chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: Not able to get 2nd dose on the due date; Not feeling well; Low grade intermittent fever; This spontaneous case was reported by a consumer concerning himself of a 70-year-old male patient who received Moderna COVID-19 Vaccine (mRNA-1273) and experienced Inappropriate schedule of product administration (Not able to get 2nd dose on the due date), Malaise (Not feeling well) and Pyrexia (Low grade intermittent fever).     The patient's medical history and concomitant medications were not reported.  On 26-Feb-2021, the patient received first dose of mRNA-1273 of batch no. 025A21A via Intramuscular 1 dosage form. On 26-Mar-2021, the patient experienced malaise (Not feeling well) and pyrexia (Low grade intermittent fever). On 27-Mar-2021, the patient experienced inappropriate schedule of product administration (Not able to get 2nd dose on the due date).    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: Results pending.  Treatment medication included ibuprofen.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   At the time of the report, inappropriate schedule of product administration (Not able to get 2nd dose on the due date), malaise (Not feeling well) and pyrexia (Low grade intermittent fever) outcome was unknown.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Productive cough, Rhinorrhoea
Clinical narrative: Phlegm in her throat; Nose was runny; Like a cold; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Phlegm in her throat), RHINORRHOEA (Nose was runny) and NASOPHARYNGITIS (Like a cold) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 PRODUCTIVE COUGH (Phlegm in her throat), RHINORRHOEA (Nose was runny) and NASOPHARYNGITIS (Like a cold). The patient was treated with AZITHROMYCIN at an unspecified dose and frequency. At the time of the report, PRODUCTIVE COUGH (Phlegm in her throat), RHINORRHOEA (Nose was runny) and NASOPHARYNGITIS (Like a cold) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Patient reported that all adverse events that were previously reported had resolved and she was "doing good".    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: TCR was added. Provided event outcome.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Rash, Swelling
Clinical narrative: Necking swelling; Neck tightness; Rash on Neck; Rash on Chest; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Necking swelling), MUSCLE TIGHTNESS (Neck tightness), RASH (Rash on Neck) and RASH (Rash on Chest) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced SWELLING (Necking swelling), MUSCLE TIGHTNESS (Neck tightness), RASH (Rash on Neck) and RASH (Rash on Chest). At the time of the report, SWELLING (Necking swelling), MUSCLE TIGHTNESS (Neck tightness), RASH (Rash on Neck) and RASH (Rash on Chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Invalid dose : Vaccine administered to a patient younger than 18 years old; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021. The most recent information was received on 06-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Invalid dose : Vaccine administered to a patient younger than 18 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals and Asthma (as per her mother).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Invalid dose : Vaccine administered to a patient younger than 18 years old). On 23-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Invalid dose : Vaccine administered to a patient younger than 18 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Upon an internal review on 20 May 2021, the age was corrected to 16 years in the narrative. Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up Received on 06-apr-2021 Contains Added: Date of birth, Weight and height, Race, historical condition and allergy.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot # unknown, with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 017B21A) for COVID-19 vaccination.   No Medical History information was reported.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 27-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-MAY 2021 contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: patient received 0.25ml dose; A spontaneous report was received from a healthcare professional , concerning a female patient of 69 years of age, a prisoner , who received  Moderna's COVID-19 vaccine and she received only 0.25 ml of the dose.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 25-mar-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number  017B21A) via  intramuscular route on her left arm for COVID-19 infection prophylaxis.  On 25-mar-2021,the patient was administered 0.25m l doses of Moderna vaccine for prophylaxis under dose. Prison Nurses would like to know how to move forward and if another dose should be administered immediately.  Action taken with mRNA-1273 in response to the event was unknown  The outcome of the event, the patient received 0.25 ml dose was recovered and resolved.; Reporter's Comments: This report refers to a case of accidental under dose for mRNA-1273, lot # 027A21A with no associated AEs.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site warmth
