chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Vaccination site hot to touch; Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now; Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site hot to touch), VACCINATION SITE ERYTHEMA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now), VACCINATION SITE URTICARIA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now) and VACCINATION SITE RASH (COVID arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was provided by reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site hot to touch), VACCINATION SITE ERYTHEMA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now), VACCINATION SITE URTICARIA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now) and VACCINATION SITE RASH (COVID arm). At the time of the report, VACCINATION SITE WARMTH (Vaccination site hot to touch), VACCINATION SITE ERYTHEMA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now), VACCINATION SITE URTICARIA (Welt, slightly discolored, red, 1 inch to 2 inches occurred and doubled in size now) and VACCINATION SITE RASH (COVID arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included anti histamine
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Feeling abnormal, Pruritus, Somnolence
Clinical narrative: little bit of itching on elbow; I am falling asleep; not able to function as normal; a little red; tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little bit of itching on elbow), SOMNOLENCE (I am falling asleep), FEELING ABNORMAL (not able to function as normal), ERYTHEMA (a little red) and FATIGUE (tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-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 PRURITUS (little bit of itching on elbow), SOMNOLENCE (I am falling asleep), FEELING ABNORMAL (not able to function as normal), ERYTHEMA (a little red) and FATIGUE (tired). At the time of the report, PRURITUS (little bit of itching on elbow), SOMNOLENCE (I am falling asleep), FEELING ABNORMAL (not able to function as normal), ERYTHEMA (a little red) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Severe pain "stabbing all over my body with knives"; Fever 102; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe pain "stabbing all over my body with knives") and PYREXIA (Fever 102) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included LEVOTHYROXINE for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced PAIN (Severe pain "stabbing all over my body with knives") and PYREXIA (Fever 102). At the time of the report, PAIN (Severe pain "stabbing all over my body with knives") and PYREXIA (Fever 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature: 102 (High) High 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient stated she waited 3 months after having COVID-19 to receive the vaccine. She is not willing to go for the second dose. Event treatment: Tylenol (acetaminophen).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in jaw, Swelling face, Vaccination site pain
Clinical narrative: slight swelling left side of my face; numbness on the left side of my face/slight numbness in left hand; slight pain on the left side of my jaw; pain injection site left arm; This spontaneous case was reported by a patient and describes the occurrence of SWELLING FACE (slight swelling left side of my face), HYPOAESTHESIA (numbness on the left side of my face/slight numbness in left hand), PAIN IN JAW (slight pain on the left side of my jaw) and VACCINATION SITE PAIN (pain injection site left arm) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced SWELLING FACE (slight swelling left side of my face), HYPOAESTHESIA (numbness on the left side of my face/slight numbness in left hand), PAIN IN JAW (slight pain on the left side of my jaw) and VACCINATION SITE PAIN (pain injection site left arm). On 02-May-2021, VACCINATION SITE PAIN (pain injection site left arm) had resolved. At the time of the report, SWELLING FACE (slight swelling left side of my face), HYPOAESTHESIA (numbness on the left side of my face/slight numbness in left hand) and PAIN IN JAW (slight pain on the left side of my jaw) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy; Wheals around left breast; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and URTICARIA (Wheals around left breast) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included OMEPRAZOLE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced URTICARIA (Wheals around left breast). On an unknown date, the patient experienced PRURITUS (Itchy). At the time of the report, PRURITUS (Itchy) and URTICARIA (Wheals around left breast) outcome was unknown. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use also included blood pressure medications.  Treatment information was not provided.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis
Clinical narrative: Coughing up blood; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOPTYSIS (Coughing up blood) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced HAEMOPTYSIS (Coughing up blood). At the time of the report, HAEMOPTYSIS (Coughing up blood) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Lymphadenopathy, Myalgia, Night sweats
