chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling cold, Respiratory disorder
Clinical narrative: upper respiratory issues; feels cold; has no appetite; chills; tired and fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (upper respiratory issues), FEELING COLD (feels cold), DECREASED APPETITE (has no appetite), CHILLS (chills) and FATIGUE (tired and fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20 and 042L20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPRIN), ROSUVASTATIN and INSULIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced RESPIRATORY DISORDER (upper respiratory issues), FEELING COLD (feels cold), DECREASED APPETITE (has no appetite), CHILLS (chills) and FATIGUE (tired and fatigue). At the time of the report, RESPIRATORY DISORDER (upper respiratory issues), FEELING COLD (feels cold), DECREASED APPETITE (has no appetite), CHILLS (chills) and FATIGUE (tired and fatigue) outcome was unknown.            Treatment information was not provided
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: Feeling terrible; Muscle aches; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feeling terrible) and MYALGIA (Muscle aches) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included MELOXICAM for an unknown indication.    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 FEELING ABNORMAL (Feeling terrible) and MYALGIA (Muscle aches). At the time of the report, FEELING ABNORMAL (Feeling terrible) and MYALGIA (Muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Numb tongue; Numb lips; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb tongue) and HYPOAESTHESIA ORAL (Numb lips) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Numb tongue) and HYPOAESTHESIA ORAL (Numb lips). On 09-Mar-2021, HYPOAESTHESIA ORAL (Numb tongue) and HYPOAESTHESIA ORAL (Numb lips) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications details were reported by the reporter. Treatment details was not reported by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pinkish on left arm of injection), VACCINATION SITE PRURITUS (Itchiness on left arm of injection), VACCINATION SITE PAIN (Tenderness left arm of injection) and VACCINATION SITE ERYTHEMA (Redness on left arm of injection) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy. Concomitant products included METFORMIN for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pinkish on left arm of injection), VACCINATION SITE PRURITUS (Itchiness on left arm of injection), VACCINATION SITE PAIN (Tenderness left arm of injection) and VACCINATION SITE ERYTHEMA (Redness on left arm of injection). At the time of the report, VACCINATION SITE DISCOLOURATION (Pinkish on left arm of injection), VACCINATION SITE PRURITUS (Itchiness on left arm of injection), VACCINATION SITE PAIN (Tenderness left arm of injection) and VACCINATION SITE ERYTHEMA (Redness on left arm of injection) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's concomitant medications include statin (unspecified).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizziness; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PYREXIA (Low grade fever) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (Dizziness) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. On 06-Mar-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, PYREXIA (Low grade fever) had resolved.            No concomitant medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Rash
Clinical narrative: Can't Sleep; Itches; Huge Rash; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can't Sleep), PRURITUS (Itches) and RASH (Huge Rash) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006N20A) 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 01-Mar-2021, the patient experienced INSOMNIA (Can't Sleep), PRURITUS (Itches) and RASH (Huge Rash). At the time of the report, INSOMNIA (Can't Sleep), PRURITUS (Itches) and RASH (Huge Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information included Cream
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 100 degrees Fahrenheit; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever of 100 degrees Fahrenheit) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (fever of 100 degrees Fahrenheit). The patient was treated with IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever of 100 degrees Fahrenheit) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was very sore). At the time of the report, PAIN IN EXTREMITY (arm was very sore) outcome was unknown. Not Provided          No concomitant medications was reported Treatment information provided as "Ice" to treat the events
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node under chin  in throat; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (swollen lymph node under chin  in throat) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node under chin  in throat). At the time of the report, LYMPHADENOPATHY (swollen lymph node under chin  in throat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment medication was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: high blood pressure; itchy at injection site; puffy at injection site; red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE SWELLING (puffy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (carries an EpiPen).    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERTENSION (high blood pressure), VACCINATION SITE PRURITUS (itchy at injection site), VACCINATION SITE SWELLING (puffy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, HYPERTENSION (high blood pressure) and VACCINATION SITE PRURITUS (itchy at injection site) outcome was unknown and VACCINATION SITE SWELLING (puffy at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: 90 to 150 (abnormal) blood pressure went from  90 to 150..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. Treatment information was not provided.     This case was linked to MOD-2021-210107 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CLOPIDOGREL, METOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID] and POTASSIUM for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 11-Mar-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered from a vial punctured more than 18 hours ago; A spontaneous report was received from a pharmacist, concerning a 26-year-old male patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine administered from a vial punctured more than 18 hours ago/expired product administered.             The patient's medical history and concomitant history wa not reported                      On 11 Mar 2021,  the patient received their first of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 11 Mar 2021, the patient received a dose the Moderna COVID-19 vaccine that had been previous punctured more than 18 hours prior to his vaccination.  The Action taken with the first dose of mRNA-1273 in response to the event was unknown.  The  outcome of the event, vaccine administered from a vial punctured more than 18 hours ago/expired product administered, was considered resolved on 11 Mar 2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Illness, Nausea
