chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Vaccination site erythema
Clinical narrative: dizziness; fatigue; nausea; chills; warm to the touch at the injection site; injection site arm was sore/ Injection site arm was tender; Injection site arm was red; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PAIN (injection site arm was sore/ Injection site arm was tender), VACCINATION SITE ERYTHEMA (Injection site arm was red) and FATIGUE (fatigue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) 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 17-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PAIN (injection site arm was sore/ Injection site arm was tender) and VACCINATION SITE ERYTHEMA (Injection site arm was red). On 01-May-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills). On 21-Apr-2021, VACCINATION SITE WARMTH (warm to the touch at the injection site) and VACCINATION SITE ERYTHEMA (Injection site arm was red) had resolved, VACCINATION SITE PAIN (injection site arm was sore/ Injection site arm was tender) outcome was unknown. At the time of the report, DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MODERNATX, INC.-MOD-2021-114449 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-114449:crosslinked; husband case
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: dizziness; fatigue; nausea; chills; warm to the touch at the injection site; injection site arm was sore/ Injection site arm was tender; Injection site arm was red; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PAIN (injection site arm was sore/ Injection site arm was tender), VACCINATION SITE ERYTHEMA (Injection site arm was red) and FATIGUE (fatigue) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) 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 17-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch at the injection site), VACCINATION SITE PAIN (injection site arm was sore/ Injection site arm was tender) and VACCINATION SITE ERYTHEMA (Injection site arm was red). On 01-May-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills). On 21-Apr-2021, VACCINATION SITE WARMTH (warm to the touch at the injection site) and VACCINATION SITE ERYTHEMA (Injection site arm was red) had resolved, VACCINATION SITE PAIN (injection site arm was sore/ Injection site arm was tender) outcome was unknown. At the time of the report, DIZZINESS (dizziness), FATIGUE (fatigue), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MODERNATX, INC.-MOD-2021-114449 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-114449:crosslinked; husband case
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Condition aggravated, Fatigue, Motor dysfunction
Clinical narrative: Cant get out of bed for the last three days; Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands; Extreme swelling of joint in fingers; Unable to hold or grasp anything; It is increasingly getting worse; Extremely painful hands; Extremely painful arms; Cant get out of bed for the last three days; Extreme fatigue, I am so fatigue that I cant do anything; I am so fatigue that I cant do anything; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Cant get out of bed for the last three days), PAIN IN EXTREMITY (Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands), PERIPHERAL SWELLING (Extreme swelling of joint in fingers), MOTOR DYSFUNCTION (Unable to hold or grasp anything) and CONDITION AGGRAVATED (It is increasingly getting worse) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Immunocompromised and Arthritis aggravated (Sjogren´s which is a severe form of arthritis). Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 29-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 ASTHENIA (Cant get out of bed for the last three days), PAIN IN EXTREMITY (Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands), PERIPHERAL SWELLING (Extreme swelling of joint in fingers), MOTOR DYSFUNCTION (Unable to hold or grasp anything), CONDITION AGGRAVATED (It is increasingly getting worse), PAIN IN EXTREMITY (Extremely painful hands), PAIN IN EXTREMITY (Extremely painful arms), BEDRIDDEN (Cant get out of bed for the last three days), FATIGUE (Extreme fatigue, I am so fatigue that I cant do anything) and FATIGUE (I am so fatigue that I cant do anything). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, ASTHENIA (Cant get out of bed for the last three days), PAIN IN EXTREMITY (Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands), PERIPHERAL SWELLING (Extreme swelling of joint in fingers), MOTOR DYSFUNCTION (Unable to hold or grasp anything), CONDITION AGGRAVATED (It is increasingly getting worse), PAIN IN EXTREMITY (Extremely painful hands), PAIN IN EXTREMITY (Extremely painful arms), BEDRIDDEN (Cant get out of bed for the last three days), FATIGUE (Extreme fatigue, I am so fatigue that I cant do anything) and FATIGUE (I am so fatigue that I cant do anything) outcome was unknown.        