chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite
Clinical narrative: weakness; Loss of appetite; This spontaneous case was reported by a pharmacist and describes the occurrence of ASTHENIA (weakness) and DECREASED APPETITE (Loss of appetite) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (weakness) and DECREASED APPETITE (Loss of appetite). At the time of the report, ASTHENIA (weakness) and DECREASED APPETITE (Loss of appetite) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was unknown by the reporter.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: delayed (started on Day 6) pain under armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (delayed (started on Day 6) pain under armpit) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     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) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced AXILLARY PAIN (delayed (started on Day 6) pain under armpit). At the time of the report, AXILLARY PAIN (delayed (started on Day 6) pain under armpit) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes on the injection arm) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on the injection arm). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes on the injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2021: Follow-up received on 16-FEB-2021 and does not contain any new information (NNI). On 28-Apr-2021: Case for 2nd dose created. Contact information updated. The outcome of the event (swollen lymph nodes) changed (from Unknown to Resolved).
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site discolouration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Got a little itchy, pink again; Little raised at injection site; Some pinkness at injection spot, little pink; Arm sore; Can not lift the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), LIMB DISCOMFORT (Can not lift the arm), VACCINATION SITE DISCOLOURATION (Some pinkness at injection spot, little pink), VACCINATION SITE PRURITUS (Got a little itchy, pink again) and VACCINATION SITE SWELLING (Little raised at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M120A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore) and LIMB DISCOMFORT (Can not lift the arm). On 02-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Some pinkness at injection spot, little pink) and VACCINATION SITE SWELLING (Little raised at injection site). On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Got a little itchy, pink again). At the time of the report, PAIN IN EXTREMITY (Arm sore), LIMB DISCOMFORT (Can not lift the arm), VACCINATION SITE DISCOLOURATION (Some pinkness at injection spot, little pink), VACCINATION SITE PRURITUS (Got a little itchy, pink again) and VACCINATION SITE SWELLING (Little raised at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter.  No treatment information provided by the reporter.  The patient stated that she was feeling fine.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI- AE contact information updated
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash
Clinical narrative: injection site itched really bad; a little bit of a rash appeared; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection site itched really bad) and RASH (a little bit of a rash appeared) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included APIXABAN, LISINOPRIL, HYDROCHLOROTHIAZIDE, OMEPRAZOLE and CITRULLINE for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE PRURITUS (injection site itched really bad) and RASH (a little bit of a rash appeared). At the time of the report, INJECTION SITE PRURITUS (injection site itched really bad) and RASH (a little bit of a rash appeared) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate abnormal, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: still feeling a little tingling of the face; not feeling normal; Mouth was tingly; Heart rate was fast; Mouth was numb/Numbness spread to the face and tongue; Numbness spread to the face and tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Mouth was tingly), HEART RATE ABNORMAL (Heart rate was fast), PARAESTHESIA (still feeling a little tingling of the face), HYPOAESTHESIA ORAL (Mouth was numb/Numbness spread to the face and tongue) and HYPOAESTHESIA (Numbness spread to the face and tongue) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Patient was allergic to penicillin (rash).).   On 14-Feb-2021 at 8:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021 at 6:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced HEART RATE ABNORMAL (Heart rate was fast), HYPOAESTHESIA ORAL (Mouth was numb/Numbness spread to the face and tongue) and HYPOAESTHESIA (Numbness spread to the face and tongue). On 14-Feb-2021 at 9:05 PM, the patient experienced PARAESTHESIA ORAL (Mouth was tingly). On 16-Feb-2021, the patient experienced PARAESTHESIA (still feeling a little tingling of the face) and FEELING ABNORMAL (not feeling normal). On 14-Feb-2021, HEART RATE ABNORMAL (Heart rate was fast) had resolved. On 16-Feb-2021, PARAESTHESIA ORAL (Mouth was tingly) had resolved. At the time of the report, PARAESTHESIA (still feeling a little tingling of the face), HYPOAESTHESIA ORAL (Mouth was numb/Numbness spread to the face and tongue), HYPOAESTHESIA (Numbness spread to the face and tongue) and FEELING ABNORMAL (not feeling normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient demographics updated- initial and follow up will be submitted to regulatory authority together