Clinical narrative: Redness at injection; Heat At Injection Site; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE WARMTH (Heat At Injection Site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE WARMTH (Heat At Injection Site). At the time of the report, INJECTION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE WARMTH (Heat At Injection Site) 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Vaccination site pain
Clinical narrative: Loss of taste; soreness in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 27-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) and VACCINATION SITE PAIN (soreness in arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced AGEUSIA (Loss of taste) and VACCINATION SITE PAIN (soreness in arm). At the time of the report, AGEUSIA (Loss of taste) and VACCINATION SITE PAIN (soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding
Clinical narrative: Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of BREAST FEEDING (Breast feeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No medical history was provided by reporter.  No concomitant medication reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced BREAST FEEDING (Breast feeding). At the time of the report, BREAST FEEDING (Breast feeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Binocular eye movement disorder, Chills, Fatigue, Headache, Insomnia
Clinical narrative: Sleeping often; Convergence insufficiency; Difficulty seeing; Soreness; Body ache; Intense pain in her arm; severe headache; Exhausted; chills; Severe migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Severe migraine), INSOMNIA (Sleeping often), BINOCULAR EYE MOVEMENT DISORDER (Convergence insufficiency), VISUAL IMPAIRMENT (Difficulty seeing) and PAIN (Soreness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract extraction in 2011. Concurrent medical conditions included Hypothyroidism since 1944, Hypertension since 1980, Penicillin allergy, Allergy to antibiotic (Vancomycin), Food allergy (Crab) and Food allergy (Shrimp).   On 21-Feb-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021 at 7:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced MIGRAINE (Severe migraine), PAIN (Soreness), PAIN (Body ache), PAIN IN EXTREMITY (Intense pain in her arm), HEADACHE (severe headache), FATIGUE (Exhausted) and CHILLS (chills). On an unknown date, the patient experienced INSOMNIA (Sleeping often), BINOCULAR EYE MOVEMENT DISORDER (Convergence insufficiency) and VISUAL IMPAIRMENT (Difficulty seeing). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-May-2021, MIGRAINE (Severe migraine) had resolved with sequelae. At the time of the report, INSOMNIA (Sleeping often), BINOCULAR EYE MOVEMENT DISORDER (Convergence insufficiency), VISUAL IMPAIRMENT (Difficulty seeing), PAIN (Soreness), PAIN (Body ache), PAIN IN EXTREMITY (Intense pain in her arm), HEADACHE (severe headache), FATIGUE (Exhausted) and CHILLS (chills) outcome was unknown.            Other treatment medication included a nasal spray. Concomitant drug used by the patient is CULTRELLE as a probiotic.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received and it contains updated medical history, allergies, product details, concomitant medications, treatment medications and events.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Pain in extremity, Visual impairment
Clinical narrative: Sleeping often; Convergence insufficiency; Difficulty seeing; Soreness; Body ache; Intense pain in her arm; severe headache; Exhausted; chills; Severe migraine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (Severe migraine), INSOMNIA (Sleeping often), BINOCULAR EYE MOVEMENT DISORDER (Convergence insufficiency), VISUAL IMPAIRMENT (Difficulty seeing) and PAIN (Soreness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract extraction in 2011. Concurrent medical conditions included Hypothyroidism since 1944, Hypertension since 1980, Penicillin allergy, Allergy to antibiotic (Vancomycin), Food allergy (Crab) and Food allergy (Shrimp).   On 21-Feb-2021 at 12:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021 at 7:10 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced MIGRAINE (Severe migraine), PAIN (Soreness), PAIN (Body ache), PAIN IN EXTREMITY (Intense pain in her arm), HEADACHE (severe headache), FATIGUE (Exhausted) and CHILLS (chills). On an unknown date, the patient experienced INSOMNIA (Sleeping often), BINOCULAR EYE MOVEMENT DISORDER (Convergence insufficiency) and VISUAL IMPAIRMENT (Difficulty seeing). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-May-2021, MIGRAINE (Severe migraine) had resolved with sequelae. At the time of the report, INSOMNIA (Sleeping often), BINOCULAR EYE MOVEMENT DISORDER (Convergence insufficiency), VISUAL IMPAIRMENT (Difficulty seeing), PAIN (Soreness), PAIN (Body ache), PAIN IN EXTREMITY (Intense pain in her arm), HEADACHE (severe headache), FATIGUE (Exhausted) and CHILLS (chills) outcome was unknown.            