chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain in chest , headaches , body aches; Pain in chest , headaches , body aches; Pain in chest , headaches , body aches; Fatigue; Fever (101.8 °F); This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in chest , headaches , body aches), PAIN (Pain in chest , headaches , body aches), HEADACHE (Pain in chest , headaches , body aches), FATIGUE (Fatigue) and PYREXIA (Fever (101.8 °F)) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced CHEST PAIN (Pain in chest , headaches , body aches), PAIN (Pain in chest , headaches , body aches), HEADACHE (Pain in chest , headaches , body aches), FATIGUE (Fatigue) and PYREXIA (Fever (101.8 °F)). At the time of the report, CHEST PAIN (Pain in chest , headaches , body aches), PAIN (Pain in chest , headaches , body aches), HEADACHE (Pain in chest , headaches , body aches), FATIGUE (Fatigue) and PYREXIA (Fever (101.8 °F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the available current information and the temporal association of the use of the product and the start of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the available current information and the temporal association of the use of the product and the start of the events a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Facial pain, Fall, Headache
Clinical narrative: eye balls are sunken; face hurts; fallen down a few times; hurting all over; nausea; fever of 99 degrees Fahrenheit; dizziness; spine hurt; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (spine hurt), DIZZINESS (dizziness), EYE PAIN (eye balls are sunken), FACIAL PAIN (face hurts) and FALL (fallen down a few times) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced SPINAL PAIN (spine hurt), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 25-Mar-2021, the patient experienced DIZZINESS (dizziness), PAIN (hurting all over), NAUSEA (nausea) and PYREXIA (fever of 99 degrees Fahrenheit). On 26-Mar-2021, the patient experienced EYE PAIN (eye balls are sunken), FACIAL PAIN (face hurts) and FALL (fallen down a few times). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SPINAL PAIN (spine hurt), DIZZINESS (dizziness), EYE PAIN (eye balls are sunken), FACIAL PAIN (face hurts), FALL (fallen down a few times), PAIN IN EXTREMITY (sore arm), PAIN (hurting all over), NAUSEA (nausea), PYREXIA (fever of 99 degrees Fahrenheit) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information includes iced arm.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Spinal pain
Clinical narrative: eye balls are sunken; face hurts; fallen down a few times; hurting all over; nausea; fever of 99 degrees Fahrenheit; dizziness; spine hurt; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL PAIN (spine hurt), DIZZINESS (dizziness), EYE PAIN (eye balls are sunken), FACIAL PAIN (face hurts) and FALL (fallen down a few times) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced SPINAL PAIN (spine hurt), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). On 25-Mar-2021, the patient experienced DIZZINESS (dizziness), PAIN (hurting all over), NAUSEA (nausea) and PYREXIA (fever of 99 degrees Fahrenheit). On 26-Mar-2021, the patient experienced EYE PAIN (eye balls are sunken), FACIAL PAIN (face hurts) and FALL (fallen down a few times). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SPINAL PAIN (spine hurt), DIZZINESS (dizziness), EYE PAIN (eye balls are sunken), FACIAL PAIN (face hurts), FALL (fallen down a few times), PAIN IN EXTREMITY (sore arm), PAIN (hurting all over), NAUSEA (nausea), PYREXIA (fever of 99 degrees Fahrenheit) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information includes iced arm.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: Feels like she's getting the flu after 2nd dose; Arm hurting really bad after 2nd dose; Arm swollen after 2nd dose; Arm hot after 2nd dose; Arm red after 2nd dose; Bad headache after 2nd dose; Fever of 101.4 F after 2nd dose; Fatigue after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like she's getting the flu after 2nd dose), PAIN IN EXTREMITY (Arm hurting really bad after 2nd dose), PERIPHERAL SWELLING (Arm swollen after 2nd dose), FEELING HOT (Arm hot after 2nd dose) and ERYTHEMA (Arm red after 2nd dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 27b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-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. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like she's getting the flu after 2nd dose), PAIN IN EXTREMITY (Arm hurting really bad after 2nd dose), PERIPHERAL SWELLING (Arm swollen after 2nd dose), FEELING HOT (Arm hot after 2nd dose), ERYTHEMA (Arm red after 2nd dose), HEADACHE (Bad headache after 2nd dose), PYREXIA (Fever of 101.4 F after 2nd dose) and FATIGUE (Fatigue after 2nd dose). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Feels like she's getting the flu after 2nd dose), PAIN IN EXTREMITY (Arm hurting really bad after 2nd dose), PERIPHERAL SWELLING (Arm swollen after 2nd dose), FEELING HOT (Arm hot after 2nd dose), ERYTHEMA (Arm red after 2nd dose), HEADACHE (Bad headache after 2nd dose), PYREXIA (Fever of 101.4 F after 2nd dose) and FATIGUE (Fatigue after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 f (High) 101.4 F.         Treatment medications include Ice pack. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Feels like she's getting the flu after 2nd dose; Arm hurting really bad after 2nd dose; Arm swollen after 2nd dose; Arm hot after 2nd dose; Arm red after 2nd dose; Bad headache after 2nd dose; Fever of 101.4 F after 2nd dose; Fatigue after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like she's getting the flu after 2nd dose), PAIN IN EXTREMITY (Arm hurting really bad after 2nd dose), PERIPHERAL SWELLING (Arm swollen after 2nd dose), FEELING HOT (Arm hot after 2nd dose) and ERYTHEMA (Arm red after 2nd dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 27b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-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. In April 2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like she's getting the flu after 2nd dose), PAIN IN EXTREMITY (Arm hurting really bad after 2nd dose), PERIPHERAL SWELLING (Arm swollen after 2nd dose), FEELING HOT (Arm hot after 2nd dose), ERYTHEMA (Arm red after 2nd dose), HEADACHE (Bad headache after 2nd dose), PYREXIA (Fever of 101.4 F after 2nd dose) and FATIGUE (Fatigue after 2nd dose). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Feels like she's getting the flu after 2nd dose), PAIN IN EXTREMITY (Arm hurting really bad after 2nd dose), PERIPHERAL SWELLING (Arm swollen after 2nd dose), FEELING HOT (Arm hot after 2nd dose), ERYTHEMA (Arm red after 2nd dose), HEADACHE (Bad headache after 2nd dose), PYREXIA (Fever of 101.4 F after 2nd dose) and FATIGUE (Fatigue after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 f (High) 101.4 F.         Treatment medications include Ice pack. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: SORENESS; FEVER; SWELLING AT INJECTION SITE; FATIGUE; CHILLS; NAUSEA; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (SORENESS), PYREXIA (FEVER), VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE), FATIGUE (FATIGUE) and CHILLS (CHILLS) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced NAUSEA (NAUSEA). On an unknown date, the patient experienced PAIN (SORENESS), PYREXIA (FEVER), VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE), FATIGUE (FATIGUE) and CHILLS (CHILLS). At the time of the report, PAIN (SORENESS), PYREXIA (FEVER), VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE), FATIGUE (FATIGUE), CHILLS (CHILLS) and NAUSEA (NAUSEA) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: SORENESS; FEVER; SWELLING AT INJECTION SITE; FATIGUE; CHILLS; NAUSEA; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (SORENESS), PYREXIA (FEVER), VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE), FATIGUE (FATIGUE) and CHILLS (CHILLS) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced NAUSEA (NAUSEA). On an unknown date, the patient experienced PAIN (SORENESS), PYREXIA (FEVER), VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE), FATIGUE (FATIGUE) and CHILLS (CHILLS). At the time of the report, PAIN (SORENESS), PYREXIA (FEVER), VACCINATION SITE SWELLING (SWELLING AT INJECTION SITE), FATIGUE (FATIGUE), CHILLS (CHILLS) and NAUSEA (NAUSEA) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Little fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Little fever) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M2OA and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (Little fever). At the time of the report, PYREXIA (Little fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   This case was linked to MOD-2021-066273 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Pain in her arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm) and HEADACHE (Headache) 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 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in her arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Fatigue, Mouth ulceration, Musculoskeletal stiffness, Myalgia
Clinical narrative: Her tongue began swelling; There were ulcers on the side of her tongue; She had blurriness.; She had a film over her; Discharge coming out of her eyes; Her eye appeared red 5 days later.; Rash at injection site; Acheness; Stiff neck; Really exhausted; Soreness; She also had nausea.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had blurriness.), SWOLLEN TONGUE (Her tongue began swelling) and MOUTH ULCERATION (There were ulcers on the side of her tongue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease. Previously administered products included for an unreported indication: TETANUS VACCINE (14 days before covid-19 vaccine.) on 23-Feb-2021.