chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: a few aches; bruise; itching; tenderness; redness; slight fatigue "draggy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a few aches), VACCINATION SITE BRUISING (bruise), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (tenderness) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown by patient) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: PREVNAR 13.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN (a few aches), VACCINATION SITE BRUISING (bruise), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (tenderness), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (slight fatigue "draggy). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PAIN (a few aches), VACCINATION SITE BRUISING (bruise), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (tenderness), VACCINATION SITE ERYTHEMA (redness) and FATIGUE (slight fatigue "draggy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction). At the time of the report, VACCINATION COMPLICATION (Adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 99.1F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 99.1F) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (Fever of 99.1F). At the time of the report, PYREXIA (Fever of 99.1F) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Very srtong urine odor; Muscle aches; Threw up; rash is very red/rash all over her face; this rash started being itchy; Rash on her forehead/rash appeared on the side of her face as well; Shaky; Loss of appetite; Felt faint/Lightheaded; Headache; Nausea; Fatigue; Chills really badly; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), RASH ERYTHEMATOUS (rash is very red/rash all over her face), URINE ODOUR ABNORMAL (Very srtong urine odor), RASH PRURITIC (this rash started being itchy) and DECREASED APPETITE (Loss of appetite) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (Chills really badly). On 06-Feb-2021, the patient experienced TREMOR (Shaky), DECREASED APPETITE (Loss of appetite), DIZZINESS (Felt faint/Lightheaded), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 23-Feb-2021, the patient experienced RASH (Rash on her forehead/rash appeared on the side of her face as well). On 28-Feb-2021, the patient experienced RASH PRURITIC (this rash started being itchy). On 01-Mar-2021, the patient experienced RASH ERYTHEMATOUS (rash is very red/rash all over her face). On an unknown date, the patient experienced URINE ODOUR ABNORMAL (Very srtong urine odor), MYALGIA (Muscle aches) and VOMITING (Threw up). At the time of the report, TREMOR (Shaky), RASH ERYTHEMATOUS (rash is very red/rash all over her face), URINE ODOUR ABNORMAL (Very srtong urine odor), RASH PRURITIC (this rash started being itchy), DECREASED APPETITE (Loss of appetite), DIZZINESS (Felt faint/Lightheaded), RASH (Rash on her forehead/rash appeared on the side of her face as well), CHILLS (Chills really badly), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Muscle aches) and VOMITING (Threw up) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: significant followup received on 28-jul-2021 in which AE were added and contact details were updated
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Very srtong urine odor; Muscle aches; Threw up; rash is very red/rash all over her face; this rash started being itchy; Rash on her forehead/rash appeared on the side of her face as well; Shaky; Loss of appetite; Felt faint/Lightheaded; Headache; Nausea; Fatigue; Chills really badly; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), RASH ERYTHEMATOUS (rash is very red/rash all over her face), URINE ODOUR ABNORMAL (Very srtong urine odor), RASH PRURITIC (this rash started being itchy) and DECREASED APPETITE (Loss of appetite) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (Chills really badly). On 06-Feb-2021, the patient experienced TREMOR (Shaky), DECREASED APPETITE (Loss of appetite), DIZZINESS (Felt faint/Lightheaded), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 23-Feb-2021, the patient experienced RASH (Rash on her forehead/rash appeared on the side of her face as well). On 28-Feb-2021, the patient experienced RASH PRURITIC (this rash started being itchy). On 01-Mar-2021, the patient experienced RASH ERYTHEMATOUS (rash is very red/rash all over her face). On an unknown date, the patient experienced URINE ODOUR ABNORMAL (Very srtong urine odor), MYALGIA (Muscle aches) and VOMITING (Threw up). At the time of the report, TREMOR (Shaky), RASH ERYTHEMATOUS (rash is very red/rash all over her face), URINE ODOUR ABNORMAL (Very srtong urine odor), RASH PRURITIC (this rash started being itchy), DECREASED APPETITE (Loss of appetite), DIZZINESS (Felt faint/Lightheaded), RASH (Rash on her forehead/rash appeared on the side of her face as well), CHILLS (Chills really badly), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Muscle aches) and VOMITING (Threw up) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: significant followup received on 28-jul-2021 in which AE were added and contact details were updated
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Urine odour abnormal, Vomiting