Other treatment medication included a nasal spray. Concomitant drug used by the patient is CULTRELLE as a probiotic.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow up received and it contains updated medical history, allergies, product details, concomitant medications, treatment medications and events.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: arm soreness; fever; headache; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis and Hypercholesterolemia. Concomitant products included ROSUVASTATIN for Hypercholesterolemia, CALCIUM CITRATE and DENOSUMAB (PROLIA) for Osteoporosis.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Feb-2021, PAIN IN EXTREMITY (arm soreness), PYREXIA (fever), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-059629 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up received on 12-May-2021 and updated reporter contact information. On 12-Jul-2021: Follow up received on 12-Jul-2021 and contains no new information
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) and DOCUSATE SODIUM (STOOL SOFTENER) for an unknown indication.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Apr-2021. On 18-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 18-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Migraine, Vomiting
Clinical narrative: extremely sick; severe migraine, couldn't open her eyes; threw up 6 times; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely sick), MIGRAINE (severe migraine, couldn't open her eyes) and VOMITING (threw up 6 times) 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 24-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 ILLNESS (extremely sick), MIGRAINE (severe migraine, couldn't open her eyes) and VOMITING (threw up 6 times). At the time of the report, ILLNESS (extremely sick), MIGRAINE (severe migraine, couldn't open her eyes) and VOMITING (threw up 6 times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received 0.25ml of dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose). On 25-Mar-2021, INCORRECT DOSE ADMINISTERED (patient received 0.25ml of dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant medication provided.  Nurses administered 0.25ml doses to 5 patients all patients were employees of the prison.  This report refers to a case of incorrect dose administered for mRNA-1273, lot # 017B21Awith no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # 017B21Awith no associated AEs.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypokinesia, Inappropriate schedule of product administration, Influenza like illness, Malaise
Clinical narrative: Been laid up since/ saying how terribly he feels/ is sorta in limbo; Not moving at all; Can't even get up; Having flu like symptoms; Feels malaise; He sleeps 12 hours; Pain; Muscle aches; Got the second dose early before 22 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Been laid up since/ saying how terribly he feels/ is sorta in limbo), HYPOKINESIA (Not moving at all), MOVEMENT DISORDER (Can't even get up), INFLUENZA LIKE ILLNESS (Having flu like symptoms) and MALAISE (Feels malaise) in a 67-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 in January 2020. Concomitant products included METOPROLOL for an unknown indication.   On 19-Mar-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 19-Mar-2021, the patient experienced FEELING ABNORMAL (Been laid up since/ saying how terribly he feels/ is sorta in limbo), HYPOKINESIA (Not moving at all), MOVEMENT DISORDER (Can't even get up), INFLUENZA LIKE ILLNESS (Having flu like symptoms), MALAISE (Feels malaise), SOMNOLENCE (He sleeps 12 hours), PAIN (Pain), MYALGIA (Muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose early before 22 days). On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose early before 22 days) had resolved. At the time of the report, FEELING ABNORMAL (Been laid up since/ saying how terribly he feels/ is sorta in limbo), HYPOKINESIA (Not moving at all), MOVEMENT DISORDER (Can't even get up), INFLUENZA LIKE ILLNESS (Having flu like symptoms), MALAISE (Feels malaise), SOMNOLENCE (He sleeps 12 hours), PAIN (Pain) and MYALGIA (Muscle aches) outcome was unknown.            Treatment medications not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received and reported event terms updated.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Myalgia, Pain, Somnolence