Clinical narrative: Dizzy; Weak; Sick; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weak), ILLNESS (Sick) and NAUSEA (Nauseated) 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Weak), ILLNESS (Sick) and NAUSEA (Nauseated). At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Weak), ILLNESS (Sick) and NAUSEA (Nauseated) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: soreness, aches, pains; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness, aches, pains) and FATIGUE (fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00-B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (soreness, aches, pains) and FATIGUE (fatigue). At the time of the report, PAIN (soreness, aches, pains) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment details were provided. treatment to the events not provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 90-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 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 DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (PEPTO DIARRHEA CONTROL) on 06-Mar-2021 at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: pain was sever and tender to touch.; fever with temperature of 99.4; chills; arm pain, couldn't move or lift his arm above 45 degrees; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain, couldn't move or lift his arm above 45 degrees), INFLUENZA LIKE ILLNESS (flu like symptoms), TENDERNESS (pain was sever and tender to touch.), PYREXIA (fever with temperature of 99.4) and CHILLS (chills) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     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 (arm pain, couldn't move or lift his arm above 45 degrees), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever with temperature of 99.4) and CHILLS (chills). On an unknown date, the patient experienced TENDERNESS (pain was sever and tender to touch.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain, couldn't move or lift his arm above 45 degrees), INFLUENZA LIKE ILLNESS (flu like symptoms), TENDERNESS (pain was sever and tender to touch.), PYREXIA (fever with temperature of 99.4) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 99.4 (High) temperature of 99.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: pain was sever and tender to touch.; fever with temperature of 99.4; chills; arm pain, couldn't move or lift his arm above 45 degrees; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain, couldn't move or lift his arm above 45 degrees), INFLUENZA LIKE ILLNESS (flu like symptoms), TENDERNESS (pain was sever and tender to touch.), PYREXIA (fever with temperature of 99.4) and CHILLS (chills) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     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 (arm pain, couldn't move or lift his arm above 45 degrees), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever with temperature of 99.4) and CHILLS (chills). On an unknown date, the patient experienced TENDERNESS (pain was sever and tender to touch.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain, couldn't move or lift his arm above 45 degrees), INFLUENZA LIKE ILLNESS (flu like symptoms), TENDERNESS (pain was sever and tender to touch.), PYREXIA (fever with temperature of 99.4) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 99.4 (High) temperature of 99.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin
Clinical narrative: dry skin all over the top part of head; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (dry skin all over the top part of head) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and FENOFIBRATE for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DRY SKIN (dry skin all over the top part of head). At the time of the report, DRY SKIN (dry skin all over the top part of head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient provided lot number as 013A21A or 013A214. Treatment include Soap.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness; head spinning; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness) and VERTIGO (head spinning) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness) and VERTIGO (head spinning). At the time of the report, DIZZINESS (dizziness) had not resolved and VERTIGO (head spinning) 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.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received captured event outcome.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her abdomen; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her abdomen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH (rash on her abdomen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. At the time of the report, RASH (rash on her abdomen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Nausea
Clinical narrative: stomach pain; Chills; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain), CHILLS (Chills), HEADACHE (headache) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain), CHILLS (Chills), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), CHILLS (Chills), HEADACHE (headache) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feeling tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012A214) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included CARBIDOPA, LEVODOPA (LEVODOPA/CARBIDOPA), INSULIN, ESCITALOPRAM OXALATE (LEXAPRO), COLECALCIFEROL (VITAMIN D 3), ACETYLSALICYLIC ACID (BABY ASPIRIN), RIVASTIGMINE, SIMVASTATIN, MELATONIN, CALCIUM LEVOMEFOLATE (DEPLIN [CALCIUM LEVOMEFOLATE]) and MULTI VIT for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feeling tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feeling tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-051280 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: dizziness; soreness at the site of injection in his left (nondominant) arm.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and VACCINATION SITE PAIN (soreness at the site of injection in his left (nondominant) arm.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (dizziness) and VACCINATION SITE PAIN (soreness at the site of injection in his left (nondominant) arm.). At the time of the report, DIZZINESS (dizziness) and VACCINATION SITE PAIN (soreness at the site of injection in his left (nondominant) arm.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use included unspecified diabetes medication daily. No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: COVID Arm; COVID Arm (red, hard, itchy); COVID Arm (red, hard, itchy); COVID Arm (red, hard, itchy); Sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE INDURATION (COVID Arm (red, hard, itchy)), VACCINATION SITE PRURITUS (COVID Arm (red, hard, itchy)) and VACCINATION SITE ERYTHEMA (COVID Arm (red, hard, itchy)) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Genital herpes (Genital herpes IgG was Positive IgM was negative) in 2005.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE INDURATION (COVID Arm (red, hard, itchy)), VACCINATION SITE PRURITUS (COVID Arm (red, hard, itchy)) and VACCINATION SITE ERYTHEMA (COVID Arm (red, hard, itchy)). On 12-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 21-Jan-2021, VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE INDURATION (COVID Arm (red, hard, itchy)), VACCINATION SITE PRURITUS (COVID Arm (red, hard, itchy)) and VACCINATION SITE ERYTHEMA (COVID Arm (red, hard, itchy)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-207871 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Feeling abnormal, Headache, Hypoaesthesia oral
Clinical narrative: Palms have been glowing red; left leg hurts really hurts; body aches; slight headache; teeth, lip and tongue are numb; Felt something in mouth but didn't manifest them; uncomfortable; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (uncomfortable), HYPOAESTHESIA ORAL (teeth, lip and tongue are numb), FEELING ABNORMAL (Felt something in mouth but didn't manifest them), ERYTHEMA (Palms have been glowing red) and PAIN IN EXTREMITY (left leg hurts really hurts) in a 76-year-old female 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.     Concurrent medical conditions included Blood pressure abnormal and Heart rate irregular. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, METOPROLOL for Blood pressure abnormal and Heart rate irregular, ENALAPRIL for Heartbeats irregular, POTASSIUM, MAGNESIUM, VITAMIN B COMPLEX and ASCORBIC ACID (VIT C) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DISCOMFORT (uncomfortable) and FEELING ABNORMAL (Felt something in mouth but didn't manifest them). On 06-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (teeth, lip and tongue are numb). On an unknown date, the patient experienced ERYTHEMA (Palms have been glowing red), PAIN IN EXTREMITY (left leg hurts really hurts), MYALGIA (body aches) and HEADACHE (slight headache). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia and Leg pain, at a dose of 1 dosage form. At the time of the report, DISCOMFORT (uncomfortable), HYPOAESTHESIA ORAL (teeth, lip and tongue are numb) and FEELING ABNORMAL (Felt something in mouth but didn't manifest them) had not resolved and ERYTHEMA (Palms have been glowing red), PAIN IN EXTREMITY (left leg hurts really hurts), MYALGIA (body aches) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received captured no new information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Palms have been glowing red; left leg hurts really hurts; body aches; slight headache; teeth, lip and tongue are numb; Felt something in mouth but didn't manifest them; uncomfortable; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (uncomfortable), HYPOAESTHESIA ORAL (teeth, lip and tongue are numb), FEELING ABNORMAL (Felt something in mouth but didn't manifest them), ERYTHEMA (Palms have been glowing red) and PAIN IN EXTREMITY (left leg hurts really hurts) in a 76-year-old female 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.     Concurrent medical conditions included Blood pressure abnormal and Heart rate irregular. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, METOPROLOL for Blood pressure abnormal and Heart rate irregular, ENALAPRIL for Heartbeats irregular, POTASSIUM, MAGNESIUM, VITAMIN B COMPLEX and ASCORBIC ACID (VIT C) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DISCOMFORT (uncomfortable) and FEELING ABNORMAL (Felt something in mouth but didn't manifest them). On 06-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (teeth, lip and tongue are numb). On an unknown date, the patient experienced ERYTHEMA (Palms have been glowing red), PAIN IN EXTREMITY (left leg hurts really hurts), MYALGIA (body aches) and HEADACHE (slight headache). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia and Leg pain, at a dose of 1 dosage form. At the time of the report, DISCOMFORT (uncomfortable), HYPOAESTHESIA ORAL (teeth, lip and tongue are numb) and FEELING ABNORMAL (Felt something in mouth but didn't manifest them) had not resolved and ERYTHEMA (Palms have been glowing red), PAIN IN EXTREMITY (left leg hurts really hurts), MYALGIA (body aches) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional information received captured no new information.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pain in extremity, Pruritus
Clinical narrative: Itching all over body; Redness; Chills; Arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching all over body), ERYTHEMA (Redness), PAIN IN EXTREMITY (Arm was sore) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease stage 4. Concomitant products included TORSEMIDE, ALLOPURINOL, DILTIAZEM, MONTELUKAST, GABAPENTIN, ESCITALOPRAM, PRAVASTATIN, PRAMIPEXOLE, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), PARACETAMOL (TYLENOL), VITAMIN D3 and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 08-Mar-2021, the patient experienced PRURITUS (Itching all over body), ERYTHEMA (Redness) and CHILLS (Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, PRURITUS (Itching all over body), ERYTHEMA (Redness), PAIN IN EXTREMITY (Arm was sore) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       For her symptoms her doctor told her use ice packs.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea
Clinical narrative: Next morning diarrhea; Next morning for 2 hours nausea; Fatigue that day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Next morning diarrhea), FATIGUE (Fatigue that day) and NAUSEA (Next morning for 2 hours nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep disorder NOS. Concomitant products included TRAZODONE for Sleep disorder NOS, FLUOXETINE HYDROCHLORIDE (PROZAC), LAMOTRIGINE (LAMICTAL) and VITAMIN B COMPLEX for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Fatigue that day). On 10-Mar-2021, the patient experienced DIARRHOEA (Next morning diarrhea) and NAUSEA (Next morning for 2 hours nausea). On 09-Mar-2021, FATIGUE (Fatigue that day) had resolved. On 10-Mar-2021, NAUSEA (Next morning for 2 hours nausea) had resolved. At the time of the report, DIARRHOEA (Next morning diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took coffee for fatigue and it  went away.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Epicondylitis, Product dose omission issue
Clinical narrative: unable to complete the vaccination series; tennis elbow; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (unable to complete the vaccination series) and EPICONDYLITIS (tennis elbow) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse (asymptomatic). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) and VITAMINS NOS for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (unable to complete the vaccination series) and EPICONDYLITIS (tennis elbow). At the time of the report, PRODUCT DOSE OMISSION ISSUE (unable to complete the vaccination series) had resolved and EPICONDYLITIS (tennis elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was prescribed unspecified steroids for tennis elbow.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: some redness and itching on wrist and side of her fingers; some redness and itching on wrist and side of her fingers; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (some redness and itching on wrist and side of her fingers) and PRURITUS (some redness and itching on wrist and side of her fingers) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A214 and 030M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included CARBIDOPA, LEVODOPA (LEVODOPA/CARBIDOPA), INSULIN, ESCITALOPRAM OXALATE (LEXAPRO), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ACETYLSALICYLIC ACID (BABY ASPIRIN), RIVASTIGMINE, SIMVASTATIN, CALCIUM LEVOMEFOLATE (DEPLIN [CALCIUM LEVOMEFOLATE]), MELATONIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced ERYTHEMA (some redness and itching on wrist and side of her fingers) and PRURITUS (some redness and itching on wrist and side of her fingers). At the time of the report, ERYTHEMA (some redness and itching on wrist and side of her fingers) and PRURITUS (some redness and itching on wrist and side of her fingers) outcome was unknown.            No treatment information was provided.   This case was linked to MOD21-051280 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Limb discomfort, Pain in extremity
Clinical narrative: Pain on arm; pain on his arm and difficulty moving it; Chills; Headaches; Fatigue; Swelling on his armpit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on arm), LIMB DISCOMFORT (pain on his arm and difficulty moving it), SWELLING (Swelling on his armpit), CHILLS (Chills) and HEADACHE (Headaches) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A2PA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Cholesterol.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced SWELLING (Swelling on his armpit). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain on arm), LIMB DISCOMFORT (pain on his arm and difficulty moving it), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain on arm), LIMB DISCOMFORT (pain on his arm and difficulty moving it), SWELLING (Swelling on his armpit), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent medical conditions included Diabetes and Cholesterol.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Pain on arm; pain on his arm and difficulty moving it; Chills; Headaches; Fatigue; Swelling on his armpit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on arm), LIMB DISCOMFORT (pain on his arm and difficulty moving it), SWELLING (Swelling on his armpit), CHILLS (Chills) and HEADACHE (Headaches) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A2PA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Cholesterol.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced SWELLING (Swelling on his armpit). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain on arm), LIMB DISCOMFORT (pain on his arm and difficulty moving it), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain on arm), LIMB DISCOMFORT (pain on his arm and difficulty moving it), SWELLING (Swelling on his armpit), CHILLS (Chills), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent medical conditions included Diabetes and Cholesterol.
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 50 days between first and second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (50 days between first and second dose) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced OFF LABEL USE (50 days between first and second dose). At the time of the report, OFF LABEL USE (50 days between first and second dose) outcome was unknown. 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.   No concomitant medication was included. No treatment medication was provided.  Rescheduling was not made on time so the second dose passed the 42 days limit.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the arm of the injection) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disorder.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness on the arm of the injection). At the time of the report, PAIN IN EXTREMITY (Soreness on the arm of the injection) had resolved. Not Provided          Action taken with mRNA-1273 moderna vaccine with event was not applicable. Concurrent medical conditions included Diabetes and Heart disorder. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-041113, MOD-2021-041113 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Aug-2020 and the estimated date of delivery was 02-May-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy. On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Internal review on 20-Jul-2021 resulted in updates to the pregnancy information.