chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Feeling abnormal, Limb discomfort
Clinical narrative: Chills; FEELS AWFUL; Nausea; ARM PAIN; TIREDNESS; red puffy arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red puffy arm), NAUSEA (Nausea), LIMB DISCOMFORT (ARM PAIN), FATIGUE (TIREDNESS) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 031A21A) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (red puffy arm). On 10-Mar-2021, the patient experienced NAUSEA (Nausea), LIMB DISCOMFORT (ARM PAIN) and FATIGUE (TIREDNESS). On 28-Mar-2021, the patient experienced CHILLS (Chills) and FEELING ABNORMAL (FEELS AWFUL). On 12-Mar-2021, NAUSEA (Nausea), LIMB DISCOMFORT (ARM PAIN) and FATIGUE (TIREDNESS) had resolved. At the time of the report, ERYTHEMA (red puffy arm), CHILLS (Chills) and FEELING ABNORMAL (FEELS AWFUL) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       NO treatment or concomitant medication reported in the source document.   This case was linked to MOD-2021-061127 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Chills; FEELS AWFUL; Nausea; ARM PAIN; TIREDNESS; red puffy arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red puffy arm), NAUSEA (Nausea), LIMB DISCOMFORT (ARM PAIN), FATIGUE (TIREDNESS) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 031A21A) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (red puffy arm). On 10-Mar-2021, the patient experienced NAUSEA (Nausea), LIMB DISCOMFORT (ARM PAIN) and FATIGUE (TIREDNESS). On 28-Mar-2021, the patient experienced CHILLS (Chills) and FEELING ABNORMAL (FEELS AWFUL). On 12-Mar-2021, NAUSEA (Nausea), LIMB DISCOMFORT (ARM PAIN) and FATIGUE (TIREDNESS) had resolved. At the time of the report, ERYTHEMA (red puffy arm), CHILLS (Chills) and FEELING ABNORMAL (FEELS AWFUL) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       NO treatment or concomitant medication reported in the source document.   This case was linked to MOD-2021-061127 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and RASH (Rash) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced PRURITUS (Itchy). At the time of the report, PRURITUS (Itchy) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Sore Arm; Lethargy; Headache; Body temperature increased; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), LETHARGY (Lethargy), HEADACHE (Headache) and PYREXIA (Body temperature increased) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS (DAILY VITAMINS), METOPROLOL, SIMVASTATIN, OLMESARTAN and WARFARIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), LETHARGY (Lethargy), HEADACHE (Headache) and PYREXIA (Body temperature increased). At the time of the report, PAIN IN EXTREMITY (Sore Arm), LETHARGY (Lethargy), HEADACHE (Headache) and PYREXIA (Body temperature increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: unknown (High) Patient experienced elevated temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.  Patient gave consent to safety for Follow-up.   This case was linked to MOD-2021-061119, MOD-2021-061119 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Musculoskeletal chest pain, Pain, Pain in extremity, Swelling
Clinical narrative: weird pain on side of her body near her ribs; pain is localized near armpit and side of breast; pain in both of her arms; radiating; hurts when you touch it; body is more swollen in general; gained a bit of weight; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (weird pain on side of her body near her ribs), BREAST PAIN (pain is localized near armpit and side of breast), PAIN IN EXTREMITY (pain in both of her arms), PAIN (radiating) and PAIN (hurts when you touch it) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A030A21A012A21A) 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 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (weird pain on side of her body near her ribs), BREAST PAIN (pain is localized near armpit and side of breast), PAIN IN EXTREMITY (pain in both of her arms), PAIN (radiating), PAIN (hurts when you touch it), SWELLING (body is more swollen in general) and WEIGHT INCREASED (gained a bit of weight). At the time of the report, MUSCULOSKELETAL CHEST PAIN (weird pain on side of her body near her ribs), BREAST PAIN (pain is localized near armpit and side of breast), PAIN IN EXTREMITY (pain in both of her arms), PAIN (radiating), PAIN (hurts when you touch it), SWELLING (body is more swollen in general) and WEIGHT INCREASED (gained a bit of weight) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: weird pain on side of her body near her ribs; pain is localized near armpit and side of breast; pain in both of her arms; radiating; hurts when you touch it; body is more swollen in general; gained a bit of weight; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (weird pain on side of her body near her ribs), BREAST PAIN (pain is localized near armpit and side of breast), PAIN IN EXTREMITY (pain in both of her arms), PAIN (radiating) and PAIN (hurts when you touch it) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A030A21A012A21A) 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 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (weird pain on side of her body near her ribs), BREAST PAIN (pain is localized near armpit and side of breast), PAIN IN EXTREMITY (pain in both of her arms), PAIN (radiating), PAIN (hurts when you touch it), SWELLING (body is more swollen in general) and WEIGHT INCREASED (gained a bit of weight). At the time of the report, MUSCULOSKELETAL CHEST PAIN (weird pain on side of her body near her ribs), BREAST PAIN (pain is localized near armpit and side of breast), PAIN IN EXTREMITY (pain in both of her arms), PAIN (radiating), PAIN (hurts when you touch it), SWELLING (body is more swollen in general) and WEIGHT INCREASED (gained a bit of weight) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain
Clinical narrative: redness; little achiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness) and PAIN (little achiness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included AMLODIPINE and ATORVASTATIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced ERYTHEMA (redness) and PAIN (little achiness). At the time of the report, ERYTHEMA (redness) and PAIN (little achiness) outcome was unknown.            No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to MOD-2021-066945, MOD-2021-066945 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching all over the body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (itching all over the body). On 27-Mar-2021, PRURITUS (itching all over the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pain in extremity, Paraesthesia
Clinical narrative: Sore left arm; Felt as if vaccine went from shoulder through neck and to lips; Swelling of lower lip; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Felt as if vaccine went from shoulder through neck and to lips), LIP SWELLING (Swelling of lower lip) and PAIN IN EXTREMITY (Sore left arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Medical History is not provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) and PREGABALIN (LYRICA) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PARAESTHESIA (Felt as if vaccine went from shoulder through neck and to lips) and LIP SWELLING (Swelling of lower lip). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm). At the time of the report, PARAESTHESIA (Felt as if vaccine went from shoulder through neck and to lips), LIP SWELLING (Swelling of lower lip) and PAIN IN EXTREMITY (Sore left arm) 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound abdomen
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Aug-2020 and the estimated date of delivery was 06-Jun-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2020, Pregnancy test: positive (Positive) positive. In March 2021, Blood glucose: normal (normal) normal. In March 2021, Ultrasound abdomen: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Pre-Natal Vitamins, oral, QD since 2016. Treatment information was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: hot; rash on injection site; red; sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot), INJECTION SITE RASH (rash on injection site), ERYTHEMA (red) and INJECTION SITE PAIN (sore) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and O11M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (hot), INJECTION SITE RASH (rash on injection site), ERYTHEMA (red) and INJECTION SITE PAIN (sore). At the time of the report, INJECTION SITE WARMTH (hot), INJECTION SITE RASH (rash on injection site), ERYTHEMA (red) and INJECTION SITE PAIN (sore) had not resolved.            Action taken with mRNA 1273 in response to event was consider to be non applicable.  No concomitant and no treatment medications were provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: feels awful; chills; Arm pain; Nausea; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), FEELING ABNORMAL (feels awful), NAUSEA (Nausea), FATIGUE (tiredness) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), NAUSEA (Nausea) and FATIGUE (tiredness). On 28-Mar-2021, the patient experienced FEELING ABNORMAL (feels awful) and CHILLS (chills). On 12-Mar-2021, PAIN IN EXTREMITY (Arm pain), NAUSEA (Nausea) and FATIGUE (tiredness) had resolved. At the time of the report, FEELING ABNORMAL (feels awful) and CHILLS (chills) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event were not provided. Concomitant medications were not provided. No laboratory investigations were provided. The Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-061117 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Caller received 1st dose but not 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller received 1st dose but not 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller received 1st dose but not 2nd dose). On 18-Jan-2021, PRODUCT DOSE OMISSION ISSUE (Caller received 1st dose but not 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.  This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information was received on 18-May-2021, No new information was provided.; Sender's Comments: This report refers to a case of product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersensitivity, Pain, Peripheral swelling
Clinical narrative: itchy; rash is going down in her arm; headache; tiredness; little fever; sore; hardness; warm to touch; covid arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (covid arm), PAIN (sore), PERIPHERAL SWELLING (hardness), VACCINATION SITE WARMTH (warm to touch) and PRURITUS (itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Feb-2021, the patient experienced HYPERSENSITIVITY (covid arm). On 08-Mar-2021, the patient experienced PAIN (sore), PERIPHERAL SWELLING (hardness), VACCINATION SITE WARMTH (warm to touch), RASH (rash is going down in her arm), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (little fever). On 11-Mar-2021, the patient experienced PRURITUS (itchy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (covid arm), PAIN (sore), PERIPHERAL SWELLING (hardness), VACCINATION SITE WARMTH (warm to touch), PRURITUS (itchy), RASH (rash is going down in her arm), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (little fever) outcome was unknown.            Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Vaccination site warmth