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: still feeling a little tingling of the face; not feeling normal; Mouth was tingly; Heart rate was fast; Mouth was numb/Numbness spread to the face and tongue; Numbness spread to the face and tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Mouth was tingly), HEART RATE ABNORMAL (Heart rate was fast), PARAESTHESIA (still feeling a little tingling of the face), HYPOAESTHESIA ORAL (Mouth was numb/Numbness spread to the face and tongue) and HYPOAESTHESIA (Numbness spread to the face and tongue) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Patient was allergic to penicillin (rash).).   On 14-Feb-2021 at 8:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021 at 6:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced HEART RATE ABNORMAL (Heart rate was fast), HYPOAESTHESIA ORAL (Mouth was numb/Numbness spread to the face and tongue) and HYPOAESTHESIA (Numbness spread to the face and tongue). On 14-Feb-2021 at 9:05 PM, the patient experienced PARAESTHESIA ORAL (Mouth was tingly). On 16-Feb-2021, the patient experienced PARAESTHESIA (still feeling a little tingling of the face) and FEELING ABNORMAL (not feeling normal). On 14-Feb-2021, HEART RATE ABNORMAL (Heart rate was fast) had resolved. On 16-Feb-2021, PARAESTHESIA ORAL (Mouth was tingly) had resolved. At the time of the report, PARAESTHESIA (still feeling a little tingling of the face), HYPOAESTHESIA ORAL (Mouth was numb/Numbness spread to the face and tongue), HYPOAESTHESIA (Numbness spread to the face and tongue) and FEELING ABNORMAL (not feeling normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient demographics updated- initial and follow up will be submitted to regulatory authority together
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site erythema, Vaccination site swelling
Clinical narrative: left arm had swelled up to the size of a credit card; arm is still bruised; injection site redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (left arm had swelled up to the size of a credit card), CONTUSION (arm is still bruised) and VACCINATION SITE ERYTHEMA (injection site redness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE SWELLING (left arm had swelled up to the size of a credit card), CONTUSION (arm is still bruised) and VACCINATION SITE ERYTHEMA (injection site redness). At the time of the report, VACCINATION SITE SWELLING (left arm had swelled up to the size of a credit card), CONTUSION (arm is still bruised) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included steroid injection, Cephalexin, ice.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Red at injection site; Itchy at injection site; Swollen at injection site/ Raised its head up again at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site/ Raised its head up again at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (Swollen at injection site/ Raised its head up again at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) had resolved and VACCINATION SITE SWELLING (Swollen at injection site/ Raised its head up again at the injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported.  Treatment was not provided/ unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dysgeusia, Fatigue, Influenza like illness
Clinical narrative: starting having a funny taste in her mouth; injection site really bruised; really sore like you would get the flu; cough; rash real red; arm itching; felt like sleeping all day; sore all over/ muscle aches; fatigue; fever at 102.0; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough) and RASH ERYTHEMATOUS (rash real red) in a 51-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 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough), RASH ERYTHEMATOUS (rash real red), PRURITUS (arm itching), SOMNOLENCE (felt like sleeping all day), MYALGIA (sore all over/ muscle aches), FATIGUE (fatigue) and PYREXIA (fever at 102.0). At the time of the report, DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough), RASH ERYTHEMATOUS (rash real red), PRURITUS (arm itching), SOMNOLENCE (felt like sleeping all day), MYALGIA (sore all over/ muscle aches), FATIGUE (fatigue) and PYREXIA (fever at 102.0) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 102 (High) units not reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received provided event onset date.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Myalgia, Pruritus, Pyrexia, Rash erythematous