Clinical narrative: Been laid up since/ saying how terribly he feels/ is sorta in limbo; Not moving at all; Can't even get up; Having flu like symptoms; Feels malaise; He sleeps 12 hours; Pain; Muscle aches; Got the second dose early before 22 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Been laid up since/ saying how terribly he feels/ is sorta in limbo), HYPOKINESIA (Not moving at all), MOVEMENT DISORDER (Can't even get up), INFLUENZA LIKE ILLNESS (Having flu like symptoms) and MALAISE (Feels malaise) in a 67-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 in January 2020. Concomitant products included METOPROLOL for an unknown indication.   On 19-Mar-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 19-Mar-2021, the patient experienced FEELING ABNORMAL (Been laid up since/ saying how terribly he feels/ is sorta in limbo), HYPOKINESIA (Not moving at all), MOVEMENT DISORDER (Can't even get up), INFLUENZA LIKE ILLNESS (Having flu like symptoms), MALAISE (Feels malaise), SOMNOLENCE (He sleeps 12 hours), PAIN (Pain), MYALGIA (Muscle aches) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose early before 22 days). On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the second dose early before 22 days) had resolved. At the time of the report, FEELING ABNORMAL (Been laid up since/ saying how terribly he feels/ is sorta in limbo), HYPOKINESIA (Not moving at all), MOVEMENT DISORDER (Can't even get up), INFLUENZA LIKE ILLNESS (Having flu like symptoms), MALAISE (Feels malaise), SOMNOLENCE (He sleeps 12 hours), PAIN (Pain) and MYALGIA (Muscle aches) outcome was unknown.            Treatment medications not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received and reported event terms updated.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Diarrhoea, Dysarthria, Magnetic resonance imaging, Vaccination site paraesthesia
Clinical narrative: Diarrhoea; Slurred speech; Paresthesia (electricusion) on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), DYSARTHRIA (Slurred speech) and VACCINATION SITE PARAESTHESIA (Paresthesia (electricusion) on the left arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), DYSARTHRIA (Slurred speech) and VACCINATION SITE PARAESTHESIA (Paresthesia (electricusion) on the left arm). The patient was treated with METFORMIN at an unspecified dose and frequency. On 23-Mar-2021, VACCINATION SITE PARAESTHESIA (Paresthesia (electricusion) on the left arm) had resolved. At the time of the report, DIARRHOEA (Diarrhoea) and DYSARTHRIA (Slurred speech) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Computerised tomogram: negative (Negative) Negative. On 23-Mar-2021, Magnetic resonance imaging: negative (Negative) MRI of the carotid and brain to exclude stroke and blood work to exclude myocardial infarction were done.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation
Clinical narrative: Imperceptible inflammation injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (Imperceptible inflammation injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE INFLAMMATION (Imperceptible inflammation injection site). At the time of the report, INJECTION SITE INFLAMMATION (Imperceptible inflammation injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Concomitant medications were not provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 received dose; A spontaneous report was received from an HCP, concerning a 16-year-old male patient, who received Moderna's COVID-19 vaccine and patient under 18 years received the dose (Product administered to patient of inappropriate age).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Feb 2021, the patient received his first of the two planned vaccine doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis.   On 26 Feb 2021, the patient arrived at the health care providers clinic to receive second dose.   The HCP wants to know if the patient should receive second dose of the vaccine.  No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, product administration to the patient of inappropriate age, was considered to be resolved at the time of this report.; Reporter's Comments: This report refers to a case of, Product administered to patient of inappropriate age, for mRNA-1273, lot # Unknown,  with no associated AEs.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall, Fatigue, Headache, Vaccination site discolouration
Clinical narrative: Fell right over upon getting up in bed; Dizziness; Headache; Tiredness; Injection site appears black and blue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Injection site appears black and blue), FALL (Fell right over upon getting up in bed), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Tiredness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis and Dyslipidemia. Concomitant products included ROSUVASTATIN for Dyslipidemia, CALCIUM CITRATE for Osteoporosis.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Injection site appears black and blue), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Tiredness). On 27-Mar-2021, the patient experienced FALL (Fell right over upon getting up in bed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (Injection site appears black and blue), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Tiredness) was resolving and FALL (Fell right over upon getting up in bed) outcome was unknown.            