Clinical narrative: site of injection is swollen; Site of injection has redness; Site of injection is tender to the touch; Left lymph nodes are swollen on clavicle; Night sweats for 2 nights; Very, very fatigued; Muscle soreness; chills; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats for 2 nights), FATIGUE (Very, very fatigued), MYALGIA (Muscle soreness), CHILLS (chills) and VACCINATION SITE SWELLING (site of injection is swollen) in a 32-year-old male 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 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats for 2 nights), FATIGUE (Very, very fatigued), MYALGIA (Muscle soreness) and CHILLS (chills). On 03-May-2021, the patient experienced VACCINATION SITE SWELLING (site of injection is swollen), VACCINATION SITE ERYTHEMA (Site of injection has redness), VACCINATION SITE PAIN (Site of injection is tender to the touch) and LYMPHADENOPATHY (Left lymph nodes are swollen on clavicle). At the time of the report, NIGHT SWEATS (Night sweats for 2 nights), FATIGUE (Very, very fatigued), MYALGIA (Muscle soreness), CHILLS (chills), VACCINATION SITE SWELLING (site of injection is swollen), VACCINATION SITE ERYTHEMA (Site of injection has redness), VACCINATION SITE PAIN (Site of injection is tender to the touch) and LYMPHADENOPATHY (Left lymph nodes are swollen on clavicle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No known drug allergies.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: site of injection is swollen; Site of injection has redness; Site of injection is tender to the touch; Left lymph nodes are swollen on clavicle; Night sweats for 2 nights; Very, very fatigued; Muscle soreness; chills; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats for 2 nights), FATIGUE (Very, very fatigued), MYALGIA (Muscle soreness), CHILLS (chills) and VACCINATION SITE SWELLING (site of injection is swollen) in a 32-year-old male 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 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats for 2 nights), FATIGUE (Very, very fatigued), MYALGIA (Muscle soreness) and CHILLS (chills). On 03-May-2021, the patient experienced VACCINATION SITE SWELLING (site of injection is swollen), VACCINATION SITE ERYTHEMA (Site of injection has redness), VACCINATION SITE PAIN (Site of injection is tender to the touch) and LYMPHADENOPATHY (Left lymph nodes are swollen on clavicle). At the time of the report, NIGHT SWEATS (Night sweats for 2 nights), FATIGUE (Very, very fatigued), MYALGIA (Muscle soreness), CHILLS (chills), VACCINATION SITE SWELLING (site of injection is swollen), VACCINATION SITE ERYTHEMA (Site of injection has redness), VACCINATION SITE PAIN (Site of injection is tender to the touch) and LYMPHADENOPATHY (Left lymph nodes are swollen on clavicle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No known drug allergies.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: has been feeling like she has the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (has been feeling like she has the flu) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B211A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (has been feeling like she has the flu). At the time of the report, INFLUENZA LIKE ILLNESS (has been feeling like she has the flu) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications includes syrup and flu pills
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Asthenia, Chest pain, Gait disturbance
Clinical narrative: Staggering/ Unsteady; light chest pains; oxygen level went down to 86%; Couldn't stand up; lost taste buds; runny nose; headache; shooting pains in every joint in her body; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (light chest pains), ASTHENIA (Couldn't stand up), GAIT DISTURBANCE (Staggering/ Unsteady), AGEUSIA (lost taste buds) and RHINORRHOEA (runny nose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 at the end of October 2020 which lasted about a month.) in October 2020. Concurrent medical conditions included Diabetes, Hypertension, Hiatal hernia, Heart disease, unspecified and Gout. Concomitant products included LOSARTAN for Blood pressure management, SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes, FUROSEMIDE for Diuretic therapy, ALLOPURINOL for Gout, AMLODIPINE and CLOPIDOGREL for Heart disease, unspecified, OMEPRAZOLE for Hiatal hernia, MONTELUKAST, LEVOTHYROXINE, ACETYLSALICYLIC ACID (aspirin), ROSUVASTATIN CALCIUM and METOPROLOL TARTRATE for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced AGEUSIA (lost taste buds), RHINORRHOEA (runny nose), HEADACHE (headache) and ARTHRALGIA (shooting pains in every joint in her body). On 23-Apr-2021, the patient experienced ASTHENIA (Couldn't stand up). On 24-Apr-2021, the patient experienced CHEST PAIN (light chest pains) and OXYGEN SATURATION DECREASED (oxygen level went down to 86%). On 25-Apr-2021, the patient experienced GAIT DISTURBANCE (Staggering/ Unsteady). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 22-Apr-2021 for Adverse event NOS, at an unspecified dose and frequency. On 24-Apr-2021, CHEST PAIN (light chest pains) and OXYGEN SATURATION DECREASED (oxygen level went down to 86%) had resolved. On 25-Apr-2021, ASTHENIA (Couldn't stand up) and GAIT DISTURBANCE (Staggering/ Unsteady) had resolved. On 26-Apr-2021, AGEUSIA (lost taste buds), RHINORRHOEA (runny nose), HEADACHE (headache) and ARTHRALGIA (shooting pains in every joint in her body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Oxygen saturation: low (Low) oxygen level went down to 86%. On an unknown date, Oxygen saturation: normal (normal) has been 95-99% which is normal for her.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oxygen saturation, Oxygen saturation decreased, Rhinorrhoea