Clinical narrative: itchy; rash is going down in her arm; headache; tiredness; little fever; sore; hardness; warm to touch; covid arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (covid arm), PAIN (sore), PERIPHERAL SWELLING (hardness), VACCINATION SITE WARMTH (warm to touch) and PRURITUS (itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Feb-2021, the patient experienced HYPERSENSITIVITY (covid arm). On 08-Mar-2021, the patient experienced PAIN (sore), PERIPHERAL SWELLING (hardness), VACCINATION SITE WARMTH (warm to touch), RASH (rash is going down in her arm), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (little fever). On 11-Mar-2021, the patient experienced PRURITUS (itchy). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (covid arm), PAIN (sore), PERIPHERAL SWELLING (hardness), VACCINATION SITE WARMTH (warm to touch), PRURITUS (itchy), RASH (rash is going down in her arm), HEADACHE (headache), FATIGUE (tiredness) and PYREXIA (little fever) outcome was unknown.            Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Myalgia, Pyrexia
Clinical narrative: hypersomnia; Fever; Bodyaches; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (hypersomnia), PYREXIA (Fever), MYALGIA (Bodyaches) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus.   On 11-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) 1 dosage form. On 11-Feb-2021, the patient experienced HYPERSOMNIA (hypersomnia), PYREXIA (Fever), MYALGIA (Bodyaches) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) on 11-Mar-2021 for Fever, at an unspecified dose and frequency. On 11-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, HYPERSOMNIA (hypersomnia), MYALGIA (Bodyaches) and FATIGUE (Tiredness) outcome was unknown.            The patient associated  symptoms with immunocompromised state of Lupus. Concomitant medications were not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Feeling abnormal, Lymphadenopathy
Clinical narrative: mild cough; lymph nodes in throat were swollen; achy; fatigue; joint pain; felt horrible; sore throat; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt horrible), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (nasal congestion), COUGH (mild cough) and LYMPHADENOPATHY (lymph nodes in throat were swollen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (felt horrible), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (nasal congestion), LYMPHADENOPATHY (lymph nodes in throat were swollen), MYALGIA (achy), FATIGUE (fatigue) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced COUGH (mild cough). At the time of the report, FEELING ABNORMAL (felt horrible), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (nasal congestion), COUGH (mild cough), LYMPHADENOPATHY (lymph nodes in throat were swollen), MYALGIA (achy), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided No concomitant medication were provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: mild cough; lymph nodes in throat were swollen; achy; fatigue; joint pain; felt horrible; sore throat; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt horrible), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (nasal congestion), COUGH (mild cough) and LYMPHADENOPATHY (lymph nodes in throat were swollen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (felt horrible), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (nasal congestion), LYMPHADENOPATHY (lymph nodes in throat were swollen), MYALGIA (achy), FATIGUE (fatigue) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced COUGH (mild cough). At the time of the report, FEELING ABNORMAL (felt horrible), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (nasal congestion), COUGH (mild cough), LYMPHADENOPATHY (lymph nodes in throat were swollen), MYALGIA (achy), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided No concomitant medication were provided.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: sore arm; down arm and backside; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (down arm and backside) and INSOMNIA (can't sleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (down arm and backside) and INSOMNIA (can't sleep). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (down arm and backside) and INSOMNIA (can't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Product dose omission issue, SARS-CoV-2 carrier, SARS-CoV-2 test