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck), FATIGUE (Really exhausted), PAIN (Soreness), NAUSEA (She also had nausea.) and MYALGIA (Acheness). On 14-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had a film over her), EYE DISCHARGE (Discharge coming out of her eyes) and VACCINATION SITE RASH (Rash at injection site). On 17-Mar-2021, the patient experienced VISION BLURRED (She had blurriness.). On 18-Mar-2021, the patient experienced SWOLLEN TONGUE (Her tongue began swelling) and MOUTH ULCERATION (There were ulcers on the side of her tongue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck), OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had blurriness.), SWOLLEN TONGUE (Her tongue began swelling), MOUTH ULCERATION (There were ulcers on the side of her tongue), VISION BLURRED (She had a film over her), EYE DISCHARGE (Discharge coming out of her eyes), FATIGUE (Really exhausted), PAIN (Soreness), NAUSEA (She also had nausea.), VACCINATION SITE RASH (Rash at injection site) and MYALGIA (Acheness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Streptococcus test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not provided.  The patient was scheduled with 2nd dose on 06-APR-2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ocular hyperaemia, Pain, SARS-CoV-2 test, Streptococcus test
Clinical narrative: Her tongue began swelling; There were ulcers on the side of her tongue; She had blurriness.; She had a film over her; Discharge coming out of her eyes; Her eye appeared red 5 days later.; Rash at injection site; Acheness; Stiff neck; Really exhausted; Soreness; She also had nausea.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had blurriness.), SWOLLEN TONGUE (Her tongue began swelling) and MOUTH ULCERATION (There were ulcers on the side of her tongue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease. Previously administered products included for an unreported indication: TETANUS VACCINE (14 days before covid-19 vaccine.) on 23-Feb-2021.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck), FATIGUE (Really exhausted), PAIN (Soreness), NAUSEA (She also had nausea.) and MYALGIA (Acheness). On 14-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had a film over her), EYE DISCHARGE (Discharge coming out of her eyes) and VACCINATION SITE RASH (Rash at injection site). On 17-Mar-2021, the patient experienced VISION BLURRED (She had blurriness.). On 18-Mar-2021, the patient experienced SWOLLEN TONGUE (Her tongue began swelling) and MOUTH ULCERATION (There were ulcers on the side of her tongue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck), OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had blurriness.), SWOLLEN TONGUE (Her tongue began swelling), MOUTH ULCERATION (There were ulcers on the side of her tongue), VISION BLURRED (She had a film over her), EYE DISCHARGE (Discharge coming out of her eyes), FATIGUE (Really exhausted), PAIN (Soreness), NAUSEA (She also had nausea.), VACCINATION SITE RASH (Rash at injection site) and MYALGIA (Acheness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Streptococcus test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not provided.  The patient was scheduled with 2nd dose on 06-APR-2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Vaccination site rash, Vision blurred
Clinical narrative: Her tongue began swelling; There were ulcers on the side of her tongue; She had blurriness.; She had a film over her; Discharge coming out of her eyes; Her eye appeared red 5 days later.; Rash at injection site; Acheness; Stiff neck; Really exhausted; Soreness; She also had nausea.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had blurriness.), SWOLLEN TONGUE (Her tongue began swelling) and MOUTH ULCERATION (There were ulcers on the side of her tongue) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lyme disease. Previously administered products included for an unreported indication: TETANUS VACCINE (14 days before covid-19 vaccine.) on 23-Feb-2021.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck), FATIGUE (Really exhausted), PAIN (Soreness), NAUSEA (She also had nausea.) and MYALGIA (Acheness). On 14-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had a film over her), EYE DISCHARGE (Discharge coming out of her eyes) and VACCINATION SITE RASH (Rash at injection site). On 17-Mar-2021, the patient experienced VISION BLURRED (She had blurriness.). On 18-Mar-2021, the patient experienced SWOLLEN TONGUE (Her tongue began swelling) and MOUTH ULCERATION (There were ulcers on the side of her tongue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck), OCULAR HYPERAEMIA (Her eye appeared red 5 days later.), VISION BLURRED (She had blurriness.), SWOLLEN TONGUE (Her tongue began swelling), MOUTH ULCERATION (There were ulcers on the side of her tongue), VISION BLURRED (She had a film over her), EYE DISCHARGE (Discharge coming out of her eyes), FATIGUE (Really exhausted), PAIN (Soreness), NAUSEA (She also had nausea.), VACCINATION SITE RASH (Rash at injection site) and MYALGIA (Acheness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Streptococcus test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not provided.  