Clinical narrative: starting having a funny taste in her mouth; injection site really bruised; really sore like you would get the flu; cough; rash real red; arm itching; felt like sleeping all day; sore all over/ muscle aches; fatigue; fever at 102.0; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough) and RASH ERYTHEMATOUS (rash real red) in a 51-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 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough), RASH ERYTHEMATOUS (rash real red), PRURITUS (arm itching), SOMNOLENCE (felt like sleeping all day), MYALGIA (sore all over/ muscle aches), FATIGUE (fatigue) and PYREXIA (fever at 102.0). At the time of the report, DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough), RASH ERYTHEMATOUS (rash real red), PRURITUS (arm itching), SOMNOLENCE (felt like sleeping all day), MYALGIA (sore all over/ muscle aches), FATIGUE (fatigue) and PYREXIA (fever at 102.0) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 102 (High) units not reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received provided event onset date.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: starting having a funny taste in her mouth; injection site really bruised; really sore like you would get the flu; cough; rash real red; arm itching; felt like sleeping all day; sore all over/ muscle aches; fatigue; fever at 102.0; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough) and RASH ERYTHEMATOUS (rash real red) in a 51-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 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough), RASH ERYTHEMATOUS (rash real red), PRURITUS (arm itching), SOMNOLENCE (felt like sleeping all day), MYALGIA (sore all over/ muscle aches), FATIGUE (fatigue) and PYREXIA (fever at 102.0). At the time of the report, DYSGEUSIA (starting having a funny taste in her mouth), INJECTION SITE BRUISING (injection site really bruised), INFLUENZA LIKE ILLNESS (really sore like you would get the flu), COUGH (cough), RASH ERYTHEMATOUS (rash real red), PRURITUS (arm itching), SOMNOLENCE (felt like sleeping all day), MYALGIA (sore all over/ muscle aches), FATIGUE (fatigue) and PYREXIA (fever at 102.0) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 102 (High) units not reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received provided event onset date.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Abdominal Pain; No Appetite; Fatigue; Extreme Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal Pain), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue) and HEADACHE (Extreme Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 38K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) and METHOTREXATE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal Pain), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue), HEADACHE (Extreme Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal Pain), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue), HEADACHE (Extreme Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Dizziness; Abdominal Pain; No Appetite; Fatigue; Extreme Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal Pain), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue) and HEADACHE (Extreme Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 38K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) and METHOTREXATE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal Pain), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue), HEADACHE (Extreme Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal Pain), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue), HEADACHE (Extreme Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Allergic reaction to the Covid 19 vaccine; Itchy; Big red spot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction to the Covid 19 vaccine), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Big red spot on her arm) 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction to the Covid 19 vaccine), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Big red spot on her arm). At the time of the report, HYPERSENSITIVITY (Allergic reaction to the Covid 19 vaccine) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown and VACCINATION SITE ERYTHEMA (Big red spot on her arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Reporter contact information and patient demographics were updated.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: diarrhea; stomach ache; sore throat; nausea; body aches; chills; head ache; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach ache), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea) and MYALGIA (body aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 19-Nov-2020. Concomitant products included THYROID (ARMOUR THYROID) and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach ache), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), MYALGIA (body aches), CHILLS (chills) and HEADACHE (head ache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) for Adverse event, at an unspecified dose and frequency and ZINGIBER OFFICINALE (GINGER [ZINGIBER OFFICINALE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach ache), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), MYALGIA (body aches), CHILLS (chills) and HEADACHE (head ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-043709 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain
Clinical narrative: diarrhea; stomach ache; sore throat; nausea; body aches; chills; head ache; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach ache), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea) and MYALGIA (body aches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 19-Nov-2020. Concomitant products included THYROID (ARMOUR THYROID) and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach ache), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), MYALGIA (body aches), CHILLS (chills) and HEADACHE (head ache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL EXTRA STRENGTH) for Adverse event, at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) for Adverse event, at an unspecified dose and frequency and ZINGIBER OFFICINALE (GINGER [ZINGIBER OFFICINALE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach ache), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), MYALGIA (body aches), CHILLS (chills) and HEADACHE (head ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-043709 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Gait disturbance, Myalgia, Somnolence
Clinical narrative: wrists started to hurt again; KEPT SLEEPING; could not even walk; whole body ached; CHILLS; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (KEPT SLEEPING), GAIT DISTURBANCE (could not even walk), ARTHRALGIA (wrists started to hurt again), CHILLS (CHILLS) and MYALGIA (whole body ached) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0001335991) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for Dry eyes, DICLOFENAC, HYDROCHLOROTHIAZIDE, FISH OIL, LEVOTHYROXINE, ADALIMUMAB (HUMIRA), ASCORBIC ACID, ACETYLSALICYLIC ACID (BABY ASPIRIN), ATENOLOL, TRAMADOL, OMEPRAZOLE and SIMVASTATIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (CHILLS). On 29-Jan-2021, the patient experienced SOMNOLENCE (KEPT SLEEPING), GAIT DISTURBANCE (could not even walk) and MYALGIA (whole body ached). On 14-Feb-2021, the patient experienced ARTHRALGIA (wrists started to hurt again). On 15-Feb-2021, SOMNOLENCE (KEPT SLEEPING), GAIT DISTURBANCE (could not even walk), CHILLS (CHILLS) and MYALGIA (whole body ached) had resolved. At the time of the report, ARTHRALGIA (wrists started to hurt again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment medications.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test
Clinical narrative: Had Covid after first shot; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Had Covid after first shot) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had Covid after first shot). At the time of the report, COVID-19 (Had Covid after first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coronavirus test: positive (Inconclusive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Hypoaesthesia, Nodule, Pain in extremity
Clinical narrative: Good bumps just on the left thigh; Arm was little sore; Being tired; Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder; Numb - left thigh/left calf/left shoulder; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder), HYPOAESTHESIA (Numb - left thigh/left calf/left shoulder), NODULE (Good bumps just on the left thigh), DISCOMFORT (Discomfort) and PAIN IN EXTREMITY (Arm was little sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DISCOMFORT (Discomfort). On 04-Feb-2021, the patient experienced PARAESTHESIA (Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder) and HYPOAESTHESIA (Numb - left thigh/left calf/left shoulder). On an unknown date, the patient experienced NODULE (Good bumps just on the left thigh), PAIN IN EXTREMITY (Arm was little sore) and FATIGUE (Being tired). On 10-Feb-2021, PARAESTHESIA (Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder) and HYPOAESTHESIA (Numb - left thigh/left calf/left shoulder) had resolved. At the time of the report, NODULE (Good bumps just on the left thigh), DISCOMFORT (Discomfort), PAIN IN EXTREMITY (Arm was little sore) and FATIGUE (Being tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not take any medications for her symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Good bumps just on the left thigh; Arm was little sore; Being tired; Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder; Numb - left thigh/left calf/left shoulder; Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder), HYPOAESTHESIA (Numb - left thigh/left calf/left shoulder), NODULE (Good bumps just on the left thigh), DISCOMFORT (Discomfort) and PAIN IN EXTREMITY (Arm was little sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DISCOMFORT (Discomfort). On 04-Feb-2021, the patient experienced PARAESTHESIA (Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder) and HYPOAESTHESIA (Numb - left thigh/left calf/left shoulder). On an unknown date, the patient experienced NODULE (Good bumps just on the left thigh), PAIN IN EXTREMITY (Arm was little sore) and FATIGUE (Being tired). On 10-Feb-2021, PARAESTHESIA (Tingling sensation of left side of the body,left thigh(felt like you were pulling spider web) , left calf,left shoulder) and HYPOAESTHESIA (Numb - left thigh/left calf/left shoulder) had resolved. At the time of the report, NODULE (Good bumps just on the left thigh), DISCOMFORT (Discomfort), PAIN IN EXTREMITY (Arm was little sore) and FATIGUE (Being tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not take any medications for her symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rash, Rash pruritic
