chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Mouth swelling, Swollen tongue
Clinical narrative: Swollen mouth; Swollen tongue; Rapid pulse; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Swollen mouth), SWOLLEN TONGUE (Swollen tongue) and HEART RATE INCREASED (Rapid pulse) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included LORATADINE (CLARITINE) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced MOUTH SWELLING (Swollen mouth), SWOLLEN TONGUE (Swollen tongue) and HEART RATE INCREASED (Rapid pulse). The patient was treated with DIPHENHYDRAMINE ongoing since an unknown date at a dose of 1 dosage form. On 09-Mar-2021, HEART RATE INCREASED (Rapid pulse) had resolved. On 11-Mar-2021, MOUTH SWELLING (Swollen mouth) and SWOLLEN TONGUE (Swollen tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Headache, Pyrexia
Clinical narrative: Tested positive for Corona virus; Headache; fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Corona virus), HEADACHE (Headache), PYREXIA (fever) and CHILLS (Chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (fever) and CHILLS (Chills). On 11-Mar-2021, the patient experienced COVID-19 (Tested positive for Corona virus). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Corona virus), HEADACHE (Headache), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 102f (Inconclusive) fever with 102 Fahrenheits. On 11-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Corona virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Tested positive for Corona virus; Headache; fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Corona virus), HEADACHE (Headache), PYREXIA (fever) and CHILLS (Chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (fever) and CHILLS (Chills). On 11-Mar-2021, the patient experienced COVID-19 (Tested positive for Corona virus). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Corona virus), HEADACHE (Headache), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 102f (Inconclusive) fever with 102 Fahrenheits. On 11-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Corona virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: redness; Soreness in arm; hot to touch; extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PAIN IN EXTREMITY (Soreness in arm), FEELING HOT (hot to touch) and PRURITUS (extremely itchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), PAIN IN EXTREMITY (Soreness in arm), FEELING HOT (hot to touch) and PRURITUS (extremely itchy). At the time of the report, ERYTHEMA (redness), PAIN IN EXTREMITY (Soreness in arm), FEELING HOT (hot to touch) and PRURITUS (extremely itchy) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient got covid-19 after the first dose of the vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Patient got covid-19 after the first dose of the vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient got covid-19 after the first dose of the vaccine.). At the time of the report, COVID-19 (Patient got covid-19 after the first dose of the vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Fatigue, Rash, Rhinorrhoea
Clinical narrative: Rash is red and looks pimple-like; Slight running nose; Chicken pox type rash all over her entire body (arms, chest, stomach, back, legs); Patient feels tired; This spontaneous case was reported by an other health care professional and describes the occurrence of DERMATITIS ACNEIFORM (Rash is red and looks pimple-like), RHINORRHOEA (Slight running nose), RASH (Chicken pox type rash all over her entire body (arms, chest, stomach, back, legs)) and FATIGUE (Patient feels tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DERMATITIS ACNEIFORM (Rash is red and looks pimple-like), RHINORRHOEA (Slight running nose), RASH (Chicken pox type rash all over her entire body (arms, chest, stomach, back, legs)) and FATIGUE (Patient feels tired). At the time of the report, DERMATITIS ACNEIFORM (Rash is red and looks pimple-like), RHINORRHOEA (Slight running nose), RASH (Chicken pox type rash all over her entire body (arms, chest, stomach, back, legs)) and FATIGUE (Patient feels tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  At the time of the report the patient had not administered any treatment however, the pharmacist recommended the patient administer Benadryl as treatment for the events.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: Sore arm; Red spot on arm; Warm; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red spot on arm), FEELING HOT (Warm) and PRURITUS (Itching) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red spot on arm), FEELING HOT (Warm) and PRURITUS (Itching). At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (Red spot on arm), FEELING HOT (Warm) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant and received the Moderna COVID 19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna COVID 19 vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 31-Dec-2020 and the estimated date of delivery was 07-Oct-2021. On 05-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna COVID 19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 05-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the Moderna COVID 19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Lethargy, Myalgia, Pain, Pyrexia