Clinical narrative: Missed second dose time window; Positive COVID Test; began to feel tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose time window), SARS-COV-2 CARRIER (Positive COVID Test) and FATIGUE (began to feel tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), ETODOLAC, OMEPRAZOLE, METFORMIN, INSULIN GLARGINE (LANTUS), LEVOTHYROXINE, CLARITHROMYCIN (CLAVIX), ATENOLOL, ISOSORBIDE MONONITRATE and LIRAGLUTIDE (VICTOZA) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced SARS-COV-2 CARRIER (Positive COVID Test) and FATIGUE (began to feel tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose time window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose time window) had resolved and SARS-COV-2 CARRIER (Positive COVID Test) and FATIGUE (began to feel tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, SARS-CoV-2 test: positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Treatment for Covid-19 included, intravenous (IV) Bamlanivimab. No medical history was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, SARS-Cov2 carrier and fatigue, a causal relationship cannot be excluded.  This report also refers to a case of product dose omission issue for mRNA-1273, lot # 031L20A.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019BA1A) for COVID-19 vaccination.     Concomitant products included METFORMIN, CARVEDILOL, HYDRALAZINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ASTHENIA (Weakness). At the time of the report, ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: experienced gastrointestinal issues, diarrhea; experienced gastrointestinal issues, diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (experienced gastrointestinal issues, diarrhea) and DIARRHOEA (experienced gastrointestinal issues, diarrhea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (experienced gastrointestinal issues, diarrhea) and DIARRHOEA (experienced gastrointestinal issues, diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (experienced gastrointestinal issues, diarrhea) and DIARRHOEA (experienced gastrointestinal issues, diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received as non-significant information where consent to follow-up is denied.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Muscle spasms, Pain, Pyrexia
Clinical narrative: Cramp in my right leg; Stomach was hurting; Vomiting; Couldn't stay awake; Hurt all over/ aching; Head hurt; Fever of 101.7 degrees F; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomach was hurting), SOMNOLENCE (Couldn't stay awake), MUSCLE SPASMS (Cramp in my right leg) and PAIN (Hurt all over/ aching) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Shaking). On 05-Mar-2021, the patient experienced SOMNOLENCE (Couldn't stay awake), PAIN (Hurt all over/ aching), HEADACHE (Head hurt) and PYREXIA (Fever of 101.7 degrees F). On 06-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach was hurting), MUSCLE SPASMS (Cramp in my right leg) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 06-Mar-2021, TREMOR (Shaking) and HEADACHE (Head hurt) had resolved. On 08-Mar-2021, PYREXIA (Fever of 101.7 degrees F) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach was hurting), SOMNOLENCE (Couldn't stay awake), MUSCLE SPASMS (Cramp in my right leg) and VOMITING (Vomiting) outcome was unknown and PAIN (Hurt all over/ aching) had resolved.            Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-060417, MOD-2021-065797 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received on 01-Jun-2021 contains non-significant information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tremor, Vomiting
Clinical narrative: Cramp in my right leg; Stomach was hurting; Vomiting; Couldn't stay awake; Hurt all over/ aching; Head hurt; Fever of 101.7 degrees F; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomach was hurting), SOMNOLENCE (Couldn't stay awake), MUSCLE SPASMS (Cramp in my right leg) and PAIN (Hurt all over/ aching) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Shaking). On 05-Mar-2021, the patient experienced SOMNOLENCE (Couldn't stay awake), PAIN (Hurt all over/ aching), HEADACHE (Head hurt) and PYREXIA (Fever of 101.7 degrees F). On 06-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach was hurting), MUSCLE SPASMS (Cramp in my right leg) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 06-Mar-2021, TREMOR (Shaking) and HEADACHE (Head hurt) had resolved. On 08-Mar-2021, PYREXIA (Fever of 101.7 degrees F) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach was hurting), SOMNOLENCE (Couldn't stay awake), MUSCLE SPASMS (Cramp in my right leg) and VOMITING (Vomiting) outcome was unknown and PAIN (Hurt all over/ aching) had resolved.            Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-060417, MOD-2021-065797 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received on 01-Jun-2021 contains non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Side effects after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Side effects after vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Side effects after vaccine). At the time of the report, VACCINATION SITE REACTION (Side effects after vaccine) outcome was unknown. Not Provided          No concomitant medications were provided. No treatment details were provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-054743 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Somnolence
Clinical narrative: not feeling great; sleepy; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling great), SOMNOLENCE (sleepy), HEADACHE (headache) and FATIGUE (tired) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 FEELING ABNORMAL (not feeling great), SOMNOLENCE (sleepy), HEADACHE (headache) and FATIGUE (tired). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 27-Mar-2021, FEELING ABNORMAL (not feeling great), SOMNOLENCE (sleepy), HEADACHE (headache) and FATIGUE (tired) had resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  No concomitant medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, Paraesthesia, Pyrexia, Sleep deficit