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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Cant get out of bed for the last three days; Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands; Extreme swelling of joint in fingers; Unable to hold or grasp anything; It is increasingly getting worse; Extremely painful hands; Extremely painful arms; Cant get out of bed for the last three days; Extreme fatigue, I am so fatigue that I cant do anything; I am so fatigue that I cant do anything; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Cant get out of bed for the last three days), PAIN IN EXTREMITY (Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands), PERIPHERAL SWELLING (Extreme swelling of joint in fingers), MOTOR DYSFUNCTION (Unable to hold or grasp anything) and CONDITION AGGRAVATED (It is increasingly getting worse) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Immunocompromised and Arthritis aggravated (Sjogren´s which is a severe form of arthritis). Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 29-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 ASTHENIA (Cant get out of bed for the last three days), PAIN IN EXTREMITY (Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands), PERIPHERAL SWELLING (Extreme swelling of joint in fingers), MOTOR DYSFUNCTION (Unable to hold or grasp anything), CONDITION AGGRAVATED (It is increasingly getting worse), PAIN IN EXTREMITY (Extremely painful hands), PAIN IN EXTREMITY (Extremely painful arms), BEDRIDDEN (Cant get out of bed for the last three days), FATIGUE (Extreme fatigue, I am so fatigue that I cant do anything) and FATIGUE (I am so fatigue that I cant do anything). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, ASTHENIA (Cant get out of bed for the last three days), PAIN IN EXTREMITY (Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands), PERIPHERAL SWELLING (Extreme swelling of joint in fingers), MOTOR DYSFUNCTION (Unable to hold or grasp anything), CONDITION AGGRAVATED (It is increasingly getting worse), PAIN IN EXTREMITY (Extremely painful hands), PAIN IN EXTREMITY (Extremely painful arms), BEDRIDDEN (Cant get out of bed for the last three days), FATIGUE (Extreme fatigue, I am so fatigue that I cant do anything) and FATIGUE (I am so fatigue that I cant do anything) outcome was unknown.        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.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Pain in extremity, Rash, Somnolence
Clinical narrative: Pain in arm; drowsiness and could not put head together; anxiety; Rash on his palm/Rash on his hand/Rash looks like eczema; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (drowsiness and could not put head together), ANXIETY (anxiety) and RASH (Rash on his palm/Rash on his hand/Rash looks like eczema) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-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 PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (drowsiness and could not put head together), ANXIETY (anxiety) and RASH (Rash on his palm/Rash on his hand/Rash looks like eczema). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) at a dose of 25 mg and MUPIROCIN at a dose of 2 %. At the time of the report, PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (drowsiness and could not put head together), ANXIETY (anxiety) and RASH (Rash on his palm/Rash on his hand/Rash looks like eczema) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.    This case was linked to MOD-2021-114485, MOD-2021-114485 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Feeling of body temperature change, Headache
Clinical narrative: flu like symptoms; shortness of breath, smoker but hasn't been smoking; more and more mucous; Coughing; cold and hot; Chills; Headache; splitting up all day; arm was hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting really bad), INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (shortness of breath, smoker but hasn't been smoking), SECRETION DISCHARGE (more and more mucous) and COUGH (Coughing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting really bad). On 01-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (shortness of breath, smoker but hasn't been smoking), SECRETION DISCHARGE (more and more mucous), COUGH (Coughing), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), CHILLS (Chills), HEADACHE (Headache) and VOMITING (splitting up all day). On 01-May-2021, PAIN IN EXTREMITY (arm was hurting really bad) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (shortness of breath, smoker but hasn't been smoking), SECRETION DISCHARGE (more and more mucous), COUGH (Coughing), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), CHILLS (Chills), HEADACHE (Headache) and VOMITING (splitting up all day) 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.   Concomitant  Rheumatoid Arthritis Medications   Treatment Cough Drops Cough Syrup Cold Shower
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity, Secretion discharge, Vomiting
Clinical narrative: flu like symptoms; shortness of breath, smoker but hasn't been smoking; more and more mucous; Coughing; cold and hot; Chills; Headache; splitting up all day; arm was hurting really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting really bad), INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (shortness of breath, smoker but hasn't been smoking), SECRETION DISCHARGE (more and more mucous) and COUGH (Coughing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting really bad). On 01-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (shortness of breath, smoker but hasn't been smoking), SECRETION DISCHARGE (more and more mucous), COUGH (Coughing), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), CHILLS (Chills), HEADACHE (Headache) and VOMITING (splitting up all day). On 01-May-2021, PAIN IN EXTREMITY (arm was hurting really bad) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DYSPNOEA (shortness of breath, smoker but hasn't been smoking), SECRETION DISCHARGE (more and more mucous), COUGH (Coughing), FEELING OF BODY TEMPERATURE CHANGE (cold and hot), CHILLS (Chills), HEADACHE (Headache) and VOMITING (splitting up all day) 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.   Concomitant  Rheumatoid Arthritis Medications   Treatment Cough Drops Cough Syrup Cold Shower
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Sore Arm; fatigue; Chills; Headache; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arm), FATIGUE (fatigue), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (Sore Arm), FATIGUE (fatigue), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-May-2021, MYALGIA (Sore Arm), FATIGUE (fatigue), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient was taking concomitant medication but information was not provided. No treatment information was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sore Arm; fatigue; Chills; Headache; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arm), FATIGUE (fatigue), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (Sore Arm), FATIGUE (fatigue), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-May-2021, MYALGIA (Sore Arm), FATIGUE (fatigue), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient was taking concomitant medication but information was not provided. No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chronic obstructive pulmonary disease, Cough, Dyspnoea, Myalgia
Clinical narrative: COPD flareup; Symptoms of coughing; Trouble breathing; knee pain; Experienced body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD flareup), COUGH (Symptoms of coughing), DYSPNOEA (Trouble breathing), ARTHRALGIA (knee pain) and MYALGIA (Experienced body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (left knee replacement in 2015) in 2015.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD flareup), COUGH (Symptoms of coughing), DYSPNOEA (Trouble breathing), ARTHRALGIA (knee pain) and MYALGIA (Experienced body aches). The patient was treated with HYDROMORPHONE at a dose of 2 mg and CORTISONE at an unspecified dose and frequency. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD flareup), COUGH (Symptoms of coughing), DYSPNOEA (Trouble breathing), ARTHRALGIA (knee pain) and MYALGIA (Experienced body aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information  provided was Corticosteroids.  The action taken with mRNA-1273 with the events was considered as not applicable  For mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-114424 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Insomnia, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever / Highest temperature was 103 degrees / Staying 100 degrees to 103 degrees), CHILLS (Chills), HEADACHE (Headaches), PAIN (Body aches) and INSOMNIA (Unable to sleep for 2 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and Lot # 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021 at 9:00 PM, the patient experienced PYREXIA (Fever / Highest temperature was 103 degrees / Staying 100 degrees to 103 degrees), CHILLS (Chills), HEADACHE (Headaches), PAIN (Body aches) and INSOMNIA (Unable to sleep for 2 days). At the time of the report, PYREXIA (Fever / Highest temperature was 103 degrees / Staying 100 degrees to 103 degrees), CHILLS (Chills), HEADACHE (Headaches), PAIN (Body aches) and INSOMNIA (Unable to sleep for 2 days) had not resolved. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) Staying 100 degrees to 103 degrees. The patient stated she would not like to receive Moderna vaccine again. She spoke to her doctor about her symptoms, they are still persisting. Concomitant medications have no been reported. No treatment for the events.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever / Highest temperature was 103 degrees / Staying 100 degrees to 103 degrees), CHILLS (Chills), HEADACHE (Headaches), PAIN (Body aches) and INSOMNIA (Unable to sleep for 2 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and Lot # 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021 at 9:00 PM, the patient experienced PYREXIA (Fever / Highest temperature was 103 degrees / Staying 100 degrees to 103 degrees), CHILLS (Chills), HEADACHE (Headaches), PAIN (Body aches) and INSOMNIA (Unable to sleep for 2 days). At the time of the report, PYREXIA (Fever / Highest temperature was 103 degrees / Staying 100 degrees to 103 degrees), CHILLS (Chills), HEADACHE (Headaches), PAIN (Body aches) and INSOMNIA (Unable to sleep for 2 days) had not resolved. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) Staying 100 degrees to 103 degrees. The patient stated she would not like to receive Moderna vaccine again. She spoke to her doctor about her symptoms, they are still persisting. Concomitant medications have no been reported. No treatment for the events.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick) 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 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced ILLNESS (Really sick). At the time of the report, ILLNESS (Really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that they were really sick with the first dose. The patient was planning on getting the second dose which was scheduled for 26-May-2021. The patient also informed that they expected to get sick post vaccination because the patient gets sick after they receive a flu shot.  No Concomitant product use was reported. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Joint swelling, Limb injury, Overdose, Pain
Clinical narrative: Has not received her 2nd dose; Arthritis is 10 times worse; Joints blew up; Fingertips blew up like a little balloon; Her toe broke open; It was bad; May have received "too much" of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (May have received "too much" of the vaccine), PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose), ARTHRITIS (Arthritis is 10 times worse), JOINT SWELLING (Joints blew up) and PERIPHERAL SWELLING (Fingertips blew up like a little balloon) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Pneumonia: PNEUMO 23; for Flu: FLU VACCINE VII. Concurrent medical conditions included Type 1 diabetes mellitus and Rheumatoid arthritis. Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced OVERDOSE (May have received "too much" of the vaccine), ARTHRITIS (Arthritis is 10 times worse), JOINT SWELLING (Joints blew up), PERIPHERAL SWELLING (Fingertips blew up like a little balloon), LIMB INJURY (Her toe broke open) and PAIN (It was bad). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 24-Feb-2021, OVERDOSE (May have received "too much" of the vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose) had resolved and ARTHRITIS (Arthritis is 10 times worse), JOINT SWELLING (Joints blew up), PERIPHERAL SWELLING (Fingertips blew up like a little balloon), LIMB INJURY (Her toe broke open) and PAIN (It was bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Product dose omission issue
Clinical narrative: Has not received her 2nd dose; Arthritis is 10 times worse; Joints blew up; Fingertips blew up like a little balloon; Her toe broke open; It was bad; May have received "too much" of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (May have received "too much" of the vaccine), PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose), ARTHRITIS (Arthritis is 10 times worse), JOINT SWELLING (Joints blew up) and PERIPHERAL SWELLING (Fingertips blew up like a little balloon) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Pneumonia: PNEUMO 23; for Flu: FLU VACCINE VII. Concurrent medical conditions included Type 1 diabetes mellitus and Rheumatoid arthritis. Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced OVERDOSE (May have received "too much" of the vaccine), ARTHRITIS (Arthritis is 10 times worse), JOINT SWELLING (Joints blew up), PERIPHERAL SWELLING (Fingertips blew up like a little balloon), LIMB INJURY (Her toe broke open) and PAIN (It was bad). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 24-Feb-2021, OVERDOSE (May have received "too much" of the vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received her 2nd dose) had resolved and ARTHRITIS (Arthritis is 10 times worse), JOINT SWELLING (Joints blew up), PERIPHERAL SWELLING (Fingertips blew up like a little balloon), LIMB INJURY (Her toe broke open) and PAIN (It was bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for the coronavirus; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested positive for the coronavirus) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced COVID-19 (Patient tested positive for the coronavirus). At the time of the report, COVID-19 (Patient tested positive for the coronavirus) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, SARS-CoV-2 test: (Positive) positive.     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.   No concomitant medications were reported.No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Extra dose administered, Fatigue, Gait disturbance, Malaise
Clinical narrative: still fatigued; a little nauseous; temperature was 99.8; vomiting; third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose; malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),; hard to climb stairs; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose), MALAISE (malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),), GAIT DISTURBANCE (hard to climb stairs), PYREXIA (temperature was 99.8) and VOMITING (vomiting) in a female patient of an unknown age 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 04-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose), MALAISE (malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),) and GAIT DISTURBANCE (hard to climb stairs). On 05-May-2021, the patient experienced PYREXIA (temperature was 99.8) and VOMITING (vomiting). On 06-May-2021, the patient experienced FATIGUE (still fatigued) and NAUSEA (a little nauseous). On 05-May-2021, VOMITING (vomiting) had resolved. On 06-May-2021, PYREXIA (temperature was 99.8) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose) had resolved and MALAISE (malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),), GAIT DISTURBANCE (hard to climb stairs), FATIGUE (still fatigued) and NAUSEA (a little nauseous) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (High) temperature-99.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       This case was linked to MOD-2021-044878, MOD-2021-044878 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: still fatigued; a little nauseous; temperature was 99.8; vomiting; third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose; malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),; hard to climb stairs; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose), MALAISE (malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),), GAIT DISTURBANCE (hard to climb stairs), PYREXIA (temperature was 99.8) and VOMITING (vomiting) in a female patient of an unknown age 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 04-May-2021, the patient experienced EXTRA DOSE ADMINISTERED (third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose), MALAISE (malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),) and GAIT DISTURBANCE (hard to climb stairs). On 05-May-2021, the patient experienced PYREXIA (temperature was 99.8) and VOMITING (vomiting). On 06-May-2021, the patient experienced FATIGUE (still fatigued) and NAUSEA (a little nauseous). On 05-May-2021, VOMITING (vomiting) had resolved. On 06-May-2021, PYREXIA (temperature was 99.8) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (third dose was given on 4 May 2021 (Moderna) at a vaccine site after 07APR2021 second Dose) had resolved and MALAISE (malaise about 7 hours after the shot (verbatim: felt like she got hit by a 10-ton truck),), GAIT DISTURBANCE (hard to climb stairs), FATIGUE (still fatigued) and NAUSEA (a little nauseous) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (High) temperature-99.8.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       This case was linked to MOD-2021-044878, MOD-2021-044878 (Patient Link).   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Vaccination site pain
Clinical narrative: slight soreness on right side of throat/slight soreness on right side of throat when swallowing; soreness in their arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (slight soreness on right side of throat/slight soreness on right side of throat when swallowing) and VACCINATION SITE PAIN (soreness in their arm at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014-M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (slight soreness on right side of throat/slight soreness on right side of throat when swallowing) and VACCINATION SITE PAIN (soreness in their arm at the injection site). On 14-Apr-2021, OROPHARYNGEAL PAIN (slight soreness on right side of throat/slight soreness on right side of throat when swallowing) and VACCINATION SITE PAIN (soreness in their arm at the injection site) had resolved.        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.   No concomitant medications provided. Treatment included Motrin and a arm rub
Age: 60.0
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 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037D21A and 038821A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (diarrhea). On 20-Apr-2021, DIARRHOEA (diarrhea) had resolved.      No concomitant medication was provided. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114380 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114380:Dose 1 case
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: First dose was with the Moderna Covid-19 vaccine and the second dose was with the Pfizer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (First dose was with the Moderna Covid-19 vaccine and the second dose was with the Pfizer) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (First dose was with the Moderna Covid-19 vaccine and the second dose was with the Pfizer). On 07-May-2021, PRODUCT ADMINISTRATION ERROR (First dose was with the Moderna Covid-19 vaccine and the second dose was with the Pfizer) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-127528 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127528:Case for patient 1
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Rash, Rash pruritic
Clinical narrative: Rash so bad, he could not sleep/ Itches a little bit but it does not severely; Rash so bad, he could not sleep; Rash going up his leg/ Rash going up his leg/ Rash going up his back/ Rash looks like chickenpox; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash so bad, he could not sleep/ Itches a little bit but it does not severely), INSOMNIA (Rash so bad, he could not sleep) and RASH (Rash going up his leg/ Rash going up his leg/ Rash going up his back/ Rash looks like chickenpox) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced INSOMNIA (Rash so bad, he could not sleep) and RASH (Rash going up his leg/ Rash going up his leg/ Rash going up his back/ Rash looks like chickenpox). On an unknown date, the patient experienced RASH PRURITIC (Rash so bad, he could not sleep/ Itches a little bit but it does not severely). At the time of the report, RASH PRURITIC (Rash so bad, he could not sleep/ Itches a little bit but it does not severely), INSOMNIA (Rash so bad, he could not sleep) and RASH (Rash going up his leg/ Rash going up his leg/ Rash going up his back/ Rash looks like chickenpox) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment medication include Banophen 25 m and Mupirocin ointment USP 2%  .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.     This case was linked to MOD-2021-114468 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Constipation; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-May-2021 and was forwarded to Moderna on 07-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation) in a patient of an unknown age and 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Constipation). At the time of the report, CONSTIPATION (Constipation) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Received an expired vaccine; Vaccine administered from a vial that was 1st punctured on 7May2021 at 4:38PM and left out at room temperature; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered from a vial that was 1st punctured on 7May2021 at 4:38PM and left out at room temperature) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included ETANERCEPT (ENBREL), METHOTREXATE, FAMOTIDINE and FOLIC ACID for an unknown indication.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered from a vial that was 1st punctured on 7May2021 at 4:38PM and left out at room temperature). On 08-May-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered from a vial that was 1st punctured on 7May2021 at 4:38PM and left out at room temperature) 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.   Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: New event temperature excursion of vaccine updated. On 11-May-2021: Follow-up contains NNI
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: soreness at injection site; pain; swollen arm; itching; headache; could not sleep on side; injection site is hot; fever of 102 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site), PAIN (pain), PERIPHERAL SWELLING (swollen arm), PRURITUS (itching) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TOPIRAMATE and CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site), PAIN (pain), PERIPHERAL SWELLING (swollen arm), PRURITUS (itching), HEADACHE (headache), SLEEP DISORDER (could not sleep on side), VACCINATION SITE WARMTH (injection site is hot) and PYREXIA (fever of 102 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at injection site), PAIN (pain), PERIPHERAL SWELLING (swollen arm), PRURITUS (itching), HEADACHE (headache), SLEEP DISORDER (could not sleep on side), VACCINATION SITE WARMTH (injection site is hot) and PYREXIA (fever of 102 degrees Fahrenheit) 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site pain, Vaccination site warmth
Clinical narrative: soreness at injection site; pain; swollen arm; itching; headache; could not sleep on side; injection site is hot; fever of 102 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site), PAIN (pain), PERIPHERAL SWELLING (swollen arm), PRURITUS (itching) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TOPIRAMATE and CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site), PAIN (pain), PERIPHERAL SWELLING (swollen arm), PRURITUS (itching), HEADACHE (headache), SLEEP DISORDER (could not sleep on side), VACCINATION SITE WARMTH (injection site is hot) and PYREXIA (fever of 102 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at injection site), PAIN (pain), PERIPHERAL SWELLING (swollen arm), PRURITUS (itching), HEADACHE (headache), SLEEP DISORDER (could not sleep on side), VACCINATION SITE WARMTH (injection site is hot) and PYREXIA (fever of 102 degrees Fahrenheit) 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.