chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Illness
Clinical narrative: not feeling good; dizzy; in bed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (not feeling good), DIZZINESS (dizzy) and FATIGUE (in bed) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced ILLNESS (not feeling good), DIZZINESS (dizzy) and FATIGUE (in bed). At the time of the report, ILLNESS (not feeling good), DIZZINESS (dizzy) and FATIGUE (in bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Affected area greater than quarter on 25/Mar/2021; Affected area smaller than quarter on 24/Mar/2021; Redness at injection site which is hot; Itching on arm; Hardness at injection site; Swelling at injection site; Injection site is hot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on arm), VACCINATION SITE REACTION (Affected area greater than quarter on 25/Mar/2021), VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE REACTION (Affected area smaller than quarter on 24/Mar/2021) and VACCINATION SITE INDURATION (Hardness at injection site) in a 42-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 Allergy to antibiotic (allergy to cipro).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (Itching on arm), VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 24-Mar-2021, the patient experienced VACCINATION SITE REACTION (Affected area smaller than quarter on 24/Mar/2021) and VACCINATION SITE ERYTHEMA (Redness at injection site which is hot). On 25-Mar-2021, the patient experienced VACCINATION SITE REACTION (Affected area greater than quarter on 25/Mar/2021). At the time of the report, PRURITUS (Itching on arm), VACCINATION SITE REACTION (Affected area greater than quarter on 25/Mar/2021), VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE REACTION (Affected area smaller than quarter on 24/Mar/2021), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site which is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Affected area greater than quarter on 25/Mar/2021; Affected area smaller than quarter on 24/Mar/2021; Redness at injection site which is hot; Itching on arm; Hardness at injection site; Swelling at injection site; Injection site is hot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on arm), VACCINATION SITE REACTION (Affected area greater than quarter on 25/Mar/2021), VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE REACTION (Affected area smaller than quarter on 24/Mar/2021) and VACCINATION SITE INDURATION (Hardness at injection site) in a 42-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 Allergy to antibiotic (allergy to cipro).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (Itching on arm), VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). On 24-Mar-2021, the patient experienced VACCINATION SITE REACTION (Affected area smaller than quarter on 24/Mar/2021) and VACCINATION SITE ERYTHEMA (Redness at injection site which is hot). On 25-Mar-2021, the patient experienced VACCINATION SITE REACTION (Affected area greater than quarter on 25/Mar/2021). At the time of the report, PRURITUS (Itching on arm), VACCINATION SITE REACTION (Affected area greater than quarter on 25/Mar/2021), VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE REACTION (Affected area smaller than quarter on 24/Mar/2021), VACCINATION SITE INDURATION (Hardness at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site which is hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site mass
Clinical narrative: Arm sore after 1st dose; Could feel a knot after 1st dose; Redness moving down arm after 1st dose; Arm felt thick after 1st dose; Big red spot on arm after 1st dose; Arm itching after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore after 1st dose), VACCINATION SITE MASS (Could feel a knot after 1st dose), ERYTHEMA (Redness moving down arm after 1st dose), VACCINATION SITE INDURATION (Arm felt thick after 1st dose) and VACCINATION SITE ERYTHEMA (Big red spot on arm after 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore after 1st dose), VACCINATION SITE MASS (Could feel a knot after 1st dose), ERYTHEMA (Redness moving down arm after 1st dose), VACCINATION SITE INDURATION (Arm felt thick after 1st dose), VACCINATION SITE ERYTHEMA (Big red spot on arm after 1st dose) and VACCINATION SITE PRURITUS (Arm itching after 1st dose). At the time of the report, PAIN IN EXTREMITY (Arm sore after 1st dose), ERYTHEMA (Redness moving down arm after 1st dose) and VACCINATION SITE PRURITUS (Arm itching after 1st dose) outcome was unknown, VACCINATION SITE MASS (Could feel a knot after 1st dose) and VACCINATION SITE INDURATION (Arm felt thick after 1st dose) had resolved and VACCINATION SITE ERYTHEMA (Big red spot on arm after 1st dose) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Arm sore after 1st dose; Could feel a knot after 1st dose; Redness moving down arm after 1st dose; Arm felt thick after 1st dose; Big red spot on arm after 1st dose; Arm itching after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore after 1st dose), VACCINATION SITE MASS (Could feel a knot after 1st dose), ERYTHEMA (Redness moving down arm after 1st dose), VACCINATION SITE INDURATION (Arm felt thick after 1st dose) and VACCINATION SITE ERYTHEMA (Big