chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain, Testicular swelling
Clinical narrative: chills; aching; like a bad flu; his left testicle swollen; his left is painful when you touch it; nausea; he had fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), PYREXIA (he had fever), CHILLS (chills), PAIN (aching) and INFLUENZA LIKE ILLNESS (like a bad flu) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced NAUSEA (nausea), PYREXIA (he had fever), PAIN (aching), INFLUENZA LIKE ILLNESS (like a bad flu), TESTICULAR SWELLING (his left testicle swollen) and TESTICULAR PAIN (his left is painful when you touch it). On an unknown date, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Mar-2021, NAUSEA (nausea), PYREXIA (he had fever), PAIN (aching), INFLUENZA LIKE ILLNESS (like a bad flu) and TESTICULAR SWELLING (his left testicle swollen) outcome was unknown. At the time of the report, CHILLS (chills) and TESTICULAR PAIN (his left is painful when you touch it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        no concomitant medication provided
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: POSITIVE COVID TEST; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (POSITIVE COVID TEST) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced COVID-19 (POSITIVE COVID TEST). At the time of the report, COVID-19 (POSITIVE COVID TEST) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relavent concomitant medications were reported.  Upon internal review on 21-May-2021, the age was corrected to unknown.
Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergies increased; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergies increased) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Anosmia, Ageusia and Allergy. Concomitant products included ALBUTEROL SULFATE and FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced HYPERSENSITIVITY (allergies increased). At the time of the report, HYPERSENSITIVITY (allergies increased) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were inhalers.   This case was linked to MOD-2021-226696 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Eructation, Flatulence, Headache, Nausea
Clinical narrative: Nausea; Gassy; Burping a lot; Metallic taste in the mouth; Mild headaches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), FLATULENCE (Gassy), ERUCTATION (Burping a lot), DYSGEUSIA (Metallic taste in the mouth) and HEADACHE (Mild headaches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced NAUSEA (Nausea), FLATULENCE (Gassy), ERUCTATION (Burping a lot), DYSGEUSIA (Metallic taste in the mouth) and HEADACHE (Mild headaches). At the time of the report, NAUSEA (Nausea), FLATULENCE (Gassy), ERUCTATION (Burping a lot), DYSGEUSIA (Metallic taste in the mouth) and HEADACHE (Mild headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were  provided by Reporter No treatment medicine were  provided by Reporter
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: left arm hurts, can barely move her arm; feeling nausea; headache; little tired; actually threw up; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurts, can barely move her arm), NAUSEA (feeling nausea), HEADACHE (headache), FATIGUE (little tired) and VOMITING (actually threw up) in a 23-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 08-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 PAIN IN EXTREMITY (left arm hurts, can barely move her arm), NAUSEA (feeling nausea), HEADACHE (headache), FATIGUE (little tired), VOMITING (actually threw up) and PYREXIA (low grade fever). At the time of the report, PAIN IN EXTREMITY (left arm hurts, can barely move her arm), NAUSEA (feeling nausea), HEADACHE (headache), FATIGUE (little tired), VOMITING (actually threw up) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug included birth control. Treatment was not reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: left arm hurts, can barely move her arm; feeling nausea; headache; little tired; actually threw up; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurts, can barely move her arm), NAUSEA (feeling nausea), HEADACHE (headache), FATIGUE (little tired) and VOMITING (actually threw up) in a 23-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 08-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 PAIN IN EXTREMITY (left arm hurts, can barely move her arm), NAUSEA (feeling nausea), HEADACHE (headache), FATIGUE (little tired), VOMITING (actually threw up) and PYREXIA (low grade fever). At the time of the report, PAIN IN EXTREMITY (left arm hurts, can barely move her arm), NAUSEA (feeling nausea), HEADACHE (headache), FATIGUE (little tired), VOMITING (actually threw up) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug included birth control. Treatment was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very very sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 029L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS and CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Very very sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Very very sore arm) outcome was unknown.            Concomitant Medications also includes Something for neck pain.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia
Clinical narrative: felt crappy; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt crappy), CHILLS (chills) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TOFACITINIB CITRATE (XELJANZ) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt crappy), CHILLS (chills) and PYREXIA (fever). At the time of the report, FEELING ABNORMAL (felt crappy), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Arm Rash referred to it as "Covid Arm"; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Arm Rash referred to it as "Covid Arm") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Arm Rash referred to it as "Covid Arm"). At the time of the report, RASH (Arm Rash referred to it as "Covid Arm") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was reported.  treatment to the events not provided.  Patient  also mentioned that she had a arm rash 9 days after the vaccine.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot at the injection site; Hardness at the injection site; Swelling at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment medications was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema, Pruritus