Treatment details included Tylenol.   This case was linked to MOD-2021-059621 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up was added on 12 May 2021 and AE contact information was updated.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose not given in recommended time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time) 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 29-Jan-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 PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not given in recommended time) 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.   No relevant concomitant medications were reported. No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Painful upper arm; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful upper arm) and INJECTION SITE PAIN (Injection site soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Painful upper arm) and INJECTION SITE PAIN (Injection site soreness). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 13-Mar-2021, INJECTION SITE PAIN (Injection site soreness) had resolved. On 14-Mar-2021, PAIN IN EXTREMITY (Painful upper arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Chills, Feeling abnormal, Headache
Clinical narrative: injection site is sore/numb; just feels really bad; throat is sore from vomiting; bones hurt in her hands and arms; her bones hurt in arms; feels weak; bad Chills; low grade fever; Headache; vomiting; feeling nauseous; injection site is sore/numb; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (injection site is sore/numb), FEELING ABNORMAL (just feels really bad), OROPHARYNGEAL PAIN (throat is sore from vomiting), PAIN IN EXTREMITY (bones hurt in her hands and arms) and BONE PAIN (her bones hurt in arms) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE ANAESTHESIA (injection site is sore/numb), FEELING ABNORMAL (just feels really bad), OROPHARYNGEAL PAIN (throat is sore from vomiting), PAIN IN EXTREMITY (bones hurt in her hands and arms), BONE PAIN (her bones hurt in arms), ASTHENIA (feels weak), CHILLS (bad Chills), PYREXIA (low grade fever), HEADACHE (Headache), VOMITING (vomiting), NAUSEA (feeling nauseous) and VACCINATION SITE PAIN (injection site is sore/numb). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 ml. At the time of the report, VACCINATION SITE ANAESTHESIA (injection site is sore/numb), FEELING ABNORMAL (just feels really bad), OROPHARYNGEAL PAIN (throat is sore from vomiting), PAIN IN EXTREMITY (bones hurt in her hands and arms), BONE PAIN (her bones hurt in arms), ASTHENIA (feels weak), CHILLS (bad Chills), PYREXIA (low grade fever), HEADACHE (Headache), VOMITING (vomiting), NAUSEA (feeling nauseous) and VACCINATION SITE PAIN (injection site is sore/numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non significant follow up received on 11-MAY-2021, no new information
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia, Vaccination site anaesthesia
Clinical narrative: injection site is sore/numb; just feels really bad; throat is sore from vomiting; bones hurt in her hands and arms; her bones hurt in arms; feels weak; bad Chills; low grade fever; Headache; vomiting; feeling nauseous; injection site is sore/numb; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (injection site is sore/numb), FEELING ABNORMAL (just feels really bad), OROPHARYNGEAL PAIN (throat is sore from vomiting), PAIN IN EXTREMITY (bones hurt in her hands and arms) and BONE PAIN (her bones hurt in arms) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE ANAESTHESIA (injection site is sore/numb), FEELING ABNORMAL (just feels really bad), OROPHARYNGEAL PAIN (throat is sore from vomiting), PAIN IN EXTREMITY (bones hurt in her hands and arms), BONE PAIN (her bones hurt in arms), ASTHENIA (feels weak), CHILLS (bad Chills), PYREXIA (low grade fever), HEADACHE (Headache), VOMITING (vomiting), NAUSEA (feeling nauseous) and VACCINATION SITE PAIN (injection site is sore/numb). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 ml. At the time of the report, VACCINATION SITE ANAESTHESIA (injection site is sore/numb), FEELING ABNORMAL (just feels really bad), OROPHARYNGEAL PAIN (throat is sore from vomiting), PAIN IN EXTREMITY (bones hurt in her hands and arms), BONE PAIN (her bones hurt in arms), ASTHENIA (feels weak), CHILLS (bad Chills), PYREXIA (low grade fever), HEADACHE (Headache), VOMITING (vomiting), NAUSEA (feeling nauseous) and VACCINATION SITE PAIN (injection site is sore/numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non significant follow up received on 11-MAY-2021, no new information
