chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia, Vaccination site pain
Clinical narrative: Vaccine not indicated; Sore arm; Pain at injection site; Headache; Body ache; Chills; Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine not indicated), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache) and MYALGIA (Body ache) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 09-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine not indicated), VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever). 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with EPINEPHRINE (EPIPEN) at a dose of 1 dosage form. On 09-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine not indicated) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102-103 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient will not be given second dose.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Added lab data. Added concomitant and treatment medications. Added second dose details of a patient. Added new events fever, sore arm. Updated reporter details. Updated patient details. Updated the time of first dose. Updated action taken. Updated event outcome. On 07-May-2021: Follow up information received on 07-MAY-2021 contains no new information.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year  old male) for mRNA-1273 (lot number 030M20A) with associated AEs reported as pain at injection site, headache, body pain, and chills.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Couldn't open her hands/ trouble maneuvering her wheelchair; Hands are very painful; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Couldn't open her hands/ trouble maneuvering her wheelchair) and PAIN IN EXTREMITY (Hands are very painful) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high, High cholesterol, Food allergy and Amputee.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Couldn't open her hands/ trouble maneuvering her wheelchair) and PAIN IN EXTREMITY (Hands are very painful). At the time of the report, JOINT RANGE OF MOTION DECREASED (Couldn't open her hands/ trouble maneuvering her wheelchair) and PAIN IN EXTREMITY (Hands are very painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: 2 red patches in  arm; injection site pruritus; injection site swelling; injection site red blotch; injection site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warmth), RASH (2 red patches in  arm), INJECTION SITE PRURITUS (injection site pruritus), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site red blotch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site warmth), INJECTION SITE PRURITUS (injection site pruritus), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site red blotch). On 28-Feb-2021, the patient experienced RASH (2 red patches in  arm). At the time of the report, VACCINATION SITE WARMTH (injection site warmth), RASH (2 red patches in  arm), INJECTION SITE PRURITUS (injection site pruritus), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site red blotch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Dehydration
Clinical narrative: Got sick; All he wants to do is sleep; He has no appetite; He cannot get enough to drink; He cannot get warm; He does not feel like he can get up; Running a temperature of 101.8 F; He has chills real bad; He is just tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), SOMNOLENCE (All he wants to do is sleep), DECREASED APPETITE (He has no appetite), DEHYDRATION (He cannot get enough to drink) and FEELING COLD (He cannot get warm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ILLNESS (Got sick). 13-Feb-2021, the patient experienced SOMNOLENCE (All he wants to do is sleep), DECREASED APPETITE (He has no appetite), DEHYDRATION (He cannot get enough to drink), FEELING COLD (He cannot get warm), ASTHENIA (He does not feel like he can get up), PYREXIA (Running a temperature of 101.8 F), CHILLS (He has chills real bad) and FATIGUE (He is just tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of Unknown. On 15-Feb-2021, PYREXIA (Running a temperature of 101.8 F) had resolved. On 16-Feb-2021, ILLNESS (Got sick), SOMNOLENCE (All he wants to do is sleep), DEHYDRATION (He cannot get enough to drink), FEELING COLD (He cannot get warm), ASTHENIA (He does not feel like he can get up) and CHILLS (He has chills real bad) had resolved. At the time of the report, DECREASED APPETITE (He has no appetite) and FATIGUE (He is just tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: 101.8 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: added second dose
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Illness, Pyrexia, Somnolence