red spot on arm after 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore after 1st dose), VACCINATION SITE MASS (Could feel a knot after 1st dose), ERYTHEMA (Redness moving down arm after 1st dose), VACCINATION SITE INDURATION (Arm felt thick after 1st dose), VACCINATION SITE ERYTHEMA (Big red spot on arm after 1st dose) and VACCINATION SITE PRURITUS (Arm itching after 1st dose). At the time of the report, PAIN IN EXTREMITY (Arm sore after 1st dose), ERYTHEMA (Redness moving down arm after 1st dose) and VACCINATION SITE PRURITUS (Arm itching after 1st dose) outcome was unknown, VACCINATION SITE MASS (Could feel a knot after 1st dose) and VACCINATION SITE INDURATION (Arm felt thick after 1st dose) had resolved and VACCINATION SITE ERYTHEMA (Big red spot on arm after 1st dose) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and FATIGUE (tired) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (tired). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications reported included Blood pressure medication(not specified).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Pain in extremity, Pyrexia
Clinical narrative: Arm sore; felt sick to stomach; diarrhea; temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), ABDOMINAL DISCOMFORT (felt sick to stomach), DIARRHOEA (diarrhea) and PYREXIA (temperature) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), ABDOMINAL DISCOMFORT (felt sick to stomach), DIARRHOEA (diarrhea) and PYREXIA (temperature). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. On 15-Feb-2021, PAIN IN EXTREMITY (Arm sore), ABDOMINAL DISCOMFORT (felt sick to stomach), DIARRHOEA (diarrhea) and PYREXIA (temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nausea) in a 121-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     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 HEADACHE (headache) and NAUSEA (nausea). At the time of the report, HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    This case was linked to MOD-2021-063213 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Headache, Myalgia
Clinical narrative: Shortness of Breath; Chest Pressure; Chills; Headache; muscle pain; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (Chest Pressure), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (Chest Pressure), CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle pain) and PYREXIA (slight fever). At the time of the report, DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (Chest Pressure), CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle pain) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Shortness of Breath; Chest Pressure; Chills; Headache; muscle pain; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (Chest Pressure), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (Chest Pressure), CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle pain) and PYREXIA (slight fever). At the time of the report, DYSPNOEA (Shortness of Breath), CHEST DISCOMFORT (Chest Pressure), CHILLS (Chills), HEADACHE (Headache), MYALGIA (muscle pain) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: both ankles swollen; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (both ankles swollen) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gout.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced JOINT SWELLING (both ankles swollen). At the time of the report, JOINT SWELLING (both ankles swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a history of blood word drawn that came back normal. No relevant concomitant medications were reported. No treatment information was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth at injection site; Swelling at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warmth at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, FLUOXETINE, MONTELUKAST SODIUM (SINGULAIR), LORATADINE, ZOLPIDEM TARTRATE (AMBIEN), ATORVASTATIN, VITAMIN D NOS and VITAMIN D3 for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced INJECTION SITE WARMTH (Warmth at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, INJECTION SITE WARMTH (Warmth at injection site), INJECTION SITE SWELLING (Swelling at injection site) and INJECTION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Very sick for 4 days after; Legs aching; No appetite; Shaking; Diarrhea; Lethargic for last 10 days; Vomiting; Chills; Temp over 102 until 3rd day; Very exhausted, fatigue for last 10 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking) and DIARRHOEA (Diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking), DIARRHOEA (Diarrhea), LETHARGY (Lethargic for last 10 days), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Temp over 102 until 3rd day) and FATIGUE (Very exhausted, fatigue for last 10 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. On 18-Mar-2021, PYREXIA (Temp over 102 until 3rd day) had resolved. On 19-Mar-2021, ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, LETHARGY (Lethargic for last 10 days) and FATIGUE (Very exhausted, fatigue for last 10 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Body temperature: 102 (High) Over 102 until 3rd day.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lethargy, Pain in extremity, Pyrexia, Tremor