Clinical narrative: Very srtong urine odor; Muscle aches; Threw up; rash is very red/rash all over her face; this rash started being itchy; Rash on her forehead/rash appeared on the side of her face as well; Shaky; Loss of appetite; Felt faint/Lightheaded; Headache; Nausea; Fatigue; Chills really badly; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), RASH ERYTHEMATOUS (rash is very red/rash all over her face), URINE ODOUR ABNORMAL (Very srtong urine odor), RASH PRURITIC (this rash started being itchy) and DECREASED APPETITE (Loss of appetite) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (Chills really badly). On 06-Feb-2021, the patient experienced TREMOR (Shaky), DECREASED APPETITE (Loss of appetite), DIZZINESS (Felt faint/Lightheaded), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 23-Feb-2021, the patient experienced RASH (Rash on her forehead/rash appeared on the side of her face as well). On 28-Feb-2021, the patient experienced RASH PRURITIC (this rash started being itchy). On 01-Mar-2021, the patient experienced RASH ERYTHEMATOUS (rash is very red/rash all over her face). On an unknown date, the patient experienced URINE ODOUR ABNORMAL (Very srtong urine odor), MYALGIA (Muscle aches) and VOMITING (Threw up). At the time of the report, TREMOR (Shaky), RASH ERYTHEMATOUS (rash is very red/rash all over her face), URINE ODOUR ABNORMAL (Very srtong urine odor), RASH PRURITIC (this rash started being itchy), DECREASED APPETITE (Loss of appetite), DIZZINESS (Felt faint/Lightheaded), RASH (Rash on her forehead/rash appeared on the side of her face as well), CHILLS (Chills really badly), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), MYALGIA (Muscle aches) and VOMITING (Threw up) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: significant followup received on 28-jul-2021 in which AE were added and contact details were updated
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Peripheral swelling, Pruritus, Rhinorrhoea
Clinical narrative: Itching all over her head, neck and arms/Extreme itchiness; Runny nose; Felt like she had a mild cold; Muscle pain; Underarm swelling of her lymph nodes; Raised red spot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain) and PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-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 PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain), PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) and VACCINATION SITE ERYTHEMA (Raised red spot on her arm). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain), PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) and VACCINATION SITE ERYTHEMA (Raised red spot on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Itching all over her head, neck and arms/Extreme itchiness; Runny nose; Felt like she had a mild cold; Muscle pain; Underarm swelling of her lymph nodes; Raised red spot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain) and PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-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 PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain), PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) and VACCINATION SITE ERYTHEMA (Raised red spot on her arm). The patient was treated with PARACETAMOL (TYLENOL) for Muscle pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all over her head, neck and arms/Extreme itchiness), RHINORRHOEA (Runny nose), NASOPHARYNGITIS (Felt like she had a mild cold), MYALGIA (Muscle pain), PERIPHERAL SWELLING (Underarm swelling of her lymph nodes) and VACCINATION SITE ERYTHEMA (Raised red spot on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Infection, Pain, Pruritus, Rash macular, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Delayed reaction red spot), INFECTION (infection), SWELLING (Delayed reaction swelling), PRURITUS (Delayed reaction itching) and PAIN (Delayed reaction pain) 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced RASH MACULAR (Delayed reaction red spot), SWELLING (Delayed reaction swelling), PRURITUS (Delayed reaction itching) and PAIN (Delayed reaction pain). On 14-Feb-2021, the patient experienced INFECTION (infection). The patient was treated with CEFALEXIN (CEPHALEXINE) (oral) at a dose of 500 mg. At the time of the report, RASH MACULAR (Delayed reaction red spot), INFECTION (infection), SWELLING (Delayed reaction swelling), PRURITUS (Delayed reaction itching) and PAIN (Delayed reaction pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Pyrexia