The patient was scheduled with 2nd dose on 06-APR-2021.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: chills; "headachy"; problems with balance; doesn't feel good; more pain than normal; chest pain, "not like heart pain" more like acid reflux.; a lot of fatigue; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (problems with balance), FEELING ABNORMAL (doesn't feel good), PAIN (more pain than normal), NON-CARDIAC CHEST PAIN (chest pain, "not like heart pain" more like acid reflux.) and FATIGUE (a lot of fatigue) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032n20a and 001a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache, GERD, Vertigo and Heart attack. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, GLIMEPIRIDE (AMARYL), MECLIZINE HCL, METFORMIN, PREGABALIN, ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL, LOSARTAN, PANTOPRAZOLE and PARACETAMOL (TYLENOL) for an unknown indication, ACETYLSALICYLIC ACID (ASPIRIN LOW).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced BALANCE DISORDER (problems with balance), FEELING ABNORMAL (doesn't feel good), PAIN (more pain than normal), NON-CARDIAC CHEST PAIN (chest pain, "not like heart pain" more like acid reflux.), FATIGUE (a lot of fatigue), NAUSEA (nauseous) and HEADACHE ("headachy"). On 29-Mar-2021, the patient experienced CHILLS (chills). On 30-Mar-2021, CHILLS (chills) had resolved. At the time of the report, BALANCE DISORDER (problems with balance), FEELING ABNORMAL (doesn't feel good), PAIN (more pain than normal), NON-CARDIAC CHEST PAIN (chest pain, "not like heart pain" more like acid reflux.), FATIGUE (a lot of fatigue), NAUSEA (nauseous) and HEADACHE ("headachy") outcome was unknown.            Other concomitant product also include low dose aspirin, hydrochloroprol , invocana.  On 30 Mar 2021, the patient under gone lab test included blood work and urine test. However the results were unknown.  Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Non-cardiac chest pain, Pain
Clinical narrative: chills; "headachy"; problems with balance; doesn't feel good; more pain than normal; chest pain, "not like heart pain" more like acid reflux.; a lot of fatigue; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (problems with balance), FEELING ABNORMAL (doesn't feel good), PAIN (more pain than normal), NON-CARDIAC CHEST PAIN (chest pain, "not like heart pain" more like acid reflux.) and FATIGUE (a lot of fatigue) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032n20a and 001a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache, GERD, Vertigo and Heart attack. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, GLIMEPIRIDE (AMARYL), MECLIZINE HCL, METFORMIN, PREGABALIN, ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL, LOSARTAN, PANTOPRAZOLE and PARACETAMOL (TYLENOL) for an unknown indication, ACETYLSALICYLIC ACID (ASPIRIN LOW).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced BALANCE DISORDER (problems with balance), FEELING ABNORMAL (doesn't feel good), PAIN (more pain than normal), NON-CARDIAC CHEST PAIN (chest pain, "not like heart pain" more like acid reflux.), FATIGUE (a lot of fatigue), NAUSEA (nauseous) and HEADACHE ("headachy"). On 29-Mar-2021, the patient experienced CHILLS (chills). On 30-Mar-2021, CHILLS (chills) had resolved. At the time of the report, BALANCE DISORDER (problems with balance), FEELING ABNORMAL (doesn't feel good), PAIN (more pain than normal), NON-CARDIAC CHEST PAIN (chest pain, "not like heart pain" more like acid reflux.), FATIGUE (a lot of fatigue), NAUSEA (nauseous) and HEADACHE ("headachy") outcome was unknown.            Other concomitant product also include low dose aspirin, hydrochloroprol , invocana.  On 30 Mar 2021, the patient under gone lab test included blood work and urine test. However the results were unknown.  Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: Did a COVID test and tested positive; Sluggish; Lots of coughing; No appetite; Feeling sick and took nearly two weeks to recover; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Did a COVID test and tested positive), SLUGGISHNESS (Sluggish), COUGH (Lots of coughing), DECREASED APPETITE (No appetite) and MALAISE (Feeling sick and took nearly two weeks to recover) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced SLUGGISHNESS (Sluggish), COUGH (Lots of coughing), DECREASED APPETITE (No appetite), MALAISE (Feeling sick and took nearly two weeks to recover) and PYREXIA (Fever). On 01-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Did a COVID test and tested positive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Did a COVID test and tested positive), SLUGGISHNESS (Sluggish), COUGH (Lots of coughing), DECREASED APPETITE (No appetite) and PYREXIA (Fever) outcome was unknown and MALAISE (Feeling sick and took nearly two weeks to recover) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included paracetamol and cough medicine.   This case was linked to MOD-2021-066366 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sluggishness