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: injection site is sore/numb; just feels really bad; throat is sore from vomiting; bones hurt in her hands and arms; her bones hurt in arms; feels weak; bad Chills; low grade fever; Headache; vomiting; feeling nauseous; injection site is sore/numb; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (injection site is sore/numb), FEELING ABNORMAL (just feels really bad), OROPHARYNGEAL PAIN (throat is sore from vomiting), PAIN IN EXTREMITY (bones hurt in her hands and arms) and BONE PAIN (her bones hurt in arms) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE ANAESTHESIA (injection site is sore/numb), FEELING ABNORMAL (just feels really bad), OROPHARYNGEAL PAIN (throat is sore from vomiting), PAIN IN EXTREMITY (bones hurt in her hands and arms), BONE PAIN (her bones hurt in arms), ASTHENIA (feels weak), CHILLS (bad Chills), PYREXIA (low grade fever), HEADACHE (Headache), VOMITING (vomiting), NAUSEA (feeling nauseous) and VACCINATION SITE PAIN (injection site is sore/numb). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 ml. At the time of the report, VACCINATION SITE ANAESTHESIA (injection site is sore/numb), FEELING ABNORMAL (just feels really bad), OROPHARYNGEAL PAIN (throat is sore from vomiting), PAIN IN EXTREMITY (bones hurt in her hands and arms), BONE PAIN (her bones hurt in arms), ASTHENIA (feels weak), CHILLS (bad Chills), PYREXIA (low grade fever), HEADACHE (Headache), VOMITING (vomiting), NAUSEA (feeling nauseous) and VACCINATION SITE PAIN (injection site is sore/numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Non significant follow up received on 11-MAY-2021, no new information
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Rash, Vaccination site pain
Clinical narrative: Rash on both sides of her neck and ears; Chills; Tenderness in arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on both sides of her neck and ears), CHILLS (Chills) and VACCINATION SITE PAIN (Tenderness in arm of injection) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CHILLS (Chills) and VACCINATION SITE PAIN (Tenderness in arm of injection). On 26-Mar-2021, the patient experienced RASH (Rash on both sides of her neck and ears). At the time of the report, RASH (Rash on both sides of her neck and ears), CHILLS (Chills) and VACCINATION SITE PAIN (Tenderness in arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Night sweats, Pain, Pain in extremity
Clinical narrative: Sore arm; Felt sleepy; Achy; Midnight being sweaty; Low grade headache; Kind of ran down, stayed in bed most of the day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Felt sleepy), PAIN (Achy), NIGHT SWEATS (Midnight being sweaty) and HEADACHE (Low grade headache) in a 53-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.     Concurrent medical conditions included Asthma (Medical history reported as mild asthma) and Seasonal allergy (Medical history reported as seasonal allergy). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 16-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 PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Felt sleepy), PAIN (Achy), NIGHT SWEATS (Midnight being sweaty), HEADACHE (Low grade headache) and FATIGUE (Kind of ran down, stayed in bed most of the day). At the time of the report, PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Felt sleepy), PAIN (Achy), NIGHT SWEATS (Midnight being sweaty), HEADACHE (Low grade headache) and FATIGUE (Kind of ran down, stayed in bed most of the day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Sore arm; Felt sleepy; Achy; Midnight being sweaty; Low grade headache; Kind of ran down, stayed in bed most of the day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Felt sleepy), PAIN (Achy), NIGHT SWEATS (Midnight being sweaty) and HEADACHE (Low grade headache) in a 53-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.     Concurrent medical conditions included Asthma (Medical history reported as mild asthma) and Seasonal allergy (Medical history reported as seasonal allergy). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 16-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 PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Felt sleepy), PAIN (Achy), NIGHT SWEATS (Midnight being sweaty), HEADACHE (Low grade headache) and FATIGUE (Kind of ran down, stayed in bed most of the day). At the time of the report, PAIN IN EXTREMITY (Sore arm), SOMNOLENCE (Felt sleepy), PAIN (Achy), NIGHT SWEATS (Midnight being sweaty), HEADACHE (Low grade headache) and FATIGUE (Kind of ran down, stayed in bed most of the day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 94.0
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis, Rhinorrhoea
Clinical narrative: Psoriasis scalp; Nasal drip; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis scalp) and RHINORRHOEA (Nasal drip) in a 94-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PSORIASIS (Psoriasis scalp) and RHINORRHOEA (Nasal drip). At the time of the report, PSORIASIS (Psoriasis scalp) and RHINORRHOEA (Nasal drip) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Shampoo for an unknown indication.  Patient self-administered unknown shampoo for an unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Report follow-up received and contains no new information.