Clinical narrative: Got sick; All he wants to do is sleep; He has no appetite; He cannot get enough to drink; He cannot get warm; He does not feel like he can get up; Running a temperature of 101.8 F; He has chills real bad; He is just tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick), SOMNOLENCE (All he wants to do is sleep), DECREASED APPETITE (He has no appetite), DEHYDRATION (He cannot get enough to drink) and FEELING COLD (He cannot get warm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ILLNESS (Got sick). 13-Feb-2021, the patient experienced SOMNOLENCE (All he wants to do is sleep), DECREASED APPETITE (He has no appetite), DEHYDRATION (He cannot get enough to drink), FEELING COLD (He cannot get warm), ASTHENIA (He does not feel like he can get up), PYREXIA (Running a temperature of 101.8 F), CHILLS (He has chills real bad) and FATIGUE (He is just tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of Unknown. On 15-Feb-2021, PYREXIA (Running a temperature of 101.8 F) had resolved. On 16-Feb-2021, ILLNESS (Got sick), SOMNOLENCE (All he wants to do is sleep), DEHYDRATION (He cannot get enough to drink), FEELING COLD (He cannot get warm), ASTHENIA (He does not feel like he can get up) and CHILLS (He has chills real bad) had resolved. At the time of the report, DECREASED APPETITE (He has no appetite) and FATIGUE (He is just tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Body temperature: 101.8 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: added second dose
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Chills, Feeling abnormal, Vaccination complication
Clinical narrative: not feeling too well; not feeling good; chills; bone in her body is hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling too well), FEELING ABNORMAL (not feeling good), CHILLS (chills) and BONE PAIN (bone in her body is hurting) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (not feeling too well), FEELING ABNORMAL (not feeling good), CHILLS (chills) and BONE PAIN (bone in her body is hurting). At the time of the report, VACCINATION COMPLICATION (not feeling too well), FEELING ABNORMAL (not feeling good), CHILLS (chills) and BONE PAIN (bone in her body is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Pain
Clinical narrative: Achy; tired; body aches; headache; chills; arm hurt around shoulder; This spontaneous case was reported by a consumer and describes the occurrence of body aches, PAIN, HEADACHE, CHILLS, and AXILLARY PAIN in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE, METOPROLOL, SOTALOL, ENTRESTO, CLONAZEPAM, PRAVASTATIN, VITAMIN D, ALLOPURINOL, FLOMAX, and FARXIGA for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (body aches), HEADACHE, CHILLS, and AXILLARY PAIN. On 14-Feb-2021, the patient experienced PAIN and FATIGUE. The patient was treated with TYLENOL at a dose of 1 dosage form. At the time of the report, body aches, PAIN, HEADACHE, CHILLS, AXILLARY PAIN, and FATIGUE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Peripheral swelling
Clinical narrative: Arm swollen; Arm hard; Arm redness; A spontaneous report was received from a consumer concerning his wife , female patient (age not provided) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm swollen/peripheral swelling, arm hard/induration and arm redness/erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: N/A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced swollen arm, arm hard and arm redness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events arm swollen, arm hard and  arm redness were unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Muscle spasms, Peripheral swelling
Clinical narrative: muscle spasms on left side of body ; arm, leg, and shin; swollen arm; chills, shivers; headache; redness on swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasms on left side of body ; arm, leg, and shin), PERIPHERAL SWELLING (swollen arm), CHILLS (chills, shivers), HEADACHE (headache) and ERYTHEMA (redness on swollen arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced MUSCLE SPASMS (muscle spasms on left side of body ; arm, leg, and shin), PERIPHERAL SWELLING (swollen arm), CHILLS (chills, shivers), HEADACHE (headache) and ERYTHEMA (redness on swollen arm). At the time of the report, MUSCLE SPASMS (muscle spasms on left side of body ; arm, leg, and shin), PERIPHERAL SWELLING (swollen arm), CHILLS (chills, shivers), HEADACHE (headache) and ERYTHEMA (redness on swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Rash; High fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PYREXIA (High fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced RASH (Rash) and PYREXIA (High fever). At the time of the report, RASH (Rash) and PYREXIA (High fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pruritus
Clinical narrative: Bee sting sensations at random places on her body; Itching at random places on her body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (Bee sting sensations at random places on her body) and PRURITUS (Itching at random places on her body) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 10-Feb-2021, the patient experienced PAIN OF SKIN (Bee sting sensations at random places on her body) and PRURITUS (Itching at random places on her body).   