Clinical narrative: Did a COVID test and tested positive; Sluggish; Lots of coughing; No appetite; Feeling sick and took nearly two weeks to recover; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Did a COVID test and tested positive), SLUGGISHNESS (Sluggish), COUGH (Lots of coughing), DECREASED APPETITE (No appetite) and MALAISE (Feeling sick and took nearly two weeks to recover) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced SLUGGISHNESS (Sluggish), COUGH (Lots of coughing), DECREASED APPETITE (No appetite), MALAISE (Feeling sick and took nearly two weeks to recover) and PYREXIA (Fever). On 01-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Did a COVID test and tested positive). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Did a COVID test and tested positive), SLUGGISHNESS (Sluggish), COUGH (Lots of coughing), DECREASED APPETITE (No appetite) and PYREXIA (Fever) outcome was unknown and MALAISE (Feeling sick and took nearly two weeks to recover) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included paracetamol and cough medicine.   This case was linked to MOD-2021-066366 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site erythema, Vaccination site nodule, Vaccination site warmth
Clinical narrative: swelling is increasing; injection site is hot to touch; redness; hard lump to injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling is increasing), VACCINATION SITE NODULE (hard lump to injection site), VACCINATION SITE WARMTH (injection site is hot to touch) and VACCINATION SITE ERYTHEMA (redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE NODULE (hard lump to injection site). On 22-Mar-2021, the patient experienced SWELLING (swelling is increasing), VACCINATION SITE WARMTH (injection site is hot to touch) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, SWELLING (swelling is increasing), VACCINATION SITE NODULE (hard lump to injection site), VACCINATION SITE WARMTH (injection site is hot to touch) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea
Clinical narrative: Extreme weakness; a lot of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extreme weakness) and DIARRHOEA (a lot of diarrhea) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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-Apr-2021, the patient experienced ASTHENIA (Extreme weakness) and DIARRHOEA (a lot of diarrhea). At the time of the report, ASTHENIA (Extreme weakness) and DIARRHOEA (a lot of diarrhea) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Euphoric mood, Fatigue, Parosmia
Clinical narrative: hypernosmia/Strong Sense of Smell; dizziness; euphoric feeling; fatigue; fever; Uncontrolled restless leg; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (euphoric feeling), FATIGUE (fatigue), PYREXIA (fever), DIZZINESS (dizziness) and PAROSMIA (hypernosmia/Strong Sense of Smell) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Restless legs syndrome. Concomitant products included CLONAZEPAM (KLONOPIN), ROPINIROLE and TRAZODONE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 02-Mar-2021, the patient experienced EUPHORIC MOOD (euphoric feeling), FATIGUE (fatigue) and PYREXIA (fever). In March 2021, the patient experienced RESTLESS LEGS SYNDROME (Uncontrolled restless leg). On 04-Apr-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced PAROSMIA (hypernosmia/Strong Sense of Smell). On 02-Mar-2021, EUPHORIC MOOD (euphoric feeling) had resolved. On 03-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, PYREXIA (fever), DIZZINESS (dizziness) and PAROSMIA (hypernosmia/Strong Sense of Smell) outcome was unknown and RESTLESS LEGS SYNDROME (Uncontrolled restless leg) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided with Celecoxib, Unspecified Opioid, Valerian drops, passion flower and black cherry.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Restless legs syndrome
Clinical narrative: hypernosmia/Strong Sense of Smell; dizziness; euphoric feeling; fatigue; fever; Uncontrolled restless leg; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (euphoric feeling), FATIGUE (fatigue), PYREXIA (fever), DIZZINESS (dizziness) and PAROSMIA (hypernosmia/Strong Sense of Smell) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Restless legs syndrome. Concomitant products included CLONAZEPAM (KLONOPIN), ROPINIROLE and TRAZODONE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 02-Mar-2021, the patient experienced EUPHORIC MOOD (euphoric feeling), FATIGUE (fatigue) and PYREXIA (fever). In March 2021, the patient experienced RESTLESS LEGS SYNDROME (Uncontrolled restless leg). On 04-Apr-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced PAROSMIA (hypernosmia/Strong Sense of Smell). On 02-Mar-2021, EUPHORIC MOOD (euphoric feeling) had resolved. On 03-Mar-2021, FATIGUE (fatigue) had resolved. At the time of the report, PYREXIA (fever), DIZZINESS (dizziness) and PAROSMIA (hypernosmia/Strong Sense of Smell) outcome was unknown and RESTLESS LEGS SYNDROME (Uncontrolled restless leg) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided with Celecoxib, Unspecified Opioid, Valerian drops, passion flower and black cherry.