Clinical narrative: pain; Violently throwing up; Shortness of breath; very lethargic; very achy; temperature of 102.5/fever; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN (pain), LETHARGY (very lethargic), MYALGIA (very achy) and PYREXIA (temperature of 102.5/fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included APIXABAN (ELIQUIS), METHOTREXATE and PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), LETHARGY (very lethargic), MYALGIA (very achy) and PYREXIA (temperature of 102.5/fever). On 12-Mar-2021, the patient experienced PAIN (pain) and VOMITING (Violently throwing up). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), LETHARGY (very lethargic) and MYALGIA (very achy) outcome was unknown and PAIN (pain), PYREXIA (temperature of 102.5/fever) and VOMITING (Violently throwing up) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: pain; Violently throwing up; Shortness of breath; very lethargic; very achy; temperature of 102.5/fever; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN (pain), LETHARGY (very lethargic), MYALGIA (very achy) and PYREXIA (temperature of 102.5/fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included APIXABAN (ELIQUIS), METHOTREXATE and PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), LETHARGY (very lethargic), MYALGIA (very achy) and PYREXIA (temperature of 102.5/fever). On 12-Mar-2021, the patient experienced PAIN (pain) and VOMITING (Violently throwing up). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), LETHARGY (very lethargic) and MYALGIA (very achy) outcome was unknown and PAIN (pain), PYREXIA (temperature of 102.5/fever) and VOMITING (Violently throwing up) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Muscular weakness, Pyrexia, Urinary incontinence
Clinical narrative: weakness in the legs; flushiness in the face; incontinence of urine; Low grade fever; extreme fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCULAR WEAKNESS (weakness in the legs), FLUSHING (flushiness in the face), URINARY INCONTINENCE (incontinence of urine), PYREXIA (Low grade fever) and FATIGUE (extreme fatigue) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bedridden and Walker user.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the legs), FLUSHING (flushiness in the face), URINARY INCONTINENCE (incontinence of urine), PYREXIA (Low grade fever) and FATIGUE (extreme fatigue). At the time of the report, MUSCULAR WEAKNESS (weakness in the legs), FLUSHING (flushiness in the face), URINARY INCONTINENCE (incontinence of urine), PYREXIA (Low grade fever) and FATIGUE (extreme fatigue) had resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant and treatment medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up was received on 04-MAY-2021. All reported events' outcome were updated to recovered/resolved.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Mouth swelling, Pharyngeal swelling, Rhinorrhoea
Clinical narrative: throat swelling; mouth swelling; running nose; coughs; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat swelling), MOUTH SWELLING (mouth swelling), RHINORRHOEA (running nose), COUGH (coughs) and VOMITING (vomiting) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-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 12-Mar-2021, the patient experienced PHARYNGEAL SWELLING (throat swelling), MOUTH SWELLING (mouth swelling), RHINORRHOEA (running nose), COUGH (coughs), VOMITING (vomiting) and CHILLS (chills). At the time of the report, PHARYNGEAL SWELLING (throat swelling), MOUTH SWELLING (mouth swelling), RHINORRHOEA (running nose), COUGH (coughs), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: throat swelling; mouth swelling; running nose; coughs; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat swelling), MOUTH SWELLING (mouth swelling), RHINORRHOEA (running nose), COUGH (coughs) and VOMITING (vomiting) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-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 12-Mar-2021, the patient experienced PHARYNGEAL SWELLING (throat swelling), MOUTH SWELLING (mouth swelling), RHINORRHOEA (running nose), COUGH (coughs), VOMITING (vomiting) and CHILLS (chills). At the time of the report, PHARYNGEAL SWELLING (throat swelling), MOUTH SWELLING (mouth swelling), RHINORRHOEA (running nose), COUGH (coughs), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Administered with 2 doses of the vaccine 5 minutes apart; A spontaneous report was received from a physician concerning a (patient age and gender: unknown)patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  was administered with 2 doses of the vaccine 5 minutes apart/Inappropriate schedule of vaccine administered  The patient's medical history was not reported. Concomitant medications taken by the patient were not provided.  On an unknown date, prior to the onset of the event, the patient received their planned doses of mRNA-1273 (Lot number: unknown) through unknown route at unspecified site for prophylaxis of COVID-19 infection.  On an unknown date, the reporter reported that patient was administered with 2 doses of the Moderna Covid-19 vaccine 5 minutes apart on the same arm.  Treatment activities for event was unknown.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event administered with 2 doses of the Moderna Covid-19 vaccine 5 minutes apart  was resolved on an unknown date.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273, lot # unknown  with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: feeling tired; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (feeling tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 12-Mar-2021, the patient experienced FATIGUE (feeling tired). On 11-Mar-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pruritus, Pyrexia