At the time of the report, PAIN OF SKIN (Bee sting sensations at random places on her body) and PRURITUS (Itching at random places on her body) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: full blown COVID side effects; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (full blown COVID side effects) 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 SUSPECTED COVID-19 (full blown COVID side effects). At the time of the report, SUSPECTED COVID-19 (full blown COVID side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is super hot) and VACCINATION SITE SWELLING (Injection site is swollen). On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site is red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site is super hot), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is swollen) outcome was unknown and PYREXIA (Fever) and MYALGIA (Body aches) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: extreme itching; Red patch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (extreme itching) and RASH (Red patch) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mastectomy.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced PRURITUS (extreme itching) and RASH (Red patch). At the time of the report, PRURITUS (extreme itching) and RASH (Red patch) 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.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with covid) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013C20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced COVID-19 (Diagnosed with covid). At the time of the report, COVID-19 (Diagnosed with covid) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Aspartate aminotransferase decreased, Blood chloride, Lymphocyte count, Lymphopenia
Clinical narrative: lowcount of Lymphocytes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOPENIA (lowcount of Lymphocytes) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 0AJ20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Hypertension.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced LYMPHOPENIA (lowcount of Lymphocytes). At the time of the report, LYMPHOPENIA (lowcount of Lymphocytes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Aspartate aminotransferase decreased: low Low. On 06-Feb-2021, Blood chloride: high High. On 06-Feb-2021, Lymphocyte count: low Low.         No relevant concomitant medications were reported. No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: Couldn't speak anymore, mumbled but couldn't say what I wanted to stay; This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M2CA) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced SPEECH DISORDER (Couldn't speak anymore, mumbled but couldn't say what I wanted to stay). On 10-Feb-2021, SPEECH DISORDER had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Headache, Nausea
Clinical narrative: back pain; Diarrhoea; stomach hurting; HEADACHE; NAUSEA; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (stomach hurting), HEADACHE (HEADACHE) and NAUSEA (NAUSEA) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Heart disorder.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced BACK PAIN (back pain), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (stomach hurting), HEADACHE (HEADACHE), NAUSEA (NAUSEA) and VOMITING (Vomiting). At the time of the report, BACK PAIN (back pain), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (stomach hurting), HEADACHE (HEADACHE), NAUSEA (NAUSEA) and VOMITING (Vomiting) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications include heart medication and blood pressure medication. No treatment medication details was reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: back pain; Diarrhoea; stomach hurting; HEADACHE; NAUSEA; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (stomach hurting), HEADACHE (HEADACHE) and NAUSEA (NAUSEA) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Heart disorder.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced BACK PAIN (back pain), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (stomach hurting), HEADACHE (HEADACHE), NAUSEA (NAUSEA) and VOMITING (Vomiting). At the time of the report, BACK PAIN (back pain), DIARRHOEA (Diarrhoea), ABDOMINAL PAIN UPPER (stomach hurting), HEADACHE (HEADACHE), NAUSEA (NAUSEA) and VOMITING (Vomiting) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medications include heart medication and blood pressure medication. No treatment medication details was reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Pain in extremity
Clinical narrative: Arm pain; Diarrhea; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), DIARRHOEA (Diarrhea), MYALGIA (Body aches) and CHILLS (Chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CHLORTHALIDONE, VITAMINS NOS, AMILORIDE, CABERGOLINE, PANTOPRAZOLE, POTASSIUM and ANASTROZOLE for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), DIARRHOEA (Diarrhea), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm pain), DIARRHOEA (Diarrhea), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also reported he receives injections for his kidneys. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Myalgia, Pyrexia, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: warm to the touch; itching; no fever but her temperature was a little bit elevated from her normal temperature; aches; injection site reaction - red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itching), PYREXIA (no fever but her temperature was a little bit elevated from her normal temperature), MYALGIA (aches) and INJECTION SITE ERYTHEMA (injection site reaction - red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ALLERGY) and FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE (GLUCOCORTICOID)) for Allergy, SIMVASTATIN for Cholesterol, HYDROCHLOROTHIAZIDE for Hypertension, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Vitamin D deficiency.    