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: Ear ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR PAIN (Ear ache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.     On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced EAR PAIN (Ear ache). The patient was treated with IBUPROFEN for Ear ache, at an unspecified dose and frequency. At the time of the report, EAR PAIN (Ear ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medications were not provided.   This case was linked to MOD21-068717, MOD21-068716, MOD21-068620, MOD21-068645, MOD21-068696, MOD21-068713, MOD21-068703, MOD21-068705, MOD21-068707, MOD21-068709, MOD21-068711 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Swollen Eyes; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Swollen Eyes) 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 31-Mar-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) at an unspecified dose. On 01-Apr-2021, the patient experienced EYE SWELLING (Swollen Eyes). At the time of the report, EYE SWELLING (Swollen Eyes) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided. Action taken with mRNA-123 is not applicable.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Appetite disorder, Diarrhoea, Fatigue, Lethargy
Clinical narrative: tired/lethargic; no sense of hunger; severe abdominal cramping; 2 episodes of diarrhea; no nausea straight vomiting; tired/lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (tired/lethargic), APPETITE DISORDER (no sense of hunger), ABDOMINAL PAIN (severe abdominal cramping), DIARRHOEA (2 episodes of diarrhea) and VOMITING (no nausea straight vomiting) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EN6204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history.  The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (LIPITOR), CELECOXIB (CELEXA [CELECOXIB]), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), VITAMIN D [VITAMIN D NOS], CHORIONIC GONADOTROPHIN (PROVIGIL [CHORIONIC GONADOTROPHIN]) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced LETHARGY (tired/lethargic), APPETITE DISORDER (no sense of hunger), ABDOMINAL PAIN (severe abdominal cramping), DIARRHOEA (2 episodes of diarrhea), VOMITING (no nausea straight vomiting) and FATIGUE (tired/lethargic). The patient was treated with FAMOTIDINE (PEPCID AC) ongoing since an unknown date for Diarrhea, at an unspecified dose and frequency. At the time of the report, LETHARGY (tired/lethargic), APPETITE DISORDER (no sense of hunger), ABDOMINAL PAIN (severe abdominal cramping), DIARRHOEA (2 episodes of diarrhea), VOMITING (no nausea straight vomiting) and FATIGUE (tired/lethargic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included pepcid.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: tired/lethargic; no sense of hunger; severe abdominal cramping; 2 episodes of diarrhea; no nausea straight vomiting; tired/lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (tired/lethargic), APPETITE DISORDER (no sense of hunger), ABDOMINAL PAIN (severe abdominal cramping), DIARRHOEA (2 episodes of diarrhea) and VOMITING (no nausea straight vomiting) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EN6204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history.  The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN CALCIUM (LIPITOR), CELECOXIB (CELEXA [CELECOXIB]), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), VITAMIN D [VITAMIN D NOS], CHORIONIC GONADOTROPHIN (PROVIGIL [CHORIONIC GONADOTROPHIN]) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced LETHARGY (tired/lethargic), APPETITE DISORDER (no sense of hunger), ABDOMINAL PAIN (severe abdominal cramping), DIARRHOEA (2 episodes of diarrhea), VOMITING (no nausea straight vomiting) and FATIGUE (tired/lethargic). The patient was treated with FAMOTIDINE (PEPCID AC) ongoing since an unknown date for Diarrhea, at an unspecified dose and frequency. At the time of the report, LETHARGY (tired/lethargic), APPETITE DISORDER (no sense of hunger), ABDOMINAL PAIN (severe abdominal cramping), DIARRHOEA (2 episodes of diarrhea), VOMITING (no nausea straight vomiting) and FATIGUE (tired/lethargic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included pepcid.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) SARS-CoV-2 antibody test positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use information was not provided by reporter  Treatment medication use information was not provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2021: TCR received on 27/Jun/2021 contains No New Information. Patient completely asymptomatic.