chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Severe reaction to the vaccination; More than one nose bleed; Developed swelling under jaw line; Swelling under neck felt like it was on fire; Felt like I had something under one arm; Too sick to do anything; Short of breath; Immediately became freezing; Developed a horrible headache; Very tired; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Severe reaction to the vaccination), EPISTAXIS (More than one nose bleed), SWELLING FACE (Developed swelling under jaw line), SWELLING (Swelling under neck felt like it was on fire) and LIMB DISCOMFORT (Felt like I had something under one arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Never officially tested. ) in July 2020. Previously administered products included for an unreported indication: FLU VACCINE VII (has it every year). Concomitant products included BUDESONIDE for Allergy, ESTRADIOL for Hormone therapy, LEVOTHYROXINE for Hypothyroidism, CETIRIZINE HYDROCHLORIDE (ZYRTEC R).    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE REACTION (Severe reaction to the vaccination), EPISTAXIS (More than one nose bleed), SWELLING FACE (Developed swelling under jaw line), SWELLING (Swelling under neck felt like it was on fire), LIMB DISCOMFORT (Felt like I had something under one arm), ILLNESS (Too sick to do anything), DYSPNOEA (Short of breath), CHILLS (Immediately became freezing), HEADACHE (Developed a horrible headache), FATIGUE (Very tired) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION SITE REACTION (Severe reaction to the vaccination), EPISTAXIS (More than one nose bleed), SWELLING FACE (Developed swelling under jaw line), SWELLING (Swelling under neck felt like it was on fire), LIMB DISCOMFORT (Felt like I had something under one arm), ILLNESS (Too sick to do anything), DYSPNOEA (Short of breath), CHILLS (Immediately became freezing), FATIGUE (Very tired) and ARTHRALGIA (Joint pain) was resolving and HEADACHE (Developed a horrible headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included caffeine and paracetamol for headache.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 16-Jan-2021, PAIN IN EXTREMITY (arm pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-033496 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Dry mouth
Clinical narrative: sickness; haemorrhoids; tremor; felt bad; cold flashes; tired and worn out; felt like she is going to throw up; blood present when she blew her nose; diarrhea; hot and cold flashes; really weak; Dry mouth; lots of mucus; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak) and DRY MOUTH (Dry mouth) in a 70-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.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation vapour, tablet for Pulmonary arterial hypertension.    The patient's past medical history included Tremor. Concurrent medical conditions included Primary pulmonary hypertension (primary pulmonary arterial hypertension). Concomitant products included RIOCIGUAT (ADEMPAS), APIXABAN (ELIQUIS) and AMLODIPINE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose 1. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose 2. On an unknown date, the patient started TREPROSTINIL SODIUM (Nasal) at an unspecified dose once a day. In April 2021, the patient experienced EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak), DRY MOUTH (Dry mouth), SECRETION DISCHARGE (lots of mucus), DECREASED APPETITE (no appetite), FEELING ABNORMAL (felt bad), CHILLS (cold flashes), FATIGUE (tired and worn out) and NAUSEA (felt like she is going to throw up). On an unknown date, the patient experienced TREMOR (tremor), ILLNESS (sickness) and HAEMORRHOIDS (haemorrhoids). At the time of the report, EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak), DRY MOUTH (Dry mouth), SECRETION DISCHARGE (lots of mucus), DECREASED APPETITE (no appetite), TREMOR (tremor), FEELING ABNORMAL (felt bad), ILLNESS (sickness), HAEMORRHOIDS (haemorrhoids), CHILLS (cold flashes), FATIGUE (tired and worn out) and NAUSEA (felt like she is going to throw up) outcome was unknown.            This case was linked to MOD-2021-074797 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Epistaxis, Fatigue, Feeling abnormal, Haemorrhoids, Hot flush
Clinical narrative: sickness; haemorrhoids; tremor; felt bad; cold flashes; tired and worn out; felt like she is going to throw up; blood present when she blew her nose; diarrhea; hot and cold flashes; really weak; Dry mouth; lots of mucus; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak) and DRY MOUTH (Dry mouth) in a 70-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.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation vapour, tablet for Pulmonary arterial hypertension.    The patient's past medical history included Tremor. Concurrent medical conditions included Primary pulmonary hypertension (primary pulmonary arterial hypertension). Concomitant products included RIOCIGUAT (ADEMPAS), APIXABAN (ELIQUIS) and AMLODIPINE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose 1. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose 2. On an unknown date, the patient started TREPROSTINIL SODIUM (Nasal) at an unspecified dose once a day. In April 2021, the patient experienced EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak), DRY MOUTH (Dry mouth), SECRETION DISCHARGE (lots of mucus), DECREASED APPETITE (no appetite), FEELING ABNORMAL (felt bad), CHILLS (cold flashes), FATIGUE (tired and worn out) and NAUSEA (felt like she is going to throw up). On an unknown date, the patient experienced TREMOR (tremor), ILLNESS (sickness) and HAEMORRHOIDS (haemorrhoids). At the time of the report, EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak), DRY MOUTH (Dry mouth), SECRETION DISCHARGE (lots of mucus), DECREASED APPETITE (no appetite), TREMOR (tremor), FEELING ABNORMAL (felt bad), ILLNESS (sickness), HAEMORRHOIDS (haemorrhoids), CHILLS (cold flashes), FATIGUE (tired and worn out) and NAUSEA (felt like she is going to throw up) outcome was unknown.            This case was linked to MOD-2021-074797 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Nausea, Secretion discharge, Tremor
Clinical narrative: sickness; haemorrhoids; tremor; felt bad; cold flashes; tired and worn out; felt like she is going to throw up; blood present when she blew her nose; diarrhea; hot and cold flashes; really weak; Dry mouth; lots of mucus; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak) and DRY MOUTH (Dry mouth) in a 70-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.    Co-suspect product included non-company product TREPROSTINIL SODIUM inhalation vapour, tablet for Pulmonary arterial hypertension.    The patient's past medical history included Tremor. Concurrent medical conditions included Primary pulmonary hypertension (primary pulmonary arterial hypertension). Concomitant products included RIOCIGUAT (ADEMPAS), APIXABAN (ELIQUIS) and AMLODIPINE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Dose 1. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to Dose 2. On an unknown date, the patient started TREPROSTINIL SODIUM (Nasal) at an unspecified dose once a day. In April 2021, the patient experienced EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak), DRY MOUTH (Dry mouth), SECRETION DISCHARGE (lots of mucus), DECREASED APPETITE (no appetite), FEELING ABNORMAL (felt bad), CHILLS (cold flashes), FATIGUE (tired and worn out) and NAUSEA (felt like she is going to throw up). On an unknown date, the patient experienced TREMOR (tremor), ILLNESS (sickness) and HAEMORRHOIDS (haemorrhoids). At the time of the report, EPISTAXIS (blood present when she blew her nose), DIARRHOEA (diarrhea), HOT FLUSH (hot and cold flashes), ASTHENIA (really weak), DRY MOUTH (Dry mouth), SECRETION DISCHARGE (lots of mucus), DECREASED APPETITE (no appetite), TREMOR (tremor), FEELING ABNORMAL (felt bad), ILLNESS (sickness), HAEMORRHOIDS (haemorrhoids), CHILLS (cold flashes), FATIGUE (tired and worn out) and NAUSEA (felt like she is going to throw up) outcome was unknown.            This case was linked to MOD-2021-074797 (Patient Link).
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Headache, Nasal discomfort, Nausea
Clinical narrative: Lightheadedness; Fever; Pain behind eyes; Pain behind nose; Pain behind forehead; when he turns his head he gets dizzy and then feels nauseous; when he turns his head he gets dizzy and then feels nauseous; Headache; had a little soreness in the arm; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a little soreness in the arm), HEADACHE (Headache), DIZZINESS (Dizziness), DIZZINESS (Lightheadedness) and PYREXIA (Fever) in a 50-year-old patient of an unknown gender 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.     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 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (had a little soreness in the arm). On 23-Apr-2021, the patient experienced HEADACHE (Headache), DIZZINESS (Lightheadedness), PYREXIA (Fever), EYE PAIN (Pain behind eyes), NASAL DISCOMFORT (Pain behind nose), HEADACHE (Pain behind forehead), DIZZINESS (when he turns his head he gets dizzy and then feels nauseous) and NAUSEA (when he turns his head he gets dizzy and then feels nauseous). At the time of the report, VACCINATION SITE PAIN (had a little soreness in the arm), HEADACHE (Headache), DIZZINESS (Dizziness), DIZZINESS (Lightheadedness), PYREXIA (Fever), EYE PAIN (Pain behind eyes), NASAL DISCOMFORT (Pain behind nose), HEADACHE (Pain behind forehead), DIZZINESS (when he turns his head he gets dizzy and then feels nauseous) and NAUSEA (when he turns his head he gets dizzy and then feels nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Lightheadedness; Fever; Pain behind eyes; Pain behind nose; Pain behind forehead; when he turns his head he gets dizzy and then feels nauseous; when he turns his head he gets dizzy and then feels nauseous; Headache; had a little soreness in the arm; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a little soreness in the arm), HEADACHE (Headache), DIZZINESS (Dizziness), DIZZINESS (Lightheadedness) and PYREXIA (Fever) in a 50-year-old patient of an unknown gender 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.     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 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizziness). On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (had a little soreness in the arm). On 23-Apr-2021, the patient experienced HEADACHE (Headache), DIZZINESS (Lightheadedness), PYREXIA (Fever), EYE PAIN (Pain behind eyes), NASAL DISCOMFORT (Pain behind nose), HEADACHE (Pain behind forehead), DIZZINESS (when he turns his head he gets dizzy and then feels nauseous) and NAUSEA (when he turns his head he gets dizzy and then feels nauseous). At the time of the report, VACCINATION SITE PAIN (had a little soreness in the arm), HEADACHE (Headache), DIZZINESS (Dizziness), DIZZINESS (Lightheadedness), PYREXIA (Fever), EYE PAIN (Pain behind eyes), NASAL DISCOMFORT (Pain behind nose), HEADACHE (Pain behind forehead), DIZZINESS (when he turns his head he gets dizzy and then feels nauseous) and NAUSEA (when he turns his head he gets dizzy and then feels nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: sore injection site right arm; did not receive second vaccine dose within 35 days of first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site right arm) and PRODUCT DOSE OMISSION ISSUE (did not receive second vaccine dose within 35 days of first dose) 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 22-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 VACCINATION SITE PAIN (sore injection site right arm) and PRODUCT DOSE OMISSION ISSUE (did not receive second vaccine dose within 35 days of first dose). At the time of the report, VACCINATION SITE PAIN (sore injection site right arm) and PRODUCT DOSE OMISSION ISSUE (did not receive second vaccine dose within 35 days of first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Mobility decreased
Clinical narrative: lost the use of legs; was able to walk a little bit; 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 MOBILITY DECREASED (lost the use of legs) and GAIT DISTURBANCE (was able to walk a little bit) 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 30-Mar-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 MOBILITY DECREASED (lost the use of legs) and GAIT DISTURBANCE (was able to walk a little bit). At the time of the report, MOBILITY DECREASED (lost the use of legs) and GAIT DISTURBANCE (was able to walk a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Muscle spasms
Clinical narrative: muscle cramps and aches; Dizziness; overall just don't feel good.; fatigue; headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of MUSCLE SPASMS (muscle cramps and aches), DIZZINESS (Dizziness), FEELING ABNORMAL (overall just don't feel good.), FATIGUE (fatigue) and HEADACHE (headaches) 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 MUSCLE SPASMS (muscle cramps and aches), DIZZINESS (Dizziness), FEELING ABNORMAL (overall just don't feel good.), FATIGUE (fatigue) and HEADACHE (headaches). At the time of the report, MUSCLE SPASMS (muscle cramps and aches), DIZZINESS (Dizziness), FEELING ABNORMAL (overall just don't feel good.), FATIGUE (fatigue) and HEADACHE (headaches) 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.   Concomitant medication information was not reported. Treatment information as not reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Illness, Pain, Vaccination site mass
Clinical narrative: lot of pain and it took 2 canes for her to walk; lot of pain and it took 2 canes for her to walk; get sick and go to bed; Knot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (lot of pain and it took 2 canes for her to walk), GAIT DISTURBANCE (lot of pain and it took 2 canes for her to walk), ILLNESS (get sick and go to bed) and VACCINATION SITE MASS (Knot) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Eczema.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (lot of pain and it took 2 canes for her to walk), GAIT DISTURBANCE (lot of pain and it took 2 canes for her to walk), ILLNESS (get sick and go to bed) and VACCINATION SITE MASS (Knot). At the time of the report, PAIN (lot of pain and it took 2 canes for her to walk), GAIT DISTURBANCE (lot of pain and it took 2 canes for her to walk), ILLNESS (get sick and go to bed) and VACCINATION SITE MASS (Knot) outcome was unknown.            relevant concomitant products usage were not reported by the reporter. Treatment details not included.   This case was linked to MOD-2021-040697 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; 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 FATIGUE (Tired) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired). At the time of the report, FATIGUE (Tired) outcome was unknown.            Concomitant product details was not reported.  Treatment details was not reported .     This case was linked to MOD-2021-104792 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Arm bother her extremely bad; low fever; Low mild headache; Tired; Tested covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm bother her extremely bad), SARS-COV-2 TEST POSITIVE (Tested covid-19 positive), PYREXIA (low fever), HEADACHE (Low mild headache) and FATIGUE (Tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested covid-19 positive). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm bother her extremely bad), PYREXIA (low fever), HEADACHE (Low mild headache) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm bother her extremely bad), SARS-COV-2 TEST POSITIVE (Tested covid-19 positive), PYREXIA (low fever), HEADACHE (Low mild headache) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, SARS-CoV-2 antibody test: positive (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.   Concomitant products details not provided. Treatment details not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Arm bother her extremely bad; low fever; Low mild headache; Tired; Tested covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm bother her extremely bad), SARS-COV-2 TEST POSITIVE (Tested covid-19 positive), PYREXIA (low fever), HEADACHE (Low mild headache) and FATIGUE (Tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested covid-19 positive). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm bother her extremely bad), PYREXIA (low fever), HEADACHE (Low mild headache) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm bother her extremely bad), SARS-COV-2 TEST POSITIVE (Tested covid-19 positive), PYREXIA (low fever), HEADACHE (Low mild headache) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, SARS-CoV-2 antibody test: positive (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.   Concomitant products details not provided. Treatment details not provided.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Oropharyngeal pain, Pulmonary pain
Clinical narrative: body aches similar like the flu; sore throat; lungs hurt when she takes a deep breath; body aches similar like the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu) 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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu). At the time of the report, INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-106569 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106569:second dose
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: inflamed,hard; sick to her stomach; injection arm, there is a red mark, and it is inflamed and hard.; chills; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflamed,hard), ABDOMINAL DISCOMFORT (sick to her stomach), VACCINATION SITE ERYTHEMA (injection arm, there is a red mark, and it is inflamed and hard.), CHILLS (chills) and HEADACHE (slight headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 INFLAMMATION (inflamed,hard), ABDOMINAL DISCOMFORT (sick to her stomach), VACCINATION SITE ERYTHEMA (injection arm, there is a red mark, and it is inflamed and hard.), CHILLS (chills) and HEADACHE (slight headache). At the time of the report, VACCINATION SITE INFLAMMATION (inflamed,hard), ABDOMINAL DISCOMFORT (sick to her stomach), VACCINATION SITE ERYTHEMA (injection arm, there is a red mark, and it is inflamed and hard.), CHILLS (chills) and HEADACHE (slight headache) 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Herpes zoster, Lethargy, Paraesthesia, Rash
Clinical narrative: shingles; lethargic; tingling in right leg; Just a weird feeling in my right leg; rash developed on my leg right thigh buttocks; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PARAESTHESIA (tingling in right leg), FEELING ABNORMAL (Just a weird feeling in my right leg), RASH (rash developed on my leg right thigh buttocks) and HERPES ZOSTER (shingles) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported ).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced LETHARGY (lethargic), PARAESTHESIA (tingling in right leg), FEELING ABNORMAL (Just a weird feeling in my right leg) and RASH (rash developed on my leg right thigh buttocks). On 03-May-2021, the patient experienced HERPES ZOSTER (shingles). The patient was treated with FAMCICLOVIR  500MG three times a day . At the time of the report, LETHARGY (lethargic), PARAESTHESIA (tingling in right leg), FEELING ABNORMAL (Just a weird feeling in my right leg), RASH (rash developed on my leg right thigh buttocks) and HERPES ZOSTER (shingles) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Illness, Malaise
Clinical narrative: was sick for 3 weeks and 2 days after the vaccine; fever; Head congestion; Woke up the next day not feeling well; Fatigue; Upper chest congestion; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Upper chest congestion), OROPHARYNGEAL PAIN (Sore throat), ILLNESS (was sick for 3 weeks and 2 days after the vaccine), MALAISE (Woke up the next day not feeling well) and FATIGUE (Fatigue) in a 36-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.     The patient's past medical history included COVID-19 (The Caller reported that her son had COVID in September/October one month after moving to another city).    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced RESPIRATORY TRACT CONGESTION (Upper chest congestion), OROPHARYNGEAL PAIN (Sore throat), MALAISE (Woke up the next day not feeling well), FATIGUE (Fatigue) and HEADACHE (Head congestion). On 27-Apr-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced ILLNESS (was sick for 3 weeks and 2 days after the vaccine). On 03-May-2021, RESPIRATORY TRACT CONGESTION (Upper chest congestion), OROPHARYNGEAL PAIN (Sore throat), MALAISE (Woke up the next day not feeling well), FATIGUE (Fatigue), PYREXIA (fever) and HEADACHE (Head congestion) had resolved. At the time of the report, ILLNESS (was sick for 3 weeks and 2 days after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 99.5-100 degree f The patient got a fever that ranged from 99.5-100.2 degrees F.     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 medications reported.  The patient got an antibiotic to relieve the symptoms.  Action taken with mRNA-1273 in response to the event was unknown
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: was sick for 3 weeks and 2 days after the vaccine; fever; Head congestion; Woke up the next day not feeling well; Fatigue; Upper chest congestion; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Upper chest congestion), OROPHARYNGEAL PAIN (Sore throat), ILLNESS (was sick for 3 weeks and 2 days after the vaccine), MALAISE (Woke up the next day not feeling well) and FATIGUE (Fatigue) in a 36-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.     The patient's past medical history included COVID-19 (The Caller reported that her son had COVID in September/October one month after moving to another city).    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced RESPIRATORY TRACT CONGESTION (Upper chest congestion), OROPHARYNGEAL PAIN (Sore throat), MALAISE (Woke up the next day not feeling well), FATIGUE (Fatigue) and HEADACHE (Head congestion). On 27-Apr-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced ILLNESS (was sick for 3 weeks and 2 days after the vaccine). On 03-May-2021, RESPIRATORY TRACT CONGESTION (Upper chest congestion), OROPHARYNGEAL PAIN (Sore throat), MALAISE (Woke up the next day not feeling well), FATIGUE (Fatigue), PYREXIA (fever) and HEADACHE (Head congestion) had resolved. At the time of the report, ILLNESS (was sick for 3 weeks and 2 days after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 99.5-100 degree f The patient got a fever that ranged from 99.5-100.2 degrees F.     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 medications reported.  The patient got an antibiotic to relieve the symptoms.  Action taken with mRNA-1273 in response to the event was unknown
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative, SARS-CoV-2 test
Clinical narrative: Tested negative; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Tested negative) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Tested negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Tested negative) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.         Other concomitant medications include Blood pressure and cholesterol medications (not specified) No treatment details were provided.  Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to US-MODERNATX, INC.-MOD-2021-106786 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106786:Case for wife
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia, Tinnitus
Clinical narrative: she experience ringing in her ears, worse then ever before, states she has had ringing in the ears prior to ever receiving the Moderna vaccine but says it was worse then ever; Had a temperature which lasted for 48 hours; Felt off; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt off), TINNITUS (she experience ringing in her ears, worse then ever before, states she has had ringing in the ears prior to ever receiving the Moderna vaccine but says it was worse then ever) and PYREXIA (Had a temperature which lasted for 48 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Aspirin,), Drug allergy (cough syrup) and Drug allergy (codeine). Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 13-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 FEELING ABNORMAL (Felt off) and PYREXIA (Had a temperature which lasted for 48 hours). On 14-Apr-2021, the patient experienced TINNITUS (she experience ringing in her ears, worse then ever before, states she has had ringing in the ears prior to ever receiving the Moderna vaccine but says it was worse then ever). On 15-Apr-2021, PYREXIA (Had a temperature which lasted for 48 hours) had resolved. At the time of the report, FEELING ABNORMAL (Felt off) had resolved and TINNITUS (she experience ringing in her ears, worse then ever before, states she has had ringing in the ears prior to ever receiving the Moderna vaccine but says it was worse then ever) had not 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.   Treatment  was "white noise machine to help" for the symptom to recede, as reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received on 10-jun-2021 includes patient demographic details and medical history was added out come of the event was updated
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches). At the time of the report, PAIN (Body aches) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-044885 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-044885:First dose case
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Developed shingles) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 HERPES ZOSTER (Developed shingles). At the time of the report, HERPES ZOSTER (Developed shingles) 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.   No concomitant and treatment medications were provided
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb deformity, Vaccination site swelling
Clinical narrative: vaccination site swelling; Not able to extent her arm more than 90 degree; Painful right elbow; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (vaccination site swelling), LIMB DEFORMITY (Not able to extent her arm more than 90 degree) and ARTHRALGIA (Painful right elbow) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling), LIMB DEFORMITY (Not able to extent her arm more than 90 degree) and ARTHRALGIA (Painful right elbow). At the time of the report, VACCINATION SITE SWELLING (vaccination site swelling), LIMB DEFORMITY (Not able to extent her arm more than 90 degree) and ARTHRALGIA (Painful right elbow) 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.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Coagulopathy, Computerised tomogram
Clinical narrative: pain in my right lung; Pleurisy; blood clot; difficulty breathing; body aches; chills; low grade fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLEURISY (Pleurisy), COAGULOPATHY (blood clot), DYSPNOEA (difficulty breathing), PULMONARY PAIN (pain in my right lung) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Supraventricular tachycardia on 04-Apr-2017 and AFib since 04-Apr-2017. Concomitant products included VERAPAMIL from 04-May-2017 to an unknown date, ACETYLSALICYLIC ACID (ASPIRIN BAYER) from 07-Jan-2003 to an unknown date and TAMSULOSIN HYDROCHLORIDE (FLOWMAX) from 14-Oct-2012 to an unknown date for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and PYREXIA (low grade fever). On 02-May-2021, the patient experienced DYSPNOEA (difficulty breathing). On 05-May-2021, the patient experienced PLEURISY (Pleurisy), COAGULOPATHY (blood clot) and PULMONARY PAIN (pain in my right lung). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) for Pleurisy, at a dose of 875 mg twice a day. On 15-May-2021, PLEURISY (Pleurisy), COAGULOPATHY (blood clot), DYSPNOEA (difficulty breathing), PULMONARY PAIN (pain in my right lung) and MYALGIA (body aches) had resolved. At the time of the report, CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100.4 degree (High) 100.4 degree F. On 04-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 05-May-2021, Blood test: abnormal (abnormal) D-dimer was elevated to 3600, Possible blood clot. On 05-May-2021, Computerised tomogram: abnormal (abnormal) Developed Pleurisy.         Symptoms: Patient reported that he had spiked fever and Difficulty breathing after vaccination.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-103195, MOD-2021-103270 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains Significant information: Added Patient Demographics, Medical History, Lab Data, Suspect Drug Information, Concomitant medications, Treatment Medication, New Events added, Event outcome added.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Myalgia, Pleurisy, Pulmonary pain, Pyrexia
Clinical narrative: pain in my right lung; Pleurisy; blood clot; difficulty breathing; body aches; chills; low grade fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PLEURISY (Pleurisy), COAGULOPATHY (blood clot), DYSPNOEA (difficulty breathing), PULMONARY PAIN (pain in my right lung) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Supraventricular tachycardia on 04-Apr-2017 and AFib since 04-Apr-2017. Concomitant products included VERAPAMIL from 04-May-2017 to an unknown date, ACETYLSALICYLIC ACID (ASPIRIN BAYER) from 07-Jan-2003 to an unknown date and TAMSULOSIN HYDROCHLORIDE (FLOWMAX) from 14-Oct-2012 to an unknown date for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (body aches), CHILLS (chills) and PYREXIA (low grade fever). On 02-May-2021, the patient experienced DYSPNOEA (difficulty breathing). On 05-May-2021, the patient experienced PLEURISY (Pleurisy), COAGULOPATHY (blood clot) and PULMONARY PAIN (pain in my right lung). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) for Pleurisy, at a dose of 875 mg twice a day. On 15-May-2021, PLEURISY (Pleurisy), COAGULOPATHY (blood clot), DYSPNOEA (difficulty breathing), PULMONARY PAIN (pain in my right lung) and MYALGIA (body aches) had resolved. At the time of the report, CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100.4 degree (High) 100.4 degree F. On 04-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 05-May-2021, Blood test: abnormal (abnormal) D-dimer was elevated to 3600, Possible blood clot. On 05-May-2021, Computerised tomogram: abnormal (abnormal) Developed Pleurisy.         Symptoms: Patient reported that he had spiked fever and Difficulty breathing after vaccination.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-103195, MOD-2021-103270 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-JUN-2021 contains Significant information: Added Patient Demographics, Medical History, Lab Data, Suspect Drug Information, Concomitant medications, Treatment Medication, New Events added, Event outcome added.