Clinical narrative: Longer itching; fever 99.1 or 99.2; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Longer itching) and PYREXIA (fever 99.1 or 99.2) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013a21a and 004m20a) for COVID-19 vaccination.     Concomitant products included METFORMIN, SITAGLIPTIN (JANUVIA [SITAGLIPTIN]), ALLOPURINOL, LEVOTHYROXINE, LISINOPRIL, ATORVASTATIN and ESOMEPRAZOLE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Longer itching) and PYREXIA (fever 99.1 or 99.2). At the time of the report, PRURITUS (Longer itching) and PYREXIA (fever 99.1 or 99.2) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: (High) 99.1 or 99.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (chills) and HEADACHE (headaches). At the time of the report, CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Disorientation, Dysgeusia, Glossodynia, Headache
Clinical narrative: Tightness in the chest; Sinus congestion; Headache; tongue felt tender; Metal taste; felt disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (felt disoriented), GLOSSODYNIA (tongue felt tender), DYSGEUSIA (Metal taste), CHEST DISCOMFORT (Tightness in the chest) and SINUS CONGESTION (Sinus congestion) in a 49-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 Allergy to antibiotic (Allergic to amoxicillin).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DISORIENTATION (felt disoriented). On 10-Mar-2021, the patient experienced GLOSSODYNIA (tongue felt tender), DYSGEUSIA (Metal taste) and HEADACHE (Headache). 10-Mar-2021, the patient experienced SINUS CONGESTION (Sinus congestion). On 12-Mar-2021, the patient experienced CHEST DISCOMFORT (Tightness in the chest). At the time of the report, DISORIENTATION (felt disoriented), GLOSSODYNIA (tongue felt tender), DYSGEUSIA (Metal taste), CHEST DISCOMFORT (Tightness in the chest), SINUS CONGESTION (Sinus congestion) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  It was reported that no medical attention was pursued and did not self medicate with any over-the-counter medications.  No concomitant medications were  reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: Tightness in the chest; Sinus congestion; Headache; tongue felt tender; Metal taste; felt disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (felt disoriented), GLOSSODYNIA (tongue felt tender), DYSGEUSIA (Metal taste), CHEST DISCOMFORT (Tightness in the chest) and SINUS CONGESTION (Sinus congestion) in a 49-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 Allergy to antibiotic (Allergic to amoxicillin).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DISORIENTATION (felt disoriented). On 10-Mar-2021, the patient experienced GLOSSODYNIA (tongue felt tender), DYSGEUSIA (Metal taste) and HEADACHE (Headache). 10-Mar-2021, the patient experienced SINUS CONGESTION (Sinus congestion). On 12-Mar-2021, the patient experienced CHEST DISCOMFORT (Tightness in the chest). At the time of the report, DISORIENTATION (felt disoriented), GLOSSODYNIA (tongue felt tender), DYSGEUSIA (Metal taste), CHEST DISCOMFORT (Tightness in the chest), SINUS CONGESTION (Sinus congestion) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  It was reported that no medical attention was pursued and did not self medicate with any over-the-counter medications.  No concomitant medications were  reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness after vaccine and is getting worse; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness after vaccine and is getting worse) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 623M20A and 623M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (Dizziness after vaccine and is getting worse). At the time of the report, DIZZINESS (Dizziness after vaccine and is getting worse) had not resolved.            No concomitant medications were reported.   No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Pain, Streptobacillus test positive
Clinical narrative: Body aches; Dizziness; Throbbing in joints; Headaches; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of PAIN (Body aches), DIZZINESS (Dizziness), ARTHRALGIA (Throbbing in joints) and HEADACHE (Headaches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced PAIN (Body aches), DIZZINESS (Dizziness), ARTHRALGIA (Throbbing in joints) and HEADACHE (Headaches). The delivery occurred  on 28-Feb-2021. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, PAIN (Body aches), DIZZINESS (Dizziness), ARTHRALGIA (Throbbing in joints) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Streptobacillus test positive: unknown (Positive) tested positive for strep B.    Action taken with mRNA-1273 in response to the event was not applicable.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma. Concomitant products included CARBAMAZEPINE (TEGRETOL), ASCORBIC ACID (VITAMIIN C), TIMOLOL, BRIMONIDINE TARTRATE (ALPHAGAN), PILOCARPINE, ALBUTEROL SULFATE, AMLODIPINE and LISINOPRIL for an unknown indication.    On 17-Feb-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 DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was reported to have dizziness before first dose of vaccine after which it got worse.  Patient was advised to take meclizine by her HCP but she did not as she investigated it may worsen her glaucoma.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Muscle spasms