Clinical narrative: headache; fever; can't move her arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever) and LIMB DISCOMFORT (can't move her arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included normal medications 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 16-Feb-2021, the patient experienced HEADACHE (headache), PYREXIA (fever) and LIMB DISCOMFORT (can't move her arm). At the time of the report, HEADACHE (headache), PYREXIA (fever) and LIMB DISCOMFORT (can't move her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: strange side effect 8 days later; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strange side effect 8 days later) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (strange side effect 8 days later). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (strange side effect 8 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-092609, US-MODERNATX, INC.-MOD-2021-091728 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091728: Phone number is matching in this case with mothers case US-MODERNATX, INC.-MOD-2021-092609: Phone number is same in mother case and this case
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Oral pain
Clinical narrative: Patient developed blisters and sores in her mouth; Patient developed blisters and sores in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Patient developed blisters and sores in her mouth) and ORAL PAIN (Patient developed blisters and sores in her mouth) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03HK20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced BLISTER (Patient developed blisters and sores in her mouth) and ORAL PAIN (Patient developed blisters and sores in her mouth). At the time of the report, BLISTER (Patient developed blisters and sores in her mouth) and ORAL PAIN (Patient developed blisters and sores in her mouth) outcome was unknown.            Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Insomnia, Pain
Clinical narrative: insomnia; pain; soreness; redspot; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PAIN (pain), INJECTION SITE PAIN (soreness), ERYTHEMA (redspot) and INSOMNIA (insomnia) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Hypertension, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 13-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 13-Jan-2021, the patient experienced PAIN (pain), INJECTION SITE PAIN (soreness) and ERYTHEMA (redspot). On 09-Feb-2021, the patient experienced INSOMNIA (insomnia). On 13-Jan-2021, PAIN (pain), INJECTION SITE PAIN (soreness) and ERYTHEMA (redspot) had resolved. At the time of the report, INSOMNIA (insomnia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Pain
Clinical narrative: Aching; Hurting on the joints; Not feeling well; Body soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching), ARTHRALGIA (Hurting on the joints), MALAISE (Not feeling well) and ARTHRALGIA (Body soreness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (Aching), ARTHRALGIA (Hurting on the joints), MALAISE (Not feeling well) and ARTHRALGIA (Body soreness). At the time of the report, PAIN (Aching), ARTHRALGIA (Hurting on the joints), MALAISE (Not feeling well) and ARTHRALGIA (Body soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details included None
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Injection site pain, Injection site warmth
Clinical narrative: fever; soreness at injection site; chills; pain at injection site; warmth at injection site; headache; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), INJECTION SITE PAIN (pain at injection site), INJECTION SITE WARMTH (warmth at injection site), HEADACHE (headache) and DIZZINESS (lightheadedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE BESILATE (NORVASC), ATENOLOL and FAMOTIDINE 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 16-Feb-2021, the patient experienced CHILLS (chills), INJECTION SITE PAIN (pain at injection site), INJECTION SITE WARMTH (warmth at injection site), HEADACHE (headache), DIZZINESS (lightheadedness) and INJECTION SITE PAIN (soreness at injection site). On 17-Feb-2021, the patient experienced PYREXIA (fever). On 17-Feb-2021, CHILLS (chills), INJECTION SITE PAIN (pain at injection site), INJECTION SITE WARMTH (warmth at injection site), HEADACHE (headache) and DIZZINESS (lightheadedness) had resolved. At the time of the report, PYREXIA (fever) and INJECTION SITE PAIN (soreness at injection site) 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: Pyrexia
Clinical narrative: fever; soreness at injection site; chills; pain at injection site; warmth at injection site; headache; lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), INJECTION SITE PAIN (pain at injection site), INJECTION SITE WARMTH (warmth at injection site), HEADACHE (headache) and DIZZINESS (lightheadedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE BESILATE (NORVASC), ATENOLOL and FAMOTIDINE 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 16-Feb-2021, the patient experienced CHILLS (chills), INJECTION SITE PAIN (pain at injection site), INJECTION SITE WARMTH (warmth at injection site), HEADACHE (headache), DIZZINESS (lightheadedness) and INJECTION SITE PAIN (soreness at injection site). On 17-Feb-2021, the patient experienced PYREXIA (fever). On 17-Feb-2021, CHILLS (chills), INJECTION SITE PAIN (pain at injection site), INJECTION SITE WARMTH (warmth at injection site), HEADACHE (headache) and DIZZINESS (lightheadedness) had resolved. At the time of the report, PYREXIA (fever) and INJECTION SITE PAIN (soreness at injection site) 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: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included rest, ice, and elevation