Clinical narrative: On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch:unknown) Intramuscularly for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced itchy on the neck/pruritus, rash on the neck./rash. on an unknown date the patient experienced fatigue.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 8 Feb 2021 the outcome of itchy on the neck/pruritus was resolved. The outcome of rash on the neck./rash, fatigue was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness at the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness at the injection site) outcome was unknown. Not Provided      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: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: itchy red circle; red splodges; This spontaneous case was reported by a non-health professional and describes the occurrence of ERYTHEMA (red splodges) and PRURITUS (itchy red circle) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALFUZOSIN and SIMVASTATIN 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 12-Feb-2021, the patient experienced ERYTHEMA (red splodges). On 13-Feb-2021, the patient experienced PRURITUS (itchy red circle). On 16-Feb-2021, ERYTHEMA (red splodges) and PRURITUS (itchy red circle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up information received on 26-Apr-2021 Contains No New Information. On 01-Jul-2021: Follow-up information received on 01-Jun-2021 Contains No New Information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Chest discomfort, Cough, Nasal congestion
Clinical narrative: Cough; nasal congestion; nasal congestion progressed to throat; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), NASAL CONGESTION (nasal congestion), PHARYNGITIS (nasal congestion progressed to throat) and CHEST DISCOMFORT (chest congestion) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Sleep apnea and Coronary artery disease. Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN 81), TAMSULOSIN and VITAMIN B12 NOS for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced COUGH (Cough), NASAL CONGESTION (nasal congestion), PHARYNGITIS (nasal congestion progressed to throat) and CHEST DISCOMFORT (chest congestion). On 13-Feb-2021, COUGH (Cough), NASAL CONGESTION (nasal congestion), PHARYNGITIS (nasal congestion progressed to throat) and CHEST DISCOMFORT (chest congestion) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: abnormal (abnormal) abnormal. On an unknown date, Blood pressure measurement: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medication included cholesterol and blood pressure pills.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Significant FU: Event updated, outcome updated, conmeds added, suspect details added.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngitis
Clinical narrative: Cough; nasal congestion; nasal congestion progressed to throat; chest congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), NASAL CONGESTION (nasal congestion), PHARYNGITIS (nasal congestion progressed to throat) and CHEST DISCOMFORT (chest congestion) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Sleep apnea and Coronary artery disease. Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN 81), TAMSULOSIN and VITAMIN B12 NOS for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced COUGH (Cough), NASAL CONGESTION (nasal congestion), PHARYNGITIS (nasal congestion progressed to throat) and CHEST DISCOMFORT (chest congestion). On 13-Feb-2021, COUGH (Cough), NASAL CONGESTION (nasal congestion), PHARYNGITIS (nasal congestion progressed to throat) and CHEST DISCOMFORT (chest congestion) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: abnormal (abnormal) abnormal. On an unknown date, Blood pressure measurement: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medication included cholesterol and blood pressure pills.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Significant FU: Event updated, outcome updated, conmeds added, suspect details added.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diagnostic procedure, Fatigue, Limb discomfort, Lymphadenopathy, Mammogram
Clinical narrative: Arm sensitivity; Tiredness; false positive (benign) swollen right lymph node/Swollen lymph node opposite side of vaccine/Lymph nodes that could be a concern; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Arm sensitivity), LYMPHADENOPATHY (false positive (benign) swollen right lymph node/Swollen lymph node opposite side of vaccine/Lymph nodes that could be a concern) and FATIGUE (Tiredness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 032M20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL and ATORVASTATIN for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 09-Feb-2021, the patient experienced LYMPHADENOPATHY (false positive (benign) swollen right lymph node/Swollen lymph node opposite side of vaccine/Lymph nodes that could be a concern). On an unknown date, the patient experienced LIMB DISCOMFORT (Arm sensitivity) and FATIGUE (Tiredness). At the time of the report, LIMB DISCOMFORT (Arm sensitivity), LYMPHADENOPATHY (false positive (benign) swollen right lymph node/Swollen lymph node opposite side of vaccine/Lymph nodes that could be a concern) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Mammogram: (Positive) false positive (benign) swollen right lymph node. In 2021, Diagnostic procedure: Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Suspect product batch/lot number were updated. Lab data and event were added. On 09-Jul-2021: Patient demographics were updated.