Clinical narrative: severe itch on chest and back; lymphedema flare up of leg; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (lymphedema flare up of leg) and PRURITUS (severe itch on chest and back) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Lymphedema.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 12-Feb-2021, the patient experienced LYMPHOEDEMA (lymphedema flare up of leg). On 05-Mar-2021, the patient experienced PRURITUS (severe itch on chest and back). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of UNK dosage form; HYDROCORTISONE (SARNA HC) for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form. On 03-Mar-2021, LYMPHOEDEMA (lymphedema flare up of leg) had resolved. At the time of the report, PRURITUS (severe itch on chest and back) had not resolved.            No concomitant medications reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itchiness at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchiness at injection site) and INJECTION SITE RASH (Rash at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INJECTION SITE PRURITUS (Itchiness at injection site) and INJECTION SITE RASH (Rash at injection site). At the time of the report, INJECTION SITE PRURITUS (Itchiness at injection site) and INJECTION SITE RASH (Rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included coconut oil.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: shoulder, neck along collarbone (more so on the left side) are swollen; fatigue; shoulder and neck tender; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), SWELLING (shoulder, neck along collarbone (more so on the left side) are swollen), CHILLS (chills), FATIGUE (fatigue) and PAIN (shoulder and neck tender) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 08-Mar-2021, the patient experienced FATIGUE (fatigue) and PAIN (shoulder and neck tender). On 09-Mar-2021, the patient experienced SWELLING (shoulder, neck along collarbone (more so on the left side) are swollen). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and PAIN (shoulder and neck tender) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 102 (High) 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include a "water pill".
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: shoulder, neck along collarbone (more so on the left side) are swollen; fatigue; shoulder and neck tender; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), SWELLING (shoulder, neck along collarbone (more so on the left side) are swollen), CHILLS (chills), FATIGUE (fatigue) and PAIN (shoulder and neck tender) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 08-Mar-2021, the patient experienced FATIGUE (fatigue) and PAIN (shoulder and neck tender). On 09-Mar-2021, the patient experienced SWELLING (shoulder, neck along collarbone (more so on the left side) are swollen). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and PAIN (shoulder and neck tender) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 102 (High) 102F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include a "water pill".
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling hot, Inflammation, Peripheral swelling
Clinical narrative: swollen arm; redness; Inflammation; arm was hot to touch; Bump; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (redness), INFLAMMATION (Inflammation) and FEELING HOT (arm was hot to touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) 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 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (Extreme fatigue). On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ERYTHEMA (redness), INFLAMMATION (Inflammation), FEELING HOT (arm was hot to touch) and SKIN MASS (Bump). At the time of the report, FATIGUE (Extreme fatigue), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (redness), INFLAMMATION (Inflammation), FEELING HOT (arm was hot to touch) and SKIN MASS (Bump) outcome was unknown. Not Provided          No concomitant medications or treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: swollen arm; redness; Inflammation; arm was hot to touch; Bump; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme fatigue), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (redness), INFLAMMATION (Inflammation) and FEELING HOT (arm was hot to touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) 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 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (Extreme fatigue). On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ERYTHEMA (redness), INFLAMMATION (Inflammation), FEELING HOT (arm was hot to touch) and SKIN MASS (Bump). At the time of the report, FATIGUE (Extreme fatigue), PERIPHERAL SWELLING (swollen arm), ERYTHEMA (redness), INFLAMMATION (Inflammation), FEELING HOT (arm was hot to touch) and SKIN MASS (Bump) outcome was unknown. Not Provided          No concomitant medications or treatment details reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and MYALGIA (Muscle ache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-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 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and MYALGIA (Muscle ache). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and MYALGIA (Muscle ache) had not resolved.            No treatment information was provided.  No relevant concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast mass, Fatigue, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Lumps on her chest; Pain moved under her arm; Fever of 101.1 degrees F; Tired; Sleepy; Arm was painful; Extreme pain on her upper back; Back was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.1 degrees F), FATIGUE (Tired), SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Arm was painful) and BACK PAIN (Extreme pain on her upper back) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN and FAMOTIDINE for an unknown indication.   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 2 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever of 101.1 degrees F), FATIGUE (Tired), SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Arm was painful), BACK PAIN (Extreme pain on her upper back), MUSCULOSKELETAL DISCOMFORT (Back was hurting) and PAIN IN EXTREMITY (Pain moved under her arm). On 06-Mar-2021, the patient experienced BREAST MASS (Lumps on her chest). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. On 08-Mar-2021, PYREXIA (Fever of 101.1 degrees F) had resolved. At the time of the report, FATIGUE (Tired), SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Arm was painful), BREAST MASS (Lumps on her chest) and PAIN IN EXTREMITY (Pain moved under her arm) outcome was unknown and BACK PAIN (Extreme pain on her upper back) and MUSCULOSKELETAL DISCOMFORT (Back was hurting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Pyrexia: 101.1 Degree F..