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19 after vaccination; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for COVID-19 after vaccination) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after vaccination). At the time of the report, COVID-19 (Tested positive for COVID-19 after vaccination) 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.   Treatment details included Not sure. Concomitant medications reported were Not sure for drug use for unknown indication.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Big cluster swelling all over his body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Big cluster swelling all over his body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-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 07-Feb-2021, the patient experienced SWELLING (Big cluster swelling all over his body). The patient was treated with PREDNISONE for Swelling, at an unspecified dose and frequency. At the time of the report, SWELLING (Big cluster swelling all over his body) had resolved.            patient said he took prednisone and his swelling went away after a couple of days, he is fine now and had no other AE   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional info was updated with outcome of the event.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection Site Pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection Site Pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE PAIN (Injection Site Pain). On 13-Feb-2021, INJECTION SITE PAIN (Injection Site Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Vomiting
Clinical narrative: cold chills; vomiting; arm sore; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PAIN (arm sore), CHILLS (cold chills) and VOMITING (vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 immunisation.     The patient's past medical history included No adverse reaction. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) 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 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (arm sore). On 13-Feb-2021, the patient experienced CHILLS (cold chills) and VOMITING (vomiting). At the time of the report, INJECTION SITE PAIN (arm sore), CHILLS (cold chills) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Nasopharyngitis, Pain
Clinical narrative: Body aches; cold; cough; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PAIN (Body aches), NASOPHARYNGITIS (cold) and COUGH (cough) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (chills), PAIN (Body aches), NASOPHARYNGITIS (cold) and COUGH (cough). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), PAIN (Body aches), NASOPHARYNGITIS (cold) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Influenza like illness, Lymphadenopathy, Peripheral swelling
Clinical narrative: Swollen arm; Red arm; Flu like symptoms; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red arm), INFLUENZA LIKE ILLNESS (Flu like symptoms) and LYMPHADENOPATHY (Swollen lymph nodes) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red arm), INFLUENZA LIKE ILLNESS (Flu like symptoms) and LYMPHADENOPATHY (Swollen lymph nodes). On 13-Feb-2021, LYMPHADENOPATHY (Swollen lymph nodes) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Red arm) and INFLUENZA LIKE ILLNESS (Flu like symptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bed rest, Fatigue, Headache, Influenza like illness
Clinical narrative: sore arm; headache little bit; FLU LIKE SYMPTOMS; WEAKNESS; stayed in the whole day; tired,weakness; FEVER OF 101.1; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), ASTHENIA (WEAKNESS), PAIN IN EXTREMITY (sore arm), BED REST (stayed in the whole day) and FATIGUE (tired,weakness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included AZITHROMYCIN, ETHAMBUTOL and AMIKACIN SULFATE (ARIKAYCE) for an unknown indication.   On 14-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 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), ASTHENIA (WEAKNESS), BED REST (stayed in the whole day), FATIGUE (tired,weakness) and PYREXIA (FEVER OF 101.1). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache little bit). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), ASTHENIA (WEAKNESS), PAIN IN EXTREMITY (sore arm), BED REST (stayed in the whole day), FATIGUE (tired,weakness), PYREXIA (FEVER OF 101.1) and HEADACHE (headache little bit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.1 101.1.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; headache little bit; FLU LIKE SYMPTOMS; WEAKNESS; stayed in the whole day; tired,weakness; FEVER OF 101.1; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), ASTHENIA (WEAKNESS), PAIN IN EXTREMITY (sore arm), BED REST (stayed in the whole day) and FATIGUE (tired,weakness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included AZITHROMYCIN, ETHAMBUTOL and AMIKACIN SULFATE (ARIKAYCE) for an unknown indication.   On 14-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 14-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), ASTHENIA (WEAKNESS), BED REST (stayed in the whole day), FATIGUE (tired,weakness) and PYREXIA (FEVER OF 101.1). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (headache little bit). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), ASTHENIA (WEAKNESS), PAIN IN EXTREMITY (sore arm), BED REST (stayed in the whole day), FATIGUE (tired,weakness), PYREXIA (FEVER OF 101.1) and HEADACHE (headache little bit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.1 101.1.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle spasms, Myalgia