Clinical narrative: Staggering/ Unsteady; light chest pains; oxygen level went down to 86%; Couldn't stand up; lost taste buds; runny nose; headache; shooting pains in every joint in her body; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (light chest pains), ASTHENIA (Couldn't stand up), GAIT DISTURBANCE (Staggering/ Unsteady), AGEUSIA (lost taste buds) and RHINORRHOEA (runny nose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID-19 at the end of October 2020 which lasted about a month.) in October 2020. Concurrent medical conditions included Diabetes, Hypertension, Hiatal hernia, Heart disease, unspecified and Gout. Concomitant products included LOSARTAN for Blood pressure management, SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes, FUROSEMIDE for Diuretic therapy, ALLOPURINOL for Gout, AMLODIPINE and CLOPIDOGREL for Heart disease, unspecified, OMEPRAZOLE for Hiatal hernia, MONTELUKAST, LEVOTHYROXINE, ACETYLSALICYLIC ACID (aspirin), ROSUVASTATIN CALCIUM and METOPROLOL TARTRATE for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced AGEUSIA (lost taste buds), RHINORRHOEA (runny nose), HEADACHE (headache) and ARTHRALGIA (shooting pains in every joint in her body). On 23-Apr-2021, the patient experienced ASTHENIA (Couldn't stand up). On 24-Apr-2021, the patient experienced CHEST PAIN (light chest pains) and OXYGEN SATURATION DECREASED (oxygen level went down to 86%). On 25-Apr-2021, the patient experienced GAIT DISTURBANCE (Staggering/ Unsteady). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 22-Apr-2021 for Adverse event NOS, at an unspecified dose and frequency. On 24-Apr-2021, CHEST PAIN (light chest pains) and OXYGEN SATURATION DECREASED (oxygen level went down to 86%) had resolved. On 25-Apr-2021, ASTHENIA (Couldn't stand up) and GAIT DISTURBANCE (Staggering/ Unsteady) had resolved. On 26-Apr-2021, AGEUSIA (lost taste buds), RHINORRHOEA (runny nose), HEADACHE (headache) and ARTHRALGIA (shooting pains in every joint in her body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Oxygen saturation: low (Low) oxygen level went down to 86%. On an unknown date, Oxygen saturation: normal (normal) has been 95-99% which is normal for her.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a pharmacist and describes the occurrence of URTICARIA (Hives) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced URTICARIA (Hives). The patient was treated with PARACETAMOL (TYLENOL) for Hives, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and HYDROCORTISONE ACETATE (HYDROCORTISONE [HYDROCORTISONE ACETATE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives) outcome was unknown. 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 medication not provided by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Speech disorder, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Could not use her left side; She cannot talk properly; Headache; Injection site was swollen; Injection site was red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (Could not use her left side), SPEECH DISORDER (She cannot talk properly), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04015214) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Naproxen).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red). On 15-Apr-2021, the patient experienced HYPOKINESIA (Could not use her left side) and SPEECH DISORDER (She cannot talk properly). At the time of the report, HYPOKINESIA (Could not use her left side), SPEECH DISORDER (She cannot talk properly), HEADACHE (Headache), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE ERYTHEMA (Injection site was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient could not hold phone with her left hand. The patient had been to doctor and was given a cream.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Patient out of country and did not get 2nd vaccine as scheduled; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient out of country and did not get 2nd vaccine as scheduled) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient out of country and did not get 2nd vaccine as scheduled). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Patient out of country and did not get 2nd vaccine as scheduled) outcome was unknown. 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. Treatment information was not provided. The patient's second dose was scheduled on 24 Apr 2021 but was not taken due to his busy schedule. Enquired  whether he have to start the series all over or will it be effective even if we take the second dose.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was administered 53 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered 53 days after the first dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027132A and 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D2, VITAMIN D3, MULTIVITAMIN [VITAMINS NOS] and MIRABEGRON (MYRBETRIQ) for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered 53 days after the first dose). On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered 53 days after the first dose) had resolved. Not Provided          Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Tenderness
Clinical narrative: Red Spots on both Hands and Fingers; Tender Spots on both Hands and Fingers; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red Spots on both Hands and Fingers) and TENDERNESS (Tender Spots on both Hands and Fingers) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced RASH MACULAR (Red Spots on both Hands and Fingers) and TENDERNESS (Tender Spots on both Hands and Fingers). At the time of the report, RASH MACULAR (Red Spots on both Hands and Fingers) and TENDERNESS (Tender Spots on both Hands and Fingers) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant medical history provided.  Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Hypotension, Nausea
Clinical narrative: Blood pressure low; Paleness; weakness; Tiredness; Headaches; Nausea; throwing up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure low), PALLOR (Paleness), ASTHENIA (weakness), FATIGUE (Tiredness) and HEADACHE (Headaches) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced HYPOTENSION (Blood pressure low), PALLOR (Paleness), ASTHENIA (weakness), FATIGUE (Tiredness), HEADACHE (Headaches), NAUSEA (Nausea) and VOMITING (throwing up). On 19-Apr-2021, HYPOTENSION (Blood pressure low), PALLOR (Paleness), ASTHENIA (weakness), FATIGUE (Tiredness), HEADACHE (Headaches), NAUSEA (Nausea) and VOMITING (throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment included ibuprofen for headaches.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: additional information events and contact information updated
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Vomiting
Clinical narrative: Blood pressure low; Paleness; weakness; Tiredness; Headaches; Nausea; throwing up; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure low), PALLOR (Paleness), ASTHENIA (weakness), FATIGUE (Tiredness) and HEADACHE (Headaches) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced HYPOTENSION (Blood pressure low), PALLOR (Paleness), ASTHENIA (weakness), FATIGUE (Tiredness), HEADACHE (Headaches), NAUSEA (Nausea) and VOMITING (throwing up). On 19-Apr-2021, HYPOTENSION (Blood pressure low), PALLOR (Paleness), ASTHENIA (weakness), FATIGUE (Tiredness), HEADACHE (Headaches), NAUSEA (Nausea) and VOMITING (throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment included ibuprofen for headaches.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: additional information events and contact information updated
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Furuncle, Lymphadenopathy, Tenderness
Clinical narrative: Breaking out in little boils; Tender; Swollen lymph node; Right collar bone is raised; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Right collar bone is raised), FURUNCLE (Breaking out in little boils), TENDERNESS (Tender) and LYMPHADENOPATHY (Swollen lymph node) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced BONE PAIN (Right collar bone is raised), TENDERNESS (Tender) and LYMPHADENOPATHY (Swollen lymph node). On 21-May-2021, the patient experienced FURUNCLE (Breaking out in little boils). At the time of the report, BONE PAIN (Right collar bone is raised), FURUNCLE (Breaking out in little boils), TENDERNESS (Tender) and LYMPHADENOPATHY (Swollen lymph node) had not resolved.            Patient's health care professional said that  breaking out in little boils are a swollen lymph node.Preferred contact is phone number and consent given for Safety to give her a call back. Concomitant medications were not reported. Treatment details not provided.    This case was linked to MOD-2021-200689 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Additional information added and contains information regarding second dose vaccine and updated and event(breaking out in little boils)updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Minor arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Minor arm pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, AMLODIPINE and METOPROLOL for Blood pressure management, SIMVASTATIN for an unknown indication.    On 26-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 PAIN IN EXTREMITY (Minor arm pain). At the time of the report, PAIN IN EXTREMITY (Minor arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-032153 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness / Patient has to get up pretty slow due to dizziness; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness / Patient has to get up pretty slow due to dizziness) and VERTIGO (Vertigo) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No relevant medical history provided.     On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DIZZINESS (Dizziness / Patient has to get up pretty slow due to dizziness) and VERTIGO (Vertigo). At the time of the report, DIZZINESS (Dizziness / Patient has to get up pretty slow due to dizziness) and VERTIGO (Vertigo) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment medication included- Vertigo medication
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (Headache), MYALGIA (muscle aches) and FATIGUE ( tired) in an elderly patient of an unknown gender 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) at an unspecified dose. On an unknown date, the patient experienced DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (Headache), MYALGIA (muscle aches) and FATIGUE ( tired). At the time of the report, DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (Headache), MYALGIA (muscle aches) and FATIGUE ( tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The Patient was over 60 years old and was tired,no appetite, weakness, muscle aches, and headache. Treatment information was not provided. This case was linked to MOD21-085592, MOD21-085383, US-MODERNATX, INC.-MOD-2021-101650 (E2B Linked Report).; Sender's Comments:  MOD21-085592: MOD21-085383: US-MODERNATX, INC.-MOD-2021-101650:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Cough, Vaccination site pain, Vaccination site swelling
Clinical narrative: Dry cough; A bump on his armpit; Swelling at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), AXILLARY MASS (A bump on his armpit), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced COUGH (Dry cough), AXILLARY MASS (A bump on his armpit), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Dry cough), AXILLARY MASS (A bump on his armpit), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            Treatment medications also included a cream. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-101728 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, 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) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up received on 31-May-2021 contains no significant information.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: shot not administered within 36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shot not administered within 36 days) in a 67-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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shot not administered within 36 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shot not administered within 36 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Depression, Fatigue, Feeling abnormal
Clinical narrative: decided not to take 2nd dose; tired, fatigued; joints hurt; headaches; swollen at the injection site; sore at the injection site; injection site red knot; depressed; had foggy thinking.; slept like 20 hours; injection site red knot that was about 4 inches across; joints hurt 10 times more than normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across) and CONDITION AGGRAVATED (joints hurt 10 times more than normal) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HLA-B*27 positive, Antinuclear antibodies present (SSB/LA antigens. I have autoimmune antigens in my blood, but they're not real strong.), Macrocytosis, Joint pain and Ill-defined disorder (I have 10 or 15 separate diagnoses).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across), CONDITION AGGRAVATED (joints hurt 10 times more than normal), FATIGUE (tired, fatigued), ARTHRALGIA (joints hurt), HEADACHE (headaches), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE ERYTHEMA (injection site red knot). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (decided not to take 2nd dose). At the time of the report, DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across), CONDITION AGGRAVATED (joints hurt 10 times more than normal), FATIGUE (tired, fatigued), ARTHRALGIA (joints hurt), HEADACHE (headaches), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE ERYTHEMA (injection site red knot) was resolving and PRODUCT DOSE OMISSION ISSUE (decided not to take 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Product dose omission issue, Vaccination site erythema, Vaccination site nodule
Clinical narrative: decided not to take 2nd dose; tired, fatigued; joints hurt; headaches; swollen at the injection site; sore at the injection site; injection site red knot; depressed; had foggy thinking.; slept like 20 hours; injection site red knot that was about 4 inches across; joints hurt 10 times more than normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across) and CONDITION AGGRAVATED (joints hurt 10 times more than normal) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HLA-B*27 positive, Antinuclear antibodies present (SSB/LA antigens. I have autoimmune antigens in my blood, but they're not real strong.), Macrocytosis, Joint pain and Ill-defined disorder (I have 10 or 15 separate diagnoses).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across), CONDITION AGGRAVATED (joints hurt 10 times more than normal), FATIGUE (tired, fatigued), ARTHRALGIA (joints hurt), HEADACHE (headaches), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE ERYTHEMA (injection site red knot). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (decided not to take 2nd dose). At the time of the report, DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across), CONDITION AGGRAVATED (joints hurt 10 times more than normal), FATIGUE (tired, fatigued), ARTHRALGIA (joints hurt), HEADACHE (headaches), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE ERYTHEMA (injection site red knot) was resolving and PRODUCT DOSE OMISSION ISSUE (decided not to take 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: decided not to take 2nd dose; tired, fatigued; joints hurt; headaches; swollen at the injection site; sore at the injection site; injection site red knot; depressed; had foggy thinking.; slept like 20 hours; injection site red knot that was about 4 inches across; joints hurt 10 times more than normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across) and CONDITION AGGRAVATED (joints hurt 10 times more than normal) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HLA-B*27 positive, Antinuclear antibodies present (SSB/LA antigens. I have autoimmune antigens in my blood, but they're not real strong.), Macrocytosis, Joint pain and Ill-defined disorder (I have 10 or 15 separate diagnoses).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across), CONDITION AGGRAVATED (joints hurt 10 times more than normal), FATIGUE (tired, fatigued), ARTHRALGIA (joints hurt), HEADACHE (headaches), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE ERYTHEMA (injection site red knot). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (decided not to take 2nd dose). At the time of the report, DEPRESSION (depressed), FEELING ABNORMAL (had foggy thinking.), HYPERSOMNIA (slept like 20 hours), VACCINATION SITE NODULE (injection site red knot that was about 4 inches across), CONDITION AGGRAVATED (joints hurt 10 times more than normal), FATIGUE (tired, fatigued), ARTHRALGIA (joints hurt), HEADACHE (headaches), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE PAIN (sore at the injection site) and VACCINATION SITE ERYTHEMA (injection site red knot) was resolving and PRODUCT DOSE OMISSION ISSUE (decided not to take 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Lethargy, Pyrexia
Clinical narrative: Over all bad feeling; Lethargic; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Over all bad feeling), LETHARGY (Lethargic), PYREXIA (Fever) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history provided.  Concomitant products included ESTRADIOL, MELOXICAM, AMLODIPINE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FEELING ABNORMAL (Over all bad feeling), LETHARGY (Lethargic), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 09-Apr-2021, FEELING ABNORMAL (Over all bad feeling), LETHARGY (Lethargic), PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including hormone injection 1 cc Q mo(unsure of spelling "depotestro") was reported.