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Lumps on her chest; Pain moved under her arm; Fever of 101.1 degrees F; Tired; Sleepy; Arm was painful; Extreme pain on her upper back; Back was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101.1 degrees F), FATIGUE (Tired), SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Arm was painful) and BACK PAIN (Extreme pain on her upper back) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN and FAMOTIDINE for an unknown indication.   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 2 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever of 101.1 degrees F), FATIGUE (Tired), SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Arm was painful), BACK PAIN (Extreme pain on her upper back), MUSCULOSKELETAL DISCOMFORT (Back was hurting) and PAIN IN EXTREMITY (Pain moved under her arm). On 06-Mar-2021, the patient experienced BREAST MASS (Lumps on her chest). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. On 08-Mar-2021, PYREXIA (Fever of 101.1 degrees F) had resolved. At the time of the report, FATIGUE (Tired), SOMNOLENCE (Sleepy), PAIN IN EXTREMITY (Arm was painful), BREAST MASS (Lumps on her chest) and PAIN IN EXTREMITY (Pain moved under her arm) outcome was unknown and BACK PAIN (Extreme pain on her upper back) and MUSCULOSKELETAL DISCOMFORT (Back was hurting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Pyrexia: 101.1 Degree F..
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase decreased, Alanine aminotransferase increased, Aspartate aminotransferase decreased, Aspartate aminotransferase increased
Clinical narrative: ALT and AST went down; ALT and AST went down; ALT went up; AST went up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALANINE AMINOTRANSFERASE INCREASED (ALT went up), ASPARTATE AMINOTRANSFERASE INCREASED (AST went up), ALANINE AMINOTRANSFERASE DECREASED (ALT and AST went down) and ASPARTATE AMINOTRANSFERASE DECREASED (ALT and AST went down) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Thyroid disorder, AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]), SIMVASTATIN, FERROUS SULFATE, VITAMINS NOS (MULTIVITAMINS ) and PROBIOTICS NOS for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ALANINE AMINOTRANSFERASE INCREASED (ALT went up) and ASPARTATE AMINOTRANSFERASE INCREASED (AST went up). On 02-Mar-2021, the patient experienced ALANINE AMINOTRANSFERASE DECREASED (ALT and AST went down) and ASPARTATE AMINOTRANSFERASE DECREASED (ALT and AST went down). At the time of the report, ALANINE AMINOTRANSFERASE INCREASED (ALT went up), ASPARTATE AMINOTRANSFERASE INCREASED (AST went up), ALANINE AMINOTRANSFERASE DECREASED (ALT and AST went down) and ASPARTATE AMINOTRANSFERASE DECREASED (ALT and AST went down) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash
Clinical narrative: Terrible rash on the hands; Very intense itching; Hands red; Hot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Terrible rash on the hands), PRURITUS (Very intense itching), ERYTHEMA (Hands red) and FEELING HOT (Hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Terrible rash on the hands), PRURITUS (Very intense itching), ERYTHEMA (Hands red) and FEELING HOT (Hot). At the time of the report, RASH (Terrible rash on the hands), ERYTHEMA (Hands red) and FEELING HOT (Hot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching at injection site.; The injection site area "was hard, swollen; The injection site area "was hard, swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site.), VACCINATION SITE INDURATION (The injection site area "was hard, swollen) and VACCINATION SITE SWELLING (The injection site area "was hard, swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at injection site.), VACCINATION SITE INDURATION (The injection site area "was hard, swollen) and VACCINATION SITE SWELLING (The injection site area "was hard, swollen). At the time of the report, VACCINATION SITE PRURITUS (itching at injection site.), VACCINATION SITE INDURATION (The injection site area "was hard, swollen) and VACCINATION SITE SWELLING (The injection site area "was hard, swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site induration, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: knot in the arm of the injection/knot is hard, hot to the touch and painful; knot in the arm of the injection/knot is hard, hot to the touch and painful; knot in the arm of the injection/knot is hard, hot to the touch and painful; knot in the arm of the injection/knot is hard, hot to the touch and painful; Right arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE MASS (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE INDURATION (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE PAIN (knot in the arm of the injection/knot is hard, hot to the touch and painful) and PAIN (Right arm pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Right arm pain). On 06-Mar-2021, the patient experienced VACCINATION SITE WARMTH (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE MASS (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE INDURATION (knot in the arm of the injection/knot is hard, hot to the touch and painful) and VACCINATION SITE PAIN (knot in the arm of the injection/knot is hard, hot to the touch and painful). On 08-Feb-2021, PAIN (Right arm pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE MASS (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE INDURATION (knot in the arm of the injection/knot is hard, hot to the touch and painful) and VACCINATION SITE PAIN (knot in the arm of the injection/knot is hard, hot to the touch and painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took one medical marijuana gummy.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Significant FU=event added
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Hyperhidrosis, Influenza like illness, Pain in extremity
Clinical narrative: pain in the arm; sweating all day; stomach ache; flu like symptoms; dizzy; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), HYPERHIDROSIS (sweating all day), ABDOMINAL PAIN UPPER (stomach ache), INFLUENZA LIKE ILLNESS (flu like symptoms) and DIZZINESS (dizzy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), HYPERHIDROSIS (sweating all day), ABDOMINAL PAIN UPPER (stomach ache), INFLUENZA LIKE ILLNESS (flu like symptoms) and DIZZINESS (dizzy). At the time of the report, PAIN IN EXTREMITY (pain in the arm), HYPERHIDROSIS (sweating all day), ABDOMINAL PAIN UPPER (stomach ache), INFLUENZA LIKE ILLNESS (flu like symptoms) and DIZZINESS (dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Fatigue, Feeling abnormal, Limb discomfort, Myalgia
Clinical narrative: sore arm; she was tired for a week; scaling on her face; droopy eyes; droopy eyes and itchy; She said it looked like facial psoriasis; felt weird; it hurt going into my arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), FATIGUE (she was tired for a week), SKIN INJURY (scaling on her face), OCULAR DISCOMFORT (droopy eyes) and EYE PRURITUS (droopy eyes and itchy) in a 71-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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 04-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (felt weird) and LIMB DISCOMFORT (it hurt going into my arm). On an unknown date, the patient experienced MYALGIA (sore arm), FATIGUE (she was tired for a week), SKIN INJURY (scaling on her face), OCULAR DISCOMFORT (droopy eyes), EYE PRURITUS (droopy eyes and itchy) and PSORIASIS (She said it looked like facial psoriasis). The patient was treated with PIMECROLIMUS (ELIDEL) (topical) at an unspecified dose and frequency. At the time of the report, MYALGIA (sore arm), FATIGUE (she was tired for a week), SKIN INJURY (scaling on her face), OCULAR DISCOMFORT (droopy eyes), EYE PRURITUS (droopy eyes and itchy), PSORIASIS (She said it looked like facial psoriasis), FEELING ABNORMAL (felt weird) and LIMB DISCOMFORT (it hurt going into my arm) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Psoriasis, Skin injury
Clinical narrative: sore arm; she was tired for a week; scaling on her face; droopy eyes; droopy eyes and itchy; She said it looked like facial psoriasis; felt weird; it hurt going into my arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), FATIGUE (she was tired for a week), SKIN INJURY (scaling on her face), OCULAR DISCOMFORT (droopy eyes) and EYE PRURITUS (droopy eyes and itchy) in a 71-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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 04-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (felt weird) and LIMB DISCOMFORT (it hurt going into my arm). On an unknown date, the patient experienced MYALGIA (sore arm), FATIGUE (she was tired for a week), SKIN INJURY (scaling on her face), OCULAR DISCOMFORT (droopy eyes), EYE PRURITUS (droopy eyes and itchy) and PSORIASIS (She said it looked like facial psoriasis). The patient was treated with PIMECROLIMUS (ELIDEL) (topical) at an unspecified dose and frequency. At the time of the report, MYALGIA (sore arm), FATIGUE (she was tired for a week), SKIN INJURY (scaling on her face), OCULAR DISCOMFORT (droopy eyes), EYE PRURITUS (droopy eyes and itchy), PSORIASIS (She said it looked like facial psoriasis), FEELING ABNORMAL (felt weird) and LIMB DISCOMFORT (it hurt going into my arm) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Somnolence