Clinical narrative: LEG CRAMPS,WORSEN AND GOT UP TO HER GROIN; MUSCLE ACHES; KNEE AND JOINT PAIN; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (LEG CRAMPS,WORSEN AND GOT UP TO HER GROIN), MYALGIA (MUSCLE ACHES) and ARTHRALGIA (KNEE AND JOINT PAIN) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (Bilateral knee replacement surgery.).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MUSCLE SPASMS (LEG CRAMPS,WORSEN AND GOT UP TO HER GROIN), MYALGIA (MUSCLE ACHES) and ARTHRALGIA (KNEE AND JOINT PAIN). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 12-Feb-2021 at a dose of 1 dosage form. At the time of the report, MUSCLE SPASMS (LEG CRAMPS,WORSEN AND GOT UP TO HER GROIN), MYALGIA (MUSCLE ACHES) and ARTHRALGIA (KNEE AND JOINT PAIN) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medications includes topical analgesics, ice. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-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 ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported.  Upon internal review on 21-May-2021, the age was corrected to unknown.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: hot; Hardness; slight itching; Redness/ size of dollar bill and blotchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot), INJECTION SITE INDURATION (Hardness), INJECTION SITE PRURITUS (slight itching) and INJECTION SITE ERYTHEMA (Redness/ size of dollar bill and blotchy) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot), INJECTION SITE INDURATION (Hardness), INJECTION SITE PRURITUS (slight itching) and INJECTION SITE ERYTHEMA (Redness/ size of dollar bill and blotchy). On 04-Feb-2021, INJECTION SITE WARMTH (hot), INJECTION SITE INDURATION (Hardness), INJECTION SITE PRURITUS (slight itching) and INJECTION SITE ERYTHEMA (Redness/ size of dollar bill and blotchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.~  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR - event outcome added
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chill; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chill) and PYREXIA (fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 15-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 CHILLS (chill) and PYREXIA (fever). At the time of the report, CHILLS (chill) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm sore and is very bad; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore and is very bad) and PYREXIA (Fever) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore and is very bad) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm sore and is very bad) and PYREXIA (Fever) outcome was unknown. Not Provided          Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 029K20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included APIXABAN (ELIQUIS), CARVEDILOL, PRAVASTATIN, EZETIMIBE (ZETIA), CALCITRIOL, eylea injections and LATANOPROST for an unknown indication.   On 16-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 16-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site reaction
Clinical narrative: spots that come and go; itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (spots that come and go) and INJECTION SITE PRURITUS (itching) 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 21-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 INJECTION SITE REACTION (spots that come and go) and INJECTION SITE PRURITUS (itching). At the time of the report, INJECTION SITE REACTION (spots that come and go) and INJECTION SITE PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Updated Reporter Information
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills; fever; general body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and MYALGIA (general body aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for an unknown indication.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 05-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 CHILLS (chills), PYREXIA (fever) and MYALGIA (general body aches). At the time of the report, CHILLS (chills), PYREXIA (fever) and MYALGIA (general body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Red rash around injection site 6 inches diameter and hard underneath; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Red rash around injection site 6 inches diameter and hard underneath) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE RASH (Red rash around injection site 6 inches diameter and hard underneath). At the time of the report, INJECTION SITE RASH (Red rash around injection site 6 inches diameter and hard underneath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.