Clinical narrative: Very sick for 4 days after; Legs aching; No appetite; Shaking; Diarrhea; Lethargic for last 10 days; Vomiting; Chills; Temp over 102 until 3rd day; Very exhausted, fatigue for last 10 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking) and DIARRHOEA (Diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking), DIARRHOEA (Diarrhea), LETHARGY (Lethargic for last 10 days), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Temp over 102 until 3rd day) and FATIGUE (Very exhausted, fatigue for last 10 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. On 18-Mar-2021, PYREXIA (Temp over 102 until 3rd day) had resolved. On 19-Mar-2021, ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, LETHARGY (Lethargic for last 10 days) and FATIGUE (Very exhausted, fatigue for last 10 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Body temperature: 102 (High) Over 102 until 3rd day.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Very sick for 4 days after; Legs aching; No appetite; Shaking; Diarrhea; Lethargic for last 10 days; Vomiting; Chills; Temp over 102 until 3rd day; Very exhausted, fatigue for last 10 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking) and DIARRHOEA (Diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking), DIARRHOEA (Diarrhea), LETHARGY (Lethargic for last 10 days), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Temp over 102 until 3rd day) and FATIGUE (Very exhausted, fatigue for last 10 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. On 18-Mar-2021, PYREXIA (Temp over 102 until 3rd day) had resolved. On 19-Mar-2021, ILLNESS (Very sick for 4 days after), PAIN IN EXTREMITY (Legs aching), DECREASED APPETITE (No appetite), TREMOR (Shaking), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, LETHARGY (Lethargic for last 10 days) and FATIGUE (Very exhausted, fatigue for last 10 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Body temperature: 102 (High) Over 102 until 3rd day.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood grouping, Blood pressure measurement, Hypertension, Hypoacusis
Clinical narrative: Pain from neck to arm; Changes in hearing; Blood pressure elevation of 150/90/blood pressure 140/80; Swollen face; Injection site pain; Rash down the arm; pain through out body/Muscle pain; Joint pain; fever on and off; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face) and INJECTION SITE PAIN (Injection site pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (asthma). Concurrent medical conditions included Allergy (allergies).    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 PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face), INJECTION SITE PAIN (Injection site pain), VACCINATION SITE RASH (Rash down the arm), MYALGIA (pain through out body/Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (fever on and off). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Sleep disorder, at an unspecified dose and frequency; METHYLPREDNISOLONE ACEPONATE (ADERVAN) for Sleep disorder, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. On 09-Mar-2021, VACCINATION SITE RASH (Rash down the arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face), INJECTION SITE PAIN (Injection site pain), MYALGIA (pain through out body/Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (fever on and off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood grouping: ab negative (Inconclusive) AB negative. On an unknown date, Blood pressure measurement: 150/90 (High) 150/90 then went back down to 140/80.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Pain in extremity, Pyrexia, Swelling face
Clinical narrative: Pain from neck to arm; Changes in hearing; Blood pressure elevation of 150/90/blood pressure 140/80; Swollen face; Injection site pain; Rash down the arm; pain through out body/Muscle pain; Joint pain; fever on and off; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face) and INJECTION SITE PAIN (Injection site pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (asthma). Concurrent medical conditions included Allergy (allergies).    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 PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face), INJECTION SITE PAIN (Injection site pain), VACCINATION SITE RASH (Rash down the arm), MYALGIA (pain through out body/Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (fever on and off). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Sleep disorder, at an unspecified dose and frequency; METHYLPREDNISOLONE ACEPONATE (ADERVAN) for Sleep disorder, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. On 09-Mar-2021, VACCINATION SITE RASH (Rash down the arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face), INJECTION SITE PAIN (Injection site pain), MYALGIA (pain through out body/Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (fever on and off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood grouping: ab negative (Inconclusive) AB negative. On an unknown date, Blood pressure measurement: 150/90 (High) 150/90 then went back down to 140/80.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Pain from neck to arm; Changes in hearing; Blood pressure elevation of 150/90/blood pressure 140/80; Swollen face; Injection site pain; Rash down the arm; pain through out body/Muscle pain; Joint pain; fever on and off; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face) and INJECTION SITE PAIN (Injection site pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (asthma). Concurrent medical conditions included Allergy (allergies).    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 PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face), INJECTION SITE PAIN (Injection site pain), VACCINATION SITE RASH (Rash down the arm), MYALGIA (pain through out body/Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (fever on and off). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Sleep disorder, at an unspecified dose and frequency; METHYLPREDNISOLONE ACEPONATE (ADERVAN) for Sleep disorder, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. On 09-Mar-2021, VACCINATION SITE RASH (Rash down the arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face), INJECTION SITE PAIN (Injection site pain), MYALGIA (pain through out body/Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (fever on and off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood grouping: ab negative (Inconclusive) AB negative. On an unknown date, Blood pressure measurement: 150/90 (High) 150/90 then went back down to 140/80.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arms/ Rash on chest/ Rash on neck; rash "all over"; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on arms/ Rash on chest/ Rash on neck) and RASH (rash "all over") in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM, COLECALCIFEROL (VIT D [COLECALCIFEROL]), MONTELUKAST SODIUM (SINGULAIR), ESCITALOPRAM OXALATE (LEXAPRO) and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Rash on arms/ Rash on chest/ Rash on neck) and RASH (rash "all over"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE us (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, RASH (Rash on arms/ Rash on chest/ Rash on neck) and RASH (rash "all over") outcome was unknown.            On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route for prophylaxis of COVID-19 infection.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Pain
Clinical narrative: dizziness especially when getting up from bed; mild achiness for a couple of days.; sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness especially when getting up from bed), PAIN (mild achiness for a couple of days.) and ARTHRALGIA (sore shoulder) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Neck surgery (The dizziness is possibly because of his neck- had 3 neck operations).    On 27-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 DIZZINESS (dizziness especially when getting up from bed), PAIN (mild achiness for a couple of days.) and ARTHRALGIA (sore shoulder). At the time of the report, DIZZINESS (dizziness especially when getting up from bed) outcome was unknown and PAIN (mild achiness for a couple of days.) and ARTHRALGIA (sore shoulder) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-120698 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021 AE follow up  pain and arthralgia event  outcome recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash pruritic
Clinical narrative: swelling of both arms; itchy rash on left arm that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on left arm that comes and goes) and PERIPHERAL SWELLING (swelling of both arms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced RASH PRURITIC (itchy rash on left arm that comes and goes). On 24-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling of both arms). On 24-Mar-2021, PERIPHERAL SWELLING (swelling of both arms) had resolved. At the time of the report, RASH PRURITIC (itchy rash on left arm that comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting). On 21-Mar-2021, PAIN IN EXTREMITY (arm was hurting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Pyrexia
Clinical narrative: Digestive problems; Temperature of 100°F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Digestive problems), PYREXIA (Temperature of 100°F) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced DYSPEPSIA (Digestive problems), PYREXIA (Temperature of 100°F) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) on 24-Mar-2021 for Fever, at an unspecified dose and frequency. On 24-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, DYSPEPSIA (Digestive problems) and PYREXIA (Temperature of 100°F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: redness; soreness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness) and PAIN IN EXTREMITY (soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ERYTHEMA (redness) and PAIN IN EXTREMITY (soreness). At the time of the report, ERYTHEMA (redness) and PAIN IN EXTREMITY (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruise on the site of injection which is about 4inches long; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise on the site of injection which is about 4inches long) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced CONTUSION (Bruise on the site of injection which is about 4inches long). At the time of the report, CONTUSION (Bruise on the site of injection which is about 4inches long) had not resolved.            Concomitant medications were reported as allergy medications.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Eye pain, Ocular discomfort, Pyrexia, Reading disorder
Clinical narrative: pressure under both eyes that is sporadic; could not read and had blurred vission; Fever; eye pain with blurred vision; not able to get out of bed/arms weak; eyes hurt/ eye pain with blurred vision; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (not able to get out of bed/arms weak), EYE PAIN (eyes hurt/ eye pain with blurred vision), OCULAR DISCOMFORT (pressure under both eyes that is sporadic), READING DISORDER (could not read and had blurred vission) and VISION BLURRED (eye pain with blurred vision) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No allergies, current medical condition or medical history was reported by the reporter.    On 24-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ASTHENIA (not able to get out of bed/arms weak) and EYE PAIN (eyes hurt/ eye pain with blurred vision). On 24-Mar-2021 at 11:00 AM, the patient experienced VISION BLURRED (eye pain with blurred vision). On 24-Mar-2021 at 5:00 PM, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced OCULAR DISCOMFORT (pressure under both eyes that is sporadic) and READING DISORDER (could not read and had blurred vission). On 25-Mar-2021, PYREXIA (Fever) had not resolved. On 29-Mar-2021, VISION BLURRED (eye pain with blurred vision) had resolved with sequelae. At the time of the report, ASTHENIA (not able to get out of bed/arms weak), EYE PAIN (eyes hurt/ eye pain with blurred vision) and OCULAR DISCOMFORT (pressure under both eyes that is sporadic) had not resolved and READING DISORDER (could not read and had blurred vission) outcome was unknown.            No Concomitant medications were provided by the reporter. No treatment details were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Events added, product information updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: pressure under both eyes that is sporadic; could not read and had blurred vission; Fever; eye pain with blurred vision; not able to get out of bed/arms weak; eyes hurt/ eye pain with blurred vision; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (not able to get out of bed/arms weak), EYE PAIN (eyes hurt/ eye pain with blurred vision), OCULAR DISCOMFORT (pressure under both eyes that is sporadic), READING DISORDER (could not read and had blurred vission) and VISION BLURRED (eye pain with blurred vision) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No allergies, current medical condition or medical history was reported by the reporter.    On 24-Feb-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021 at 8:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced ASTHENIA (not able to get out of bed/arms weak) and EYE PAIN (eyes hurt/ eye pain with blurred vision). On 24-Mar-2021 at 11:00 AM, the patient experienced VISION BLURRED (eye pain with blurred vision). On 24-Mar-2021 at 5:00 PM, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced OCULAR DISCOMFORT (pressure under both eyes that is sporadic) and READING DISORDER (could not read and had blurred vission). On 25-Mar-2021, PYREXIA (Fever) had not resolved. On 29-Mar-2021, VISION BLURRED (eye pain with blurred vision) had resolved with sequelae. At the time of the report, ASTHENIA (not able to get out of bed/arms weak), EYE PAIN (eyes hurt/ eye pain with blurred vision) and OCULAR DISCOMFORT (pressure under both eyes that is sporadic) had not resolved and READING DISORDER (could not read and had blurred vission) outcome was unknown.            No Concomitant medications were provided by the reporter. No treatment details were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Events added, product information updated.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe itching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itching all over the body) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PRURITUS (Severe itching all over the body). At the time of the report, PRURITUS (Severe itching all over the body) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included diphenhydramine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Dry throat, Erythema, Myalgia, Paraesthesia
Clinical narrative: Tingling in hands and feet, face was tingling; Dry throat; Face is tingling and red; I am having some real bad side effects; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in hands and feet, face was tingling), DRY THROAT (Dry throat), ERYTHEMA (Face is tingling and red), ADVERSE REACTION (I am having some real bad side effects) and MYALGIA (Body Aches) in a 38-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 relevant medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (Tingling in hands and feet, face was tingling), DRY THROAT (Dry throat), ERYTHEMA (Face is tingling and red), ADVERSE REACTION (I am having some real bad side effects) and MYALGIA (Body Aches). At the time of the report, PARAESTHESIA (Tingling in hands and feet, face was tingling), DRY THROAT (Dry throat), ERYTHEMA (Face is tingling and red) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.