Clinical narrative: ery sleepy after receiving the vaccine.; redness in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness in the injection arm) and SOMNOLENCE (ery sleepy after receiving the vaccine.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (redness in the injection arm). On an unknown date, the patient experienced SOMNOLENCE (ery sleepy after receiving the vaccine.). At the time of the report, INJECTION SITE ERYTHEMA (redness in the injection arm) and SOMNOLENCE (ery sleepy after receiving the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were taken. No treatment drugs were taken.   Reporter did not allow further contact
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: her arm was really sore for 2 and a half days; vomit for two mornings; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (her arm was really sore for 2 and a half days) and VOMITING (vomit for two mornings) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (her arm was really sore for 2 and a half days) and VOMITING (vomit for two mornings). On 07-Mar-2021, VACCINATION SITE PAIN (her arm was really sore for 2 and a half days) and VOMITING (vomit for two mornings) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (Fatigue). On 04-Feb-2021, FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant drugs were reported. No treatment medications were reported.   This case was linked to MOD-2021-067099 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red) and PRURITUS (itchy) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced ERYTHEMA (red) and PRURITUS (itchy). At the time of the report, ERYTHEMA (red) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Irritability, Myalgia
Clinical narrative: cold; dizziness; extreme fatigue; muscle aches and pains; severe headaches; irritable; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (irritable), NASOPHARYNGITIS (cold), DIZZINESS (dizziness), FATIGUE (extreme fatigue) and MYALGIA (muscle aches and pains) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced IRRITABILITY (irritable), FATIGUE (extreme fatigue), MYALGIA (muscle aches and pains) and HEADACHE (severe headaches). On 01-Mar-2021, the patient experienced NASOPHARYNGITIS (cold) and DIZZINESS (dizziness). At the time of the report, IRRITABILITY (irritable), NASOPHARYNGITIS (cold), DIZZINESS (dizziness), FATIGUE (extreme fatigue), MYALGIA (muscle aches and pains) and HEADACHE (severe headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   This case was linked to MOD21-031737, MOD21-036106 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; dizziness; extreme fatigue; muscle aches and pains; severe headaches; irritable; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (irritable), NASOPHARYNGITIS (cold), DIZZINESS (dizziness), FATIGUE (extreme fatigue) and MYALGIA (muscle aches and pains) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced IRRITABILITY (irritable), FATIGUE (extreme fatigue), MYALGIA (muscle aches and pains) and HEADACHE (severe headaches). On 01-Mar-2021, the patient experienced NASOPHARYNGITIS (cold) and DIZZINESS (dizziness). At the time of the report, IRRITABILITY (irritable), NASOPHARYNGITIS (cold), DIZZINESS (dizziness), FATIGUE (extreme fatigue), MYALGIA (muscle aches and pains) and HEADACHE (severe headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   This case was linked to MOD21-031737, MOD21-036106 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pyrexia, Somnolence, Vomiting
Clinical narrative: not feeling good at all; staying in bed; throwing up; aching,pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling good at all), SOMNOLENCE (staying in bed), VOMITING (throwing up), MYALGIA (aching,pain) and PYREXIA (fever) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (not feeling good at all), SOMNOLENCE (staying in bed), VOMITING (throwing up), MYALGIA (aching,pain) and PYREXIA (fever). The patient was treated with ACETAMINOPHEN at a dose of UNK, q8h. At the time of the report, FEELING ABNORMAL (not feeling good at all), SOMNOLENCE (staying in bed), VOMITING (throwing up), MYALGIA (aching,pain) and PYREXIA (fever) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 and contains significant information. Updated treatment information