chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Lymphadenopathy, Muscle twitching, Pain in extremity
Clinical narrative: She did not get her second dose.; Swollen lymph nodes on her left side; Pins and needles in her arms and legs; Intermittent twitching in her toes; She felt tired; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles in her arms and legs), MUSCLE TWITCHING (Intermittent twitching in her toes), PAIN IN EXTREMITY (Arm was sore), PRODUCT DOSE OMISSION ISSUE (She did not get her second dose.) and FATIGUE (She felt tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), ESTRADIOL (ESTRING) for Dryness vaginal, AZELAIC ACID (FINACEA) for Rosacea, ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 22-Feb-2021, the patient experienced FATIGUE (She felt tired). On 25-Feb-2021, the patient experienced PARAESTHESIA (Pins and needles in her arms and legs) and MUSCLE TWITCHING (Intermittent twitching in her toes). On 28-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on her left side). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She did not get her second dose.). On 22-Feb-2021, PAIN IN EXTREMITY (Arm was sore) and FATIGUE (She felt tired) had resolved. On 02-Mar-2021, LYMPHADENOPATHY (Swollen lymph nodes on her left side) had resolved. At the time of the report, PARAESTHESIA (Pins and needles in her arms and legs) and MUSCLE TWITCHING (Intermittent twitching in her toes) had not resolved and PRODUCT DOSE OMISSION ISSUE (She did not get her second dose.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Unspecified blood work came back normal.     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 treatment medications provided.     Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow-up received on 19-Jul-2021 contains significant information. The primary reporter contacts updated. The patient demographics updated. The patient's relevant history was updated. The concomitant products were added. The event outcome were updated as not recovered/not resolved for the events  "Pins and needles in her arms and legs" and "Intermittent twitching in her toes".
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Product dose omission issue
Clinical narrative: She did not get her second dose.; Swollen lymph nodes on her left side; Pins and needles in her arms and legs; Intermittent twitching in her toes; She felt tired; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles in her arms and legs), MUSCLE TWITCHING (Intermittent twitching in her toes), PAIN IN EXTREMITY (Arm was sore), PRODUCT DOSE OMISSION ISSUE (She did not get her second dose.) and FATIGUE (She felt tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), ESTRADIOL (ESTRING) for Dryness vaginal, AZELAIC ACID (FINACEA) for Rosacea, ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 22-Feb-2021, the patient experienced FATIGUE (She felt tired). On 25-Feb-2021, the patient experienced PARAESTHESIA (Pins and needles in her arms and legs) and MUSCLE TWITCHING (Intermittent twitching in her toes). On 28-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes on her left side). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She did not get her second dose.). On 22-Feb-2021, PAIN IN EXTREMITY (Arm was sore) and FATIGUE (She felt tired) had resolved. On 02-Mar-2021, LYMPHADENOPATHY (Swollen lymph nodes on her left side) had resolved. At the time of the report, PARAESTHESIA (Pins and needles in her arms and legs) and MUSCLE TWITCHING (Intermittent twitching in her toes) had not resolved and PRODUCT DOSE OMISSION ISSUE (She did not get her second dose.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Unspecified blood work came back normal.     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 treatment medications provided.     Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow-up received on 19-Jul-2021 contains significant information. The primary reporter contacts updated. The patient demographics updated. The patient's relevant history was updated. The concomitant products were added. The event outcome were updated as not recovered/not resolved for the events  "Pins and needles in her arms and legs" and "Intermittent twitching in her toes".
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) 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 ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment medication were not reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: a bright red rash on the backs of her legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (a bright red rash on the backs of her legs and arms) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced RASH ERYTHEMATOUS (a bright red rash on the backs of her legs and arms). At the time of the report, RASH ERYTHEMATOUS (a bright red rash on the backs of her legs and arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: fatigue; diarrhea; fever; body aches; headaches; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever) and PAIN (body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2012, the patient experienced CHILLS (chills). On 09-Apr-2021, the patient experienced FATIGUE (fatigue), DIARRHOEA (diarrhea), PYREXIA (fever), PAIN (body aches) and HEADACHE (headaches). At the time of the report, FATIGUE (fatigue), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), PAIN (body aches) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was reported as Anti Diarrhea   This case was linked to MOD-2021-073822, MOD-2021-073822 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue; diarrhea; fever; body aches; headaches; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever) and PAIN (body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2012, the patient experienced CHILLS (chills). On 09-Apr-2021, the patient experienced FATIGUE (fatigue), DIARRHOEA (diarrhea), PYREXIA (fever), PAIN (body aches) and HEADACHE (headaches). At the time of the report, FATIGUE (fatigue), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (fever), PAIN (body aches) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was reported as Anti Diarrhea   This case was linked to MOD-2021-073822, MOD-2021-073822 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Myalgia
Clinical narrative: Diagnosed with Covid-19; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19) and MYALGIA (sore left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MYALGIA (sore left arm). On 05-Apr-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). At the time of the report, COVID-19 (Diagnosed with Covid-19) and MYALGIA (sore left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on at the site of the injection from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on at the site of the injection from the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unkonwn) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on at the site of the injection from the vaccine). At the time of the report, VACCINATION SITE RASH (rash on at the site of the injection from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medications were provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Eye pain, Headache
Clinical narrative: pain moved down towards right eye; double vision right eye; bad headache over upper temporal on the right side; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain moved down towards right eye), DIPLOPIA (double vision right eye) and HEADACHE (bad headache over upper temporal on the right side) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (bad headache over upper temporal on the right side). On 01-Apr-2021, the patient experienced EYE PAIN (pain moved down towards right eye) and DIPLOPIA (double vision right eye). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, EYE PAIN (pain moved down towards right eye), DIPLOPIA (double vision right eye) and HEADACHE (bad headache over upper temporal on the right side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication for diabetic and blood pressure were unspecified.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Pyrexia
Clinical narrative: felt very weak; really bad headache; fever; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt very weak), HEADACHE (really bad headache), PYREXIA (fever) and NAUSEA (nauseated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     no medical history information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced ASTHENIA (felt very weak), HEADACHE (really bad headache), PYREXIA (fever) and NAUSEA (nauseated). The patient was treated with IBUPROFEN for Headache, Fever, Weakness and Nauseated, at an unspecified dose and frequency and ACETAMINOPHEN for Headache, Fever, Weakness generalised and Nauseated, at an unspecified dose and frequency. At the time of the report, ASTHENIA (felt very weak), HEADACHE (really bad headache), PYREXIA (fever) and NAUSEA (nauseated) outcome was unknown.            no concomitant product was reported. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Urinary tract infection
Clinical narrative: UTI; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FATIGUE (fatigue). On 09-Apr-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included Antibiotics.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash, Rash pruritic, Vaccination site pruritus
Clinical narrative: Itchy rash continued to spread to my entire abdomen; Hypersensitivity reaction; Itchy is the arm of the shot than it proceeded to all over; Rash in her stomach and other arm; Itch started the next day; a red rash appeared on my left arm surrounding the needle mark; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash continued to spread to my entire abdomen), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itchy is the arm of the shot than it proceeded to all over), RASH (Rash in her stomach and other arm) and VACCINATION SITE PRURITUS (Itch started the next day) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis since 2015 and Spinal stenosis since 2015. Concomitant products included FUROSEMIDE for Edema, LISINOPRIL for Hypertension, METOPROLOL for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE RASH (a red rash appeared on my left arm surrounding the needle mark). On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itch started the next day). On 07-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itchy is the arm of the shot than it proceeded to all over) and RASH (Rash in her stomach and other arm). On an unknown date, the patient experienced RASH PRURITIC (Itchy rash continued to spread to my entire abdomen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and HYDROCORTISONE (topical) for Itchy rash, at an unspecified dose and frequency. On 19-Apr-2021, HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itchy is the arm of the shot than it proceeded to all over), RASH (Rash in her stomach and other arm), VACCINATION SITE PRURITUS (Itch started the next day) and VACCINATION SITE RASH (a red rash appeared on my left arm surrounding the needle mark) had resolved. At the time of the report, RASH PRURITIC (Itchy rash continued to spread to my entire abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes: Antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May-2021, contains significant information.Added Patient demographics, medical history, Concomitant medications, new event was added, event outcome was added.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Itchy rash continued to spread to my entire abdomen; Hypersensitivity reaction; Itchy is the arm of the shot than it proceeded to all over; Rash in her stomach and other arm; Itch started the next day; a red rash appeared on my left arm surrounding the needle mark; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash continued to spread to my entire abdomen), HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itchy is the arm of the shot than it proceeded to all over), RASH (Rash in her stomach and other arm) and VACCINATION SITE PRURITUS (Itch started the next day) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis since 2015 and Spinal stenosis since 2015. Concomitant products included FUROSEMIDE for Edema, LISINOPRIL for Hypertension, METOPROLOL for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE RASH (a red rash appeared on my left arm surrounding the needle mark). On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itch started the next day). On 07-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itchy is the arm of the shot than it proceeded to all over) and RASH (Rash in her stomach and other arm). On an unknown date, the patient experienced RASH PRURITIC (Itchy rash continued to spread to my entire abdomen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and HYDROCORTISONE (topical) for Itchy rash, at an unspecified dose and frequency. On 19-Apr-2021, HYPERSENSITIVITY (Hypersensitivity reaction), PRURITUS (Itchy is the arm of the shot than it proceeded to all over), RASH (Rash in her stomach and other arm), VACCINATION SITE PRURITUS (Itch started the next day) and VACCINATION SITE RASH (a red rash appeared on my left arm surrounding the needle mark) had resolved. At the time of the report, RASH PRURITIC (Itchy rash continued to spread to my entire abdomen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes: Antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12-May-2021, contains significant information.Added Patient demographics, medical history, Concomitant medications, new event was added, event outcome was added.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to the touch) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to the touch). At the time of the report, VACCINATION SITE WARMTH (Injection site warm to the touch) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Feeling abnormal, Feeling cold, Musculoskeletal stiffness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Right after the shot, she felt stiffness in both arms and across the shoulders.), DYSGEUSIA (She also had metal taste in her mouth.), FEELING ABNORMAL (She also feels some sinus issues but it is very minor/ her system is warning her down), UPPER-AIRWAY COUGH SYNDROME (She has nasal drip but always has that. She just feels like her system is waring her down.) and FEELING COLD (She feels like she has a cold) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Right after the shot, she felt stiffness in both arms and across the shoulders.), DYSGEUSIA (She also had metal taste in her mouth.), FEELING ABNORMAL (She also feels some sinus issues but it is very minor/ her system is warning her down), UPPER-AIRWAY COUGH SYNDROME (She has nasal drip but always has that. She just feels like her system is waring her down.), FEELING COLD (She feels like she has a cold) and FATIGUE (She feels beat, feels run down, feels tired). At the time of the report, MUSCULOSKELETAL STIFFNESS (Right after the shot, she felt stiffness in both arms and across the shoulders.), DYSGEUSIA (She also had metal taste in her mouth.), FEELING ABNORMAL (She also feels some sinus issues but it is very minor/ her system is warning her down), UPPER-AIRWAY COUGH SYNDROME (She has nasal drip but always has that. She just feels like her system is waring her down.), FEELING COLD (She feels like she has a cold) and FATIGUE (She feels beat, feels run down, feels tired) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: TCR received contains non significant information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Right after the shot, she felt stiffness in both arms and across the shoulders.), DYSGEUSIA (She also had metal taste in her mouth.), FEELING ABNORMAL (She also feels some sinus issues but it is very minor/ her system is warning her down), UPPER-AIRWAY COUGH SYNDROME (She has nasal drip but always has that. She just feels like her system is waring her down.) and FEELING COLD (She feels like she has a cold) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Right after the shot, she felt stiffness in both arms and across the shoulders.), DYSGEUSIA (She also had metal taste in her mouth.), FEELING ABNORMAL (She also feels some sinus issues but it is very minor/ her system is warning her down), UPPER-AIRWAY COUGH SYNDROME (She has nasal drip but always has that. She just feels like her system is waring her down.), FEELING COLD (She feels like she has a cold) and FATIGUE (She feels beat, feels run down, feels tired). At the time of the report, MUSCULOSKELETAL STIFFNESS (Right after the shot, she felt stiffness in both arms and across the shoulders.), DYSGEUSIA (She also had metal taste in her mouth.), FEELING ABNORMAL (She also feels some sinus issues but it is very minor/ her system is warning her down), UPPER-AIRWAY COUGH SYNDROME (She has nasal drip but always has that. She just feels like her system is waring her down.), FEELING COLD (She feels like she has a cold) and FATIGUE (She feels beat, feels run down, feels tired) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: TCR received contains non significant information.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and VERTIGO (vertigo) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (dizziness) and VERTIGO (vertigo). At the time of the report, DIZZINESS (dizziness) and VERTIGO (vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took more water as treatment.   This case was linked to US-MODERNATX, INC.-MOD-2021-073850 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional info-2 : To confirm NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073850:Patient's friend case
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Gait disturbance, Pain in extremity, Peripheral swelling
Clinical narrative: left foot got swollen and purple; pain in leg; can't put a shoe neither walk; foot hot as fire; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left foot got swollen and purple), PAIN IN EXTREMITY (pain in leg), GAIT DISTURBANCE (can't put a shoe neither walk) and BURNING SENSATION (foot hot as fire) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A2114) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 PERIPHERAL SWELLING (left foot got swollen and purple), PAIN IN EXTREMITY (pain in leg), GAIT DISTURBANCE (can't put a shoe neither walk) and BURNING SENSATION (foot hot as fire). At the time of the report, PERIPHERAL SWELLING (left foot got swollen and purple), PAIN IN EXTREMITY (pain in leg), GAIT DISTURBANCE (can't put a shoe neither walk) and BURNING SENSATION (foot hot as fire) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  The treatment medication was Ibuprofen.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Ringing in ears within 2 hours; Dizziness on lying down; Low BP; Feels as if heart is racing; Diarrhea; has sore arm; Tired, energy levels too low; Sweating; Legs feel heavy and tired, Too hard to do little work; Red spots at injection site with soreness; Red spots at injection site with soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears within 2 hours), DIZZINESS (Dizziness on lying down), HYPOTENSION (Low BP), HEART RATE ABNORMAL (Feels as if heart is racing) and DIARRHOEA (Diarrhea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Meniere's disease.    On 18-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 TINNITUS (Ringing in ears within 2 hours), DIZZINESS (Dizziness on lying down), HYPOTENSION (Low BP), HEART RATE ABNORMAL (Feels as if heart is racing), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (has sore arm), ASTHENIA (Tired, energy levels too low), HYPERHIDROSIS (Sweating), FATIGUE (Legs feel heavy and tired, Too hard to do little work), VACCINATION SITE PAIN (Red spots at injection site with soreness), VACCINATION SITE ERYTHEMA (Red spots at injection site with soreness) and HEADACHE (Headache). At the time of the report, TINNITUS (Ringing in ears within 2 hours), DIZZINESS (Dizziness on lying down), HYPOTENSION (Low BP), HEART RATE ABNORMAL (Feels as if heart is racing), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (has sore arm), ASTHENIA (Tired, energy levels too low), HYPERHIDROSIS (Sweating), FATIGUE (Legs feel heavy and tired, Too hard to do little work), VACCINATION SITE PAIN (Red spots at injection site with soreness), VACCINATION SITE ERYTHEMA (Red spots at injection site with soreness) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (120-80 mmHg): 95/59 mmHg (Low) decreased blood pressure.. On an unknown date, Heart rate (80-100): 70 (Low) decreased pulse rate..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: follow-up was received on 2 June 2021.batch number updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate abnormal, Hyperhidrosis, Hypotension
Clinical narrative: Ringing in ears within 2 hours; Dizziness on lying down; Low BP; Feels as if heart is racing; Diarrhea; has sore arm; Tired, energy levels too low; Sweating; Legs feel heavy and tired, Too hard to do little work; Red spots at injection site with soreness; Red spots at injection site with soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears within 2 hours), DIZZINESS (Dizziness on lying down), HYPOTENSION (Low BP), HEART RATE ABNORMAL (Feels as if heart is racing) and DIARRHOEA (Diarrhea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Meniere's disease.    On 18-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 TINNITUS (Ringing in ears within 2 hours), DIZZINESS (Dizziness on lying down), HYPOTENSION (Low BP), HEART RATE ABNORMAL (Feels as if heart is racing), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (has sore arm), ASTHENIA (Tired, energy levels too low), HYPERHIDROSIS (Sweating), FATIGUE (Legs feel heavy and tired, Too hard to do little work), VACCINATION SITE PAIN (Red spots at injection site with soreness), VACCINATION SITE ERYTHEMA (Red spots at injection site with soreness) and HEADACHE (Headache). At the time of the report, TINNITUS (Ringing in ears within 2 hours), DIZZINESS (Dizziness on lying down), HYPOTENSION (Low BP), HEART RATE ABNORMAL (Feels as if heart is racing), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (has sore arm), ASTHENIA (Tired, energy levels too low), HYPERHIDROSIS (Sweating), FATIGUE (Legs feel heavy and tired, Too hard to do little work), VACCINATION SITE PAIN (Red spots at injection site with soreness), VACCINATION SITE ERYTHEMA (Red spots at injection site with soreness) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (120-80 mmHg): 95/59 mmHg (Low) decreased blood pressure.. On an unknown date, Heart rate (80-100): 70 (Low) decreased pulse rate..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: follow-up was received on 2 June 2021.batch number updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tinnitus, Vaccination site erythema, Vaccination site pain
Clinical narrative: Ringing in ears within 2 hours; Dizziness on lying down; Low BP; Feels as if heart is racing; Diarrhea; has sore arm; Tired, energy levels too low; Sweating; Legs feel heavy and tired, Too hard to do little work; Red spots at injection site with soreness; Red spots at injection site with soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears within 2 hours), DIZZINESS (Dizziness on lying down), HYPOTENSION (Low BP), HEART RATE ABNORMAL (Feels as if heart is racing) and DIARRHOEA (Diarrhea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Meniere's disease.    On 18-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 TINNITUS (Ringing in ears within 2 hours), DIZZINESS (Dizziness on lying down), HYPOTENSION (Low BP), HEART RATE ABNORMAL (Feels as if heart is racing), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (has sore arm), ASTHENIA (Tired, energy levels too low), HYPERHIDROSIS (Sweating), FATIGUE (Legs feel heavy and tired, Too hard to do little work), VACCINATION SITE PAIN (Red spots at injection site with soreness), VACCINATION SITE ERYTHEMA (Red spots at injection site with soreness) and HEADACHE (Headache). At the time of the report, TINNITUS (Ringing in ears within 2 hours), DIZZINESS (Dizziness on lying down), HYPOTENSION (Low BP), HEART RATE ABNORMAL (Feels as if heart is racing), DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (has sore arm), ASTHENIA (Tired, energy levels too low), HYPERHIDROSIS (Sweating), FATIGUE (Legs feel heavy and tired, Too hard to do little work), VACCINATION SITE PAIN (Red spots at injection site with soreness), VACCINATION SITE ERYTHEMA (Red spots at injection site with soreness) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (120-80 mmHg): 95/59 mmHg (Low) decreased blood pressure.. On an unknown date, Heart rate (80-100): 70 (Low) decreased pulse rate..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: follow-up was received on 2 June 2021.batch number updated.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: his arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (his arm was a little sore) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (his arm was a little sore). At the time of the report, VACCINATION SITE PAIN (his arm was a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided. no concomitant medication provided by reporter.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Urticaria
Clinical narrative: hives under her chin they are red and itchy; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives under her chin they are red and itchy), CHILLS (Chills) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21 and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On 10-Apr-2021, the patient experienced URTICARIA (hives under her chin they are red and itchy). On 10-Apr-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, URTICARIA (hives under her chin they are red and itchy) outcome was unknown.            No treatment was reported. No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Swelling
Clinical narrative: body is swollen; in the whole body, mostly on my shoulders, and i have like balls on my both; body ache on mi interior; Very bad headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (body is swollen), HEADACHE (Very bad headache), MYALGIA (Body ache), ARTHRALGIA (in the whole body, mostly on my shoulders, and i have like balls on my both) and MYALGIA (body ache on mi interior) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included THYROID for Thyroid disorder.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced HEADACHE (Very bad headache), MYALGIA (Body ache) and MYALGIA (body ache on mi interior). On 11-Apr-2021, the patient experienced SWELLING (body is swollen) and ARTHRALGIA (in the whole body, mostly on my shoulders, and i have like balls on my both). At the time of the report, SWELLING (body is swollen), HEADACHE (Very bad headache), MYALGIA (Body ache), ARTHRALGIA (in the whole body, mostly on my shoulders, and i have like balls on my both) and MYALGIA (body ache on mi interior) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is taking Tylenol since 10-Apr-2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Diarrhoea, Fatigue, Pain
Clinical narrative: withouth being able to get up; all the symptoms: body pain, back pain, diarrhea; all the symptoms: body pain, back pain, diarrhea; all the symptoms: body pain, back pain, diarrhea; Weakness; Lot of fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (all the symptoms: body pain, back pain, diarrhea), BACK PAIN (all the symptoms: body pain, back pain, diarrhea), DIARRHOEA (all the symptoms: body pain, back pain, diarrhea), ASTHENIA (Weakness) and PYREXIA (Lot of fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced ASTHENIA (Weakness) and PYREXIA (Lot of fever). On 11-Apr-2021, the patient experienced PAIN (all the symptoms: body pain, back pain, diarrhea), BACK PAIN (all the symptoms: body pain, back pain, diarrhea) and DIARRHOEA (all the symptoms: body pain, back pain, diarrhea). On an unknown date, the patient experienced FATIGUE (withouth being able to get up). At the time of the report, PAIN (all the symptoms: body pain, back pain, diarrhea), BACK PAIN (all the symptoms: body pain, back pain, diarrhea), DIARRHOEA (all the symptoms: body pain, back pain, diarrhea), ASTHENIA (Weakness), PYREXIA (Lot of fever) and FATIGUE (withouth being able to get up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: follow-up received on 13-APR-2021, contain no significant information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: withouth being able to get up; all the symptoms: body pain, back pain, diarrhea; all the symptoms: body pain, back pain, diarrhea; all the symptoms: body pain, back pain, diarrhea; Weakness; Lot of fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (all the symptoms: body pain, back pain, diarrhea), BACK PAIN (all the symptoms: body pain, back pain, diarrhea), DIARRHOEA (all the symptoms: body pain, back pain, diarrhea), ASTHENIA (Weakness) and PYREXIA (Lot of fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced ASTHENIA (Weakness) and PYREXIA (Lot of fever). On 11-Apr-2021, the patient experienced PAIN (all the symptoms: body pain, back pain, diarrhea), BACK PAIN (all the symptoms: body pain, back pain, diarrhea) and DIARRHOEA (all the symptoms: body pain, back pain, diarrhea). On an unknown date, the patient experienced FATIGUE (withouth being able to get up). At the time of the report, PAIN (all the symptoms: body pain, back pain, diarrhea), BACK PAIN (all the symptoms: body pain, back pain, diarrhea), DIARRHOEA (all the symptoms: body pain, back pain, diarrhea), ASTHENIA (Weakness), PYREXIA (Lot of fever) and FATIGUE (withouth being able to get up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: follow-up received on 13-APR-2021, contain no significant information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: big red itchy rash on the thighs; big red itchy rash on the thighs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (big red itchy rash on the thighs) and PRURITUS (big red itchy rash on the thighs) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced RASH (big red itchy rash on the thighs). On an unknown date, the patient experienced PRURITUS (big red itchy rash on the thighs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH (big red itchy rash on the thighs) and PRURITUS (big red itchy rash on the thighs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.