarged lymph node (in armpit)  on the opposite arm). At the time of the report, LYMPHADENOPATHY (enlarged lymph node (in armpit)  on the opposite arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chest pain, Chills, Diarrhoea, Fatigue
Clinical narrative: Chills; Temperature; Diarrhea; Pain in the chest; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), BODY TEMPERATURE INCREASED (Temperature), DIARRHOEA (Diarrhea), CHEST PAIN (Pain in the chest) and FATIGUE (Very tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced CHILLS (Chills), BODY TEMPERATURE INCREASED (Temperature), DIARRHOEA (Diarrhea), CHEST PAIN (Pain in the chest) and FATIGUE (Very tired). At the time of the report, CHILLS (Chills), BODY TEMPERATURE INCREASED (Temperature), DIARRHOEA (Diarrhea), CHEST PAIN (Pain in the chest) and FATIGUE (Very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pruritus
Clinical narrative: Itchy knot; Red knot; Warm to the touch at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy knot), ERYTHEMA (Red knot) and INJECTION SITE WARMTH (Warm to the touch at the site of injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 23-Feb-2021, the patient experienced PRURITUS (Itchy knot), ERYTHEMA (Red knot) and INJECTION SITE WARMTH (Warm to the touch at the site of injection). At the time of the report, PRURITUS (Itchy knot), ERYTHEMA (Red knot) and INJECTION SITE WARMTH (Warm to the touch at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information and concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Lymphadenopathy, Neuralgia
Clinical narrative: Arthritis Pain; Neuropathic Pain; I still have enlarged underarm lymph nodes.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis Pain), NEURALGIA (Neuropathic Pain) and LYMPHADENOPATHY (I still have enlarged underarm lymph nodes.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis since 01-Dec-2020 and Neuropathic pain since 01-Dec-2020.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis Pain), NEURALGIA (Neuropathic Pain) and LYMPHADENOPATHY (I still have enlarged underarm lymph nodes.). At the time of the report, ARTHRITIS (Arthritis Pain) and NEURALGIA (Neuropathic Pain) was resolving and LYMPHADENOPATHY (I still have enlarged underarm lymph nodes.) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received contains added event - Lymphadenopathy and updated outcome from not recovered to recovering
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise
Clinical narrative: doesn't feel well at all today; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (doesn't feel well at all today), HEADACHE (headache) and CHILLS (chills) in a 22-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 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (doesn't feel well at all today), HEADACHE (headache) and CHILLS (chills). At the time of the report, MALAISE (doesn't feel well at all today), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-024388 (Patient Link).