Clinical narrative: Bad Body Aches; Legs Hurting/Leg pain ful to touch; Leg cramps; Leg tingling; hard time sleeping; Bad Muscle Aches; Fever; headaches; Fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bad Body Aches), PAIN IN EXTREMITY (Legs Hurting/Leg pain ful to touch), MUSCLE SPASMS (Leg cramps), PARAESTHESIA (Leg tingling) and INSOMNIA (hard time sleeping) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Bad Body Aches), PAIN IN EXTREMITY (Legs Hurting/Leg pain ful to touch), MUSCLE SPASMS (Leg cramps), PARAESTHESIA (Leg tingling), INSOMNIA (hard time sleeping), MYALGIA (Bad Muscle Aches), PYREXIA (Fever), HEADACHE (headaches), FATIGUE (Fatigue) and CHILLS (chills). At the time of the report, PAIN (Bad Body Aches), PAIN IN EXTREMITY (Legs Hurting/Leg pain ful to touch), MUSCLE SPASMS (Leg cramps), PARAESTHESIA (Leg tingling), INSOMNIA (hard time sleeping), MYALGIA (Bad Muscle Aches), PYREXIA (Fever), HEADACHE (headaches), FATIGUE (Fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided Treatment information was not provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Bad Body Aches; Legs Hurting/Leg pain ful to touch; Leg cramps; Leg tingling; hard time sleeping; Bad Muscle Aches; Fever; headaches; Fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bad Body Aches), PAIN IN EXTREMITY (Legs Hurting/Leg pain ful to touch), MUSCLE SPASMS (Leg cramps), PARAESTHESIA (Leg tingling) and INSOMNIA (hard time sleeping) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Bad Body Aches), PAIN IN EXTREMITY (Legs Hurting/Leg pain ful to touch), MUSCLE SPASMS (Leg cramps), PARAESTHESIA (Leg tingling), INSOMNIA (hard time sleeping), MYALGIA (Bad Muscle Aches), PYREXIA (Fever), HEADACHE (headaches), FATIGUE (Fatigue) and CHILLS (chills). At the time of the report, PAIN (Bad Body Aches), PAIN IN EXTREMITY (Legs Hurting/Leg pain ful to touch), MUSCLE SPASMS (Leg cramps), PARAESTHESIA (Leg tingling), INSOMNIA (hard time sleeping), MYALGIA (Bad Muscle Aches), PYREXIA (Fever), HEADACHE (headaches), FATIGUE (Fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided Treatment information was not provided.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Walking aid user
Clinical narrative: cannot walk without a severe limb; still has pain in the left hip and cant walk without a limp or cane; pain in both knees especially the left knee and both sides of hip; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (cannot walk without a severe limb), WALKING AID USER (still has pain in the left hip and cant walk without a limp or cane) and ARTHRALGIA (pain in both knees especially the left knee and both sides of hip) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A or 038K20A and 031M20A or 038K20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis, Diabetes and Surgery. Concurrent medical conditions included Limping.   On 02-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 an unknown date, the patient experienced GAIT DISTURBANCE (cannot walk without a severe limb), WALKING AID USER (still has pain in the left hip and cant walk without a limp or cane) and ARTHRALGIA (pain in both knees especially the left knee and both sides of hip). On 12-Mar-2021, ARTHRALGIA (pain in both knees especially the left knee and both sides of hip) had not resolved. At the time of the report, GAIT DISTURBANCE (cannot walk without a severe limb) and WALKING AID USER (still has pain in the left hip and cant walk without a limp or cane) outcome was unknown.            No Concomitant medications were provided Reporter provided two lot numbers but was not sure which one is for dose one and dose two. Lot#:031M20A or 038K20A No Treatment information provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Vaccination Site Erythema; Vaccination Site Rash; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (Vaccination Site Erythema) and VACCINATION SITE RASH (Vaccination Site Rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VALACYCLOVIR [VALACICLOVIR], ROSUVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination Site Erythema) and VACCINATION SITE RASH (Vaccination Site Rash). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (Vaccination Site Erythema) and VACCINATION SITE RASH (Vaccination Site Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Lymph node pain, Pain in extremity, Paraesthesia
Clinical narrative: Lymph node hurts.; felt tingling at the injection site; Arm hurting; Slept longer than she normal; Tingling in her left fingers, face and cheek on the left side; Felt very exhausted; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (felt tingling at the injection site), PAIN IN EXTREMITY (Arm hurting), HYPERSOMNIA (Slept longer than she normal), PARAESTHESIA (Tingling in her left fingers, face and cheek on the left side) and FATIGUE (Felt very exhausted) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Optic neuritis.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (felt tingling at the injection site), PAIN IN EXTREMITY (Arm hurting), HYPERSOMNIA (Slept longer than she normal), PARAESTHESIA (Tingling in her left fingers, face and cheek on the left side) and FATIGUE (Felt very exhausted). On 12-Mar-2021, the patient experienced LYMPH NODE PAIN (Lymph node hurts.). At the time of the report, VACCINATION SITE PARAESTHESIA (felt tingling at the injection site), PAIN IN EXTREMITY (Arm hurting), HYPERSOMNIA (Slept longer than she normal), PARAESTHESIA (Tingling in her left fingers, face and cheek on the left side), FATIGUE (Felt very exhausted) and LYMPH NODE PAIN (Lymph node hurts.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       As a corrective patient was laid down with feet up and was given water. Concomitant medication use was unknown Treatment information was unknown