On 26-Jan-2021 at 7:36 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), PYREXIA (no fever but her temperature was a little bit elevated from her normal temperature), MYALGIA (aches), INJECTION SITE ERYTHEMA (injection site reaction - red) and VACCINATION SITE SWELLING (swollen). 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), INJECTION SITE ERYTHEMA (injection site reaction - red) and VACCINATION SITE SWELLING (swollen) had resolved and VACCINATION SITE PRURITUS (itching), PYREXIA (no fever but her temperature was a little bit elevated from her normal temperature) and MYALGIA (aches) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Additional information included patient details and event details. Added Dose 2 information, Concomitant medications and allergies.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: warm to the touch; itching; no fever but her temperature was a little bit elevated from her normal temperature; aches; injection site reaction - red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itching), PYREXIA (no fever but her temperature was a little bit elevated from her normal temperature), MYALGIA (aches) and INJECTION SITE ERYTHEMA (injection site reaction - red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ALLERGY) and FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE (GLUCOCORTICOID)) for Allergy, SIMVASTATIN for Cholesterol, HYDROCHLOROTHIAZIDE for Hypertension, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for Vitamin D deficiency.    On 26-Jan-2021 at 7:36 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), PYREXIA (no fever but her temperature was a little bit elevated from her normal temperature), MYALGIA (aches), INJECTION SITE ERYTHEMA (injection site reaction - red) and VACCINATION SITE SWELLING (swollen). 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), INJECTION SITE ERYTHEMA (injection site reaction - red) and VACCINATION SITE SWELLING (swollen) had resolved and VACCINATION SITE PRURITUS (itching), PYREXIA (no fever but her temperature was a little bit elevated from her normal temperature) and MYALGIA (aches) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Additional information included patient details and event details. Added Dose 2 information, Concomitant medications and allergies.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: low grade fever; chest pain; Inappropriate age at vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), CHEST PAIN (chest pain) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 28-Feb-2021, the patient experienced PYREXIA (low grade fever) and CHEST PAIN (chest pain). On 27-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. At the time of the report, PYREXIA (low grade fever) and CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. Mother reports that the patient is disabled that's why she is qualified.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Tingling tongue; Numb lips; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling tongue) and HYPOAESTHESIA ORAL (Numb lips) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA ORAL (Tingling tongue) and HYPOAESTHESIA ORAL (Numb lips). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 25-Feb-2021, PARAESTHESIA ORAL (Tingling tongue) and HYPOAESTHESIA ORAL (Numb lips) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Significantly redder and as big as can of coke; Really itchy; Slight pale rash; Skin would feel itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Skin would feel itchy at injection site), VACCINATION SITE PRURITUS (Really itchy), VACCINATION SITE RASH (Slight pale rash) and VACCINATION SITE ERYTHEMA (Significantly redder and as big as can of coke) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Sensitive skin (The patient stated that she get rashes and itchiness very easily.). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), LOSARTAN, ESTROGENS CONJUGATED (PREMARIN) and PREDNISONE ( same dose since 5-6 years) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Skin would feel itchy at injection site) and VACCINATION SITE RASH (Slight pale rash). On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Really itchy). On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Significantly redder and as big as can of coke). At the time of the report, VACCINATION SITE PRURITUS (Skin would feel itchy at injection site), VACCINATION SITE PRURITUS (Really itchy), VACCINATION SITE RASH (Slight pale rash) and VACCINATION SITE ERYTHEMA (Significantly redder and as big as can of coke) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included body lotion. Patient reports "I'm putting lotion on it and its still the same"
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: very sore arm for two days; arm is now very itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (very sore arm for two days) and VACCINATION SITE PRURITUS (arm is now very itchy) 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 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (very sore arm for two days) and VACCINATION SITE PRURITUS (arm is now very itchy). At the time of the report, VACCINATION SITE PAIN (very sore arm for two days) had resolved and VACCINATION SITE PRURITUS (arm is now very itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain
Clinical narrative: really achy; whole neck hurts; pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (really achy), NECK PAIN (whole neck hurts) and PAIN (pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (pain). On 28-Feb-2021, the patient experienced PAIN (really achy) and NECK PAIN (whole neck hurts). At the time of the report, PAIN (really achy), NECK PAIN (whole neck hurts) and PAIN (pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: Aching in knees; joints aching; pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Aching in knees), ARTHRALGIA (joints aching), PAIN (pain) and FATIGUE (fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 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. In February 2021, the patient experienced ARTHRALGIA (Aching in knees), ARTHRALGIA (joints aching), PAIN (pain) and FATIGUE (fatigue). At the time of the report, ARTHRALGIA (Aching in knees), ARTHRALGIA (joints aching), PAIN (pain) and FATIGUE (fatigue) outcome was unknown.            Concomitant medications were not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site erythema, Vaccination site pain, Vaccination site reaction
Clinical narrative: COVID arm; injection site is very hot; Terrible pain in her right foot and the pain started to radiate upward; Small amount of soreness at the injection site; Red for a 5-6 inch area; Very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site is very hot), PAIN (Terrible pain in her right foot and the pain started to radiate upward), VACCINATION SITE PAIN (Small amount of soreness at the injection site) and VACCINATION SITE ERYTHEMA (Red for a 5-6 inch area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site is very hot), PAIN (Terrible pain in her right foot and the pain started to radiate upward), VACCINATION SITE PAIN (Small amount of soreness at the injection site), VACCINATION SITE ERYTHEMA (Red for a 5-6 inch area) and FATIGUE (Very fatigued). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site is very hot), PAIN (Terrible pain in her right foot and the pain started to radiate upward), VACCINATION SITE PAIN (Small amount of soreness at the injection site), VACCINATION SITE ERYTHEMA (Red for a 5-6 inch area) and FATIGUE (Very fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: COVID arm; injection site is very hot; Terrible pain in her right foot and the pain started to radiate upward; Small amount of soreness at the injection site; Red for a 5-6 inch area; Very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site is very hot), PAIN (Terrible pain in her right foot and the pain started to radiate upward), VACCINATION SITE PAIN (Small amount of soreness at the injection site) and VACCINATION SITE ERYTHEMA (Red for a 5-6 inch area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site is very hot), PAIN (Terrible pain in her right foot and the pain started to radiate upward), VACCINATION SITE PAIN (Small amount of soreness at the injection site), VACCINATION SITE ERYTHEMA (Red for a 5-6 inch area) and FATIGUE (Very fatigued). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site is very hot), PAIN (Terrible pain in her right foot and the pain started to radiate upward), VACCINATION SITE PAIN (Small amount of soreness at the injection site), VACCINATION SITE ERYTHEMA (Red for a 5-6 inch area) and FATIGUE (Very fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Headache, Hypersomnia, Vaccination site pain
Clinical narrative: sore arm (injection site); headache; he just felt bad; poor appetite; sleeping a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm (injection site)), HEADACHE (headache), FEELING ABNORMAL (he just felt bad), DECREASED APPETITE (poor appetite) and HYPERSOMNIA (sleeping a lot) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm (injection site)), HEADACHE (headache), FEELING ABNORMAL (he just felt bad), DECREASED APPETITE (poor appetite) and HYPERSOMNIA (sleeping a lot). At the time of the report, VACCINATION SITE PAIN (sore arm (injection site)), HEADACHE (headache), FEELING ABNORMAL (he just felt bad), DECREASED APPETITE (poor appetite) and HYPERSOMNIA (sleeping a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site pain
Clinical narrative: Labored breathing; Burning at injection site that was on and off for two weeks; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Burning at injection site that was on and off for two weeks) and DYSPNOEA (Labored breathing) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INJECTION SITE PAIN (Burning at injection site that was on and off for two weeks). On 06-Feb-2021, the patient experienced DYSPNOEA (Labored breathing). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. On 07-Feb-2021, DYSPNOEA (Labored breathing) had resolved. At the time of the report, INJECTION SITE PAIN (Burning at injection site that was on and off for two weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment:Put ice and benedryl on injection site to help with symptoms. Conmed:blood pressure medicine and statin