Clinical narrative: lymph nodes were swollen; felt like her nerves were wild; could not sleep; her throat was rough; light fever; throw up bile not food; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (felt like her nerves were wild), SLEEP DEFICIT (could not sleep), OROPHARYNGEAL PAIN (her throat was rough), LYMPHADENOPATHY (lymph nodes were swollen) and VOMITING (throw up bile not food) in a 67-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 19-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) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VOMITING (throw up bile not food). On 20-Feb-2021, the patient experienced PARAESTHESIA (felt like her nerves were wild), SLEEP DEFICIT (could not sleep), OROPHARYNGEAL PAIN (her throat was rough) and PYREXIA (light fever). On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes were swollen). On 21-Feb-2021, PARAESTHESIA (felt like her nerves were wild), SLEEP DEFICIT (could not sleep), OROPHARYNGEAL PAIN (her throat was rough), VOMITING (throw up bile not food) and PYREXIA (light fever) had resolved. At the time of the report, LYMPHADENOPATHY (lymph nodes were swollen) outcome was unknown.            No concomitant medication were reported. No treatment information was provided. The action taken with mRNA-1273 with the events was considered as not applicable   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: fallow up received on 14-may-2021 includes contact information of the reporter was added
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: lymph nodes were swollen; felt like her nerves were wild; could not sleep; her throat was rough; light fever; throw up bile not food; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (felt like her nerves were wild), SLEEP DEFICIT (could not sleep), OROPHARYNGEAL PAIN (her throat was rough), LYMPHADENOPATHY (lymph nodes were swollen) and VOMITING (throw up bile not food) in a 67-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 19-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) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VOMITING (throw up bile not food). On 20-Feb-2021, the patient experienced PARAESTHESIA (felt like her nerves were wild), SLEEP DEFICIT (could not sleep), OROPHARYNGEAL PAIN (her throat was rough) and PYREXIA (light fever). On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes were swollen). On 21-Feb-2021, PARAESTHESIA (felt like her nerves were wild), SLEEP DEFICIT (could not sleep), OROPHARYNGEAL PAIN (her throat was rough), VOMITING (throw up bile not food) and PYREXIA (light fever) had resolved. At the time of the report, LYMPHADENOPATHY (lymph nodes were swollen) outcome was unknown.            No concomitant medication were reported. No treatment information was provided. The action taken with mRNA-1273 with the events was considered as not applicable   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: fallow up received on 14-may-2021 includes contact information of the reporter was added
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizziness; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vaccination site bruising, Vaccination site erythema, Vaccination site pain
Clinical narrative: Bad stomach ache; Bruise below the band aid; Very nauseous; Arm was very painful even when  moved; redness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Bad stomach ache), VACCINATION SITE BRUISING (Bruise below the band aid), NAUSEA (Very nauseous), VACCINATION SITE PAIN (Arm was very painful even when  moved) and VACCINATION SITE ERYTHEMA (redness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Bad stomach ache), VACCINATION SITE BRUISING (Bruise below the band aid), NAUSEA (Very nauseous), VACCINATION SITE PAIN (Arm was very painful even when  moved) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, ABDOMINAL PAIN UPPER (Bad stomach ache), VACCINATION SITE BRUISING (Bruise below the band aid), NAUSEA (Very nauseous), VACCINATION SITE PAIN (Arm was very painful even when  moved) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-066962 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24-MAY-2021 does not contain any new information
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: it's getting a little itchy; a very noticeable rash on his right arm,on his wrists and around the elbow area, a little bit on his left arm, on his leg, on his chest, on his back, it's going all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (it's getting a little itchy) and RASH (a very noticeable rash on his right arm,on his wrists and around the elbow area, a little bit on his left arm, on his leg, on his chest, on his back, it's going all over) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history information was reported.  The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN, APIXABAN (ELIQUIS), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), DIGOXIN and METOPROLOL for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced RASH PRURITIC (it's getting a little itchy) and RASH (a very noticeable rash on his right arm,on his wrists and around the elbow area, a little bit on his left arm, on his leg, on his chest, on his back, it's going all over). At the time of the report, RASH PRURITIC (it's getting a little itchy) and RASH (a very noticeable rash on his right arm,on his wrists and around the elbow area, a little bit on his left arm, on his leg, on his chest, on his back, it's going all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.