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site paraesthesia
Clinical narrative: Lymph node hurts.; felt tingling at the injection site; Arm hurting; Slept longer than she normal; Tingling in her left fingers, face and cheek on the left side; Felt very exhausted; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (felt tingling at the injection site), PAIN IN EXTREMITY (Arm hurting), HYPERSOMNIA (Slept longer than she normal), PARAESTHESIA (Tingling in her left fingers, face and cheek on the left side) and FATIGUE (Felt very exhausted) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Optic neuritis.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (felt tingling at the injection site), PAIN IN EXTREMITY (Arm hurting), HYPERSOMNIA (Slept longer than she normal), PARAESTHESIA (Tingling in her left fingers, face and cheek on the left side) and FATIGUE (Felt very exhausted). On 12-Mar-2021, the patient experienced LYMPH NODE PAIN (Lymph node hurts.). At the time of the report, VACCINATION SITE PARAESTHESIA (felt tingling at the injection site), PAIN IN EXTREMITY (Arm hurting), HYPERSOMNIA (Slept longer than she normal), PARAESTHESIA (Tingling in her left fingers, face and cheek on the left side), FATIGUE (Felt very exhausted) and LYMPH NODE PAIN (Lymph node hurts.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       As a corrective patient was laid down with feet up and was given water. Concomitant medication use was unknown Treatment information was unknown
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Stool analysis
Clinical narrative: Severe diarrhea, a lower GI problem (got worse after the second); This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Severe diarrhea, a lower GI problem (got worse after the second)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), LEVOTHYROXINE for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced DIARRHOEA (Severe diarrhea, a lower GI problem (got worse after the second)). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Discomfort abdominal, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Severe diarrhea, a lower GI problem (got worse after the second)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Stool analysis: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 moderna vaccine was not applicable. Patient takes two blood pressure medications as concomitant medications. Treatment included Pepto Bismo but it did not really help.   This case was linked to US-MODERNATX, INC.-MOD-2021-040930 (E2B Linked Report). This case was linked to MOD-2021-076873 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Lab data and outcome for the event was added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-040930:Same reported/different patient (Husband case)
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Pruritus, Pyrexia, SARS-CoV-2 antibody test negative
Clinical narrative: Itching/pruritis/itchy bumps; fever; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Itching/pruritis/itchy bumps) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028120A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis and Surgery (Sigmoid colon resection) on 26-May-2021. Concurrent medical conditions included Asthma, Allergy, Penicillin allergy, Fish allergy (regurgitation requires hospitalization and IV's), Allergy (Pine nuts allergy cause swollen tongue and lips) and Drug allergy (Anti inflammatory drugs (Mobic, Advil) cause flu like sysmtoms). Concomitant products included CALCIUM CITRATE, COLECALCIFEROL (CALCITRATE PLUS D) for Calcium, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Nose congestion, BIFIDOBACTERIUM ANIMALIS, LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS BIFIDUS) for Probiotic therapy, LEVOTHYROXINE SODIUM (SYNTHROID) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (Itching/pruritis/itchy bumps). In March 2021, the patient experienced PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) (oral) in February 2021 for Fever, at an unspecified dose and frequency. On 24-Mar-2021, PRURITUS (Itching/pruritis/itchy bumps) had resolved. At the time of the report, PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: 160/80 (High) 160/80 mm/Hg. On 11-Mar-2021, SARS-CoV-2 antibody test negative: negative (Inconclusive) Vaccine provided no protection because no antibodies were found. On an unknown date, Body temperature: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRURITUS (Itching/pruritis/itchy bumps) and PYREXIA (fever) to be possibly related.    Patient reported after the second shot on 17 Feb 2021, she had a fever that  lasted about 24-30 hours.  She took  Tylenol for it.  Patient reported she had three weeks of itchy bumps that started on 03 Mar 2021 after getting the second vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow-up received and update relevant history ,lab data, concomitant medication and addition of second dose On 14-Jul-2021: Follow-up received and contain non-significant information. On 22-Jul-2021: Follow-up received and contain non-significant information.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Special Population : younger than 18 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Special Population : younger than 18 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event reported).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Special Population : younger than 18 years old). On 12-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Special Population : younger than 18 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported