chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: He had a temperature of 104.5F on Friday, Saturday, and Sunday; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He had a temperature of 104.5F on Friday, Saturday, and Sunday) and MYALGIA (body aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    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 PYREXIA (He had a temperature of 104.5F on Friday, Saturday, and Sunday) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PYREXIA (He had a temperature of 104.5F on Friday, Saturday, and Sunday) had resolved. On 08-Mar-2021, MYALGIA (body aches) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment  medication: Ibuprofen
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: sick; couldn't eat; couldn't get out of bed; tremendous headache; joint pains; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache) and ARTHRALGIA (joint pains) in an 81-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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache), ARTHRALGIA (joint pains), CHILLS (chills) and NAUSEA (nausea). On 06-Feb-2021, ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache), ARTHRALGIA (joint pains), CHILLS (chills) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient contracted the COVID-19 virus in September 2020, and was hospitalized from 26Sep2020 to 30Sep2020. No Concomitant Medications were  provided by Reporter
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: sick; couldn't eat; couldn't get out of bed; tremendous headache; joint pains; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache) and ARTHRALGIA (joint pains) in an 81-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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache), ARTHRALGIA (joint pains), CHILLS (chills) and NAUSEA (nausea). On 06-Feb-2021, ILLNESS (sick), DECREASED APPETITE (couldn't eat), FATIGUE (couldn't get out of bed), HEADACHE (tremendous headache), ARTHRALGIA (joint pains), CHILLS (chills) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient contracted the COVID-19 virus in September 2020, and was hospitalized from 26Sep2020 to 30Sep2020. No Concomitant Medications were  provided by Reporter
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site hypertrophy, Injection site pruritus, Injection site swelling, Vaccination site pain
Clinical narrative: njection site is red; injection site is itchy; injection site is the size of a golf ball; injection site soreness/injection site tenderness; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site soreness/injection site tenderness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (njection site is red), INJECTION SITE PRURITUS (injection site is itchy) and INJECTION SITE HYPERTROPHY (injection site is the size of a golf ball) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness/injection site tenderness) and INJECTION SITE SWELLING (injection site swelling). On 07-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (njection site is red), INJECTION SITE PRURITUS (injection site is itchy) and INJECTION SITE HYPERTROPHY (injection site is the size of a golf ball). At the time of the report, VACCINATION SITE PAIN (injection site soreness/injection site tenderness), INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ERYTHEMA (njection site is red), INJECTION SITE PRURITUS (injection site is itchy) and INJECTION SITE HYPERTROPHY (injection site is the size of a golf ball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were  provided by Reporter No Treatment Medications were  provided by Reporter   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Influenza like illness
Clinical narrative: headache; shivering; HOT; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (shivering), FEELING HOT (HOT) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), CHILLS (shivering), FEELING HOT (HOT) and INFLUENZA LIKE ILLNESS (flu like symptoms). On 07-Mar-2021, HEADACHE (headache), CHILLS (shivering), FEELING HOT (HOT) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment included Tylenol every 6 hrs.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: TCR attached
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Fatigue, Muscular weakness, Pyrexia
Clinical narrative: Hot then cold; She says she couldn't stand; Really fatigued day after 1st dose; maybe with fever after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE FLUCTUATION (Hot then cold), MUSCULAR WEAKNESS (She says she couldn't stand), FATIGUE (Really fatigued day after 1st dose) and PYREXIA (maybe with fever after 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001a21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Concurrent medical conditions included Hypertension. Concomitant products included METOPROLOL, CLONIDINE, LOSARTAN, MONTELUKAST, SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced BODY TEMPERATURE FLUCTUATION (Hot then cold), MUSCULAR WEAKNESS (She says she couldn't stand), FATIGUE (Really fatigued day after 1st dose) and PYREXIA (maybe with fever after 1st dose). At the time of the report, BODY TEMPERATURE FLUCTUATION (Hot then cold), MUSCULAR WEAKNESS (She says she couldn't stand), FATIGUE (Really fatigued day after 1st dose) and PYREXIA (maybe with fever after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Illness, Myalgia
Clinical narrative: sick; chest pain; tired; body aches all over; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), CHEST PAIN (chest pain), FATIGUE (tired) and MYALGIA (body aches all over) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ILLNESS (sick), CHEST PAIN (chest pain), FATIGUE (tired) and MYALGIA (body aches all over). On 18-Feb-2021, FATIGUE (tired) outcome was unknown. At the time of the report, ILLNESS (sick), CHEST PAIN (chest pain) and MYALGIA (body aches all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were  provided by Reporter. No treatment Medications were  provided by Reporter.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: low energy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (low energy) and FATIGUE (Fatigue). The patient was treated with CYCLOSPORINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ASTHENIA (low energy) and FATIGUE (Fatigue) had resolved.            Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up : Updated patient info and events outcome as resolved.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: they both felt like flu-like symptoms; achy; no appetite; her right arm extremely sore; loss of taste; tired/exhaustion; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), PAIN (achy), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (her right arm extremely sore) and AGEUSIA (loss of taste) in a 79-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.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), PAIN (achy), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (her right arm extremely sore), AGEUSIA (loss of taste), FATIGUE (tired/exhaustion), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVEL) at an unspecified dose and frequency. On 06-Mar-2021, INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), PAIN (achy), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (her right arm extremely sore), AGEUSIA (loss of taste), FATIGUE (tired/exhaustion), CHILLS (chills) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pain in extremity
Clinical narrative: they both felt like flu-like symptoms; achy; no appetite; her right arm extremely sore; loss of taste; tired/exhaustion; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), PAIN (achy), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (her right arm extremely sore) and AGEUSIA (loss of taste) in a 79-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.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), PAIN (achy), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (her right arm extremely sore), AGEUSIA (loss of taste), FATIGUE (tired/exhaustion), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVEL) at an unspecified dose and frequency. On 06-Mar-2021, INFLUENZA LIKE ILLNESS (they both felt like flu-like symptoms), PAIN (achy), DECREASED APPETITE (no appetite), PAIN IN EXTREMITY (her right arm extremely sore), AGEUSIA (loss of taste), FATIGUE (tired/exhaustion), CHILLS (chills) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Oesophageal achalasia, Pain
Clinical narrative: closing in on esophagus; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL ACHALASIA (closing in on esophagus) and PAIN (Soreness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included BENAZEPRIL, AMLODIPINE, AMITRIPTYLINE and CLORAZEPATE DIPOTASSIUM (CLORAZEPATE) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced OESOPHAGEAL ACHALASIA (closing in on esophagus) and PAIN (Soreness). At the time of the report, OESOPHAGEAL ACHALASIA (closing in on esophagus) and PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes Calming Exercises
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose, more than 36 days difference from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose, more than 36 days difference from first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose, more than 36 days difference from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose, more than 36 days difference from first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-Jun-2021 and does not contain any new information. Updated reporter E-mail; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Not provided) with no associated AEs.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Burning sensation, Diarrhoea, Erythema, Fatigue
Clinical narrative: felt very lethargic; started feeling tingling of tongue, face and neck immediately and it is still there; face has burning sensation; fatigue; she had abdominal discomfort; nausea; felt as if she was going to faint right away; diarrhea; patient became red,; Patient started with blurred vision in her left eye 2 days later; her tongue went numb; her heartrate accelerated (115 pulse); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (patient became red,), ABDOMINAL DISCOMFORT (she had abdominal discomfort), VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb) and HEART RATE INCREASED (her heartrate accelerated (115 pulse)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb) and HEART RATE INCREASED (her heartrate accelerated (115 pulse)). On 03-Mar-2021, the patient experienced ERYTHEMA (patient became red,), PRESYNCOPE (felt as if she was going to faint right away), DIARRHOEA (diarrhea) and NAUSEA (nausea). On 04-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (she had abdominal discomfort). On an unknown date, the patient experienced LETHARGY (felt very lethargic), PARAESTHESIA ORAL (started feeling tingling of tongue, face and neck immediately and it is still there), BURNING SENSATION (face has burning sensation) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) (intramuscular) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) (intramuscular) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (patient became red,), ABDOMINAL DISCOMFORT (she had abdominal discomfort), VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb), HEART RATE INCREASED (her heartrate accelerated (115 pulse)), PRESYNCOPE (felt as if she was going to faint right away), DIARRHOEA (diarrhea), LETHARGY (felt very lethargic), PARAESTHESIA ORAL (started feeling tingling of tongue, face and neck immediately and it is still there), BURNING SENSATION (face has burning sensation), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up. Adverse event contact information was updated
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia oral, Lethargy, Nausea, Paraesthesia oral
Clinical narrative: felt very lethargic; started feeling tingling of tongue, face and neck immediately and it is still there; face has burning sensation; fatigue; she had abdominal discomfort; nausea; felt as if she was going to faint right away; diarrhea; patient became red,; Patient started with blurred vision in her left eye 2 days later; her tongue went numb; her heartrate accelerated (115 pulse); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (patient became red,), ABDOMINAL DISCOMFORT (she had abdominal discomfort), VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb) and HEART RATE INCREASED (her heartrate accelerated (115 pulse)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb) and HEART RATE INCREASED (her heartrate accelerated (115 pulse)). On 03-Mar-2021, the patient experienced ERYTHEMA (patient became red,), PRESYNCOPE (felt as if she was going to faint right away), DIARRHOEA (diarrhea) and NAUSEA (nausea). On 04-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (she had abdominal discomfort). On an unknown date, the patient experienced LETHARGY (felt very lethargic), PARAESTHESIA ORAL (started feeling tingling of tongue, face and neck immediately and it is still there), BURNING SENSATION (face has burning sensation) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) (intramuscular) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) (intramuscular) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (patient became red,), ABDOMINAL DISCOMFORT (she had abdominal discomfort), VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb), HEART RATE INCREASED (her heartrate accelerated (115 pulse)), PRESYNCOPE (felt as if she was going to faint right away), DIARRHOEA (diarrhea), LETHARGY (felt very lethargic), PARAESTHESIA ORAL (started feeling tingling of tongue, face and neck immediately and it is still there), BURNING SENSATION (face has burning sensation), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up. Adverse event contact information was updated
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Vision blurred
Clinical narrative: felt very lethargic; started feeling tingling of tongue, face and neck immediately and it is still there; face has burning sensation; fatigue; she had abdominal discomfort; nausea; felt as if she was going to faint right away; diarrhea; patient became red,; Patient started with blurred vision in her left eye 2 days later; her tongue went numb; her heartrate accelerated (115 pulse); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (patient became red,), ABDOMINAL DISCOMFORT (she had abdominal discomfort), VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb) and HEART RATE INCREASED (her heartrate accelerated (115 pulse)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb) and HEART RATE INCREASED (her heartrate accelerated (115 pulse)). On 03-Mar-2021, the patient experienced ERYTHEMA (patient became red,), PRESYNCOPE (felt as if she was going to faint right away), DIARRHOEA (diarrhea) and NAUSEA (nausea). On 04-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (she had abdominal discomfort). On an unknown date, the patient experienced LETHARGY (felt very lethargic), PARAESTHESIA ORAL (started feeling tingling of tongue, face and neck immediately and it is still there), BURNING SENSATION (face has burning sensation) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) (intramuscular) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) (intramuscular) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (patient became red,), ABDOMINAL DISCOMFORT (she had abdominal discomfort), VISION BLURRED (Patient started with blurred vision in her left eye 2 days later), HYPOAESTHESIA ORAL (her tongue went numb), HEART RATE INCREASED (her heartrate accelerated (115 pulse)), PRESYNCOPE (felt as if she was going to faint right away), DIARRHOEA (diarrhea), LETHARGY (felt very lethargic), PARAESTHESIA ORAL (started feeling tingling of tongue, face and neck immediately and it is still there), BURNING SENSATION (face has burning sensation), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up. Adverse event contact information was updated
Sex: F
Vaccine: COVID19
Symptoms: Induration, Macule, Product administered at inappropriate site, Swelling
Clinical narrative: Pink-Red Dots; Swelling; Moderna Vaccine Administered in Thigh; Hardness; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (Hardness), MACULE (Pink-Red Dots), SWELLING (Swelling) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in Thigh) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INDURATION (Hardness) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in Thigh). On 06-Mar-2021, the patient experienced MACULE (Pink-Red Dots) and SWELLING (Swelling). On 15-Feb-2021, INDURATION (Hardness) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in Thigh) had resolved. At the time of the report, MACULE (Pink-Red Dots) and SWELLING (Swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment included "Cortizone-10" - Self medicating to try to alleviate symptoms "Cold Compress" - Self medicating to try to alleviate the symptoms
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Burning sensation, Feeling abnormal, Gastrooesophageal reflux disease, Heart rate increased
Clinical narrative: Acid reflux; Burning in feet extending upwards; Burning in chest; Burning in lips and tongue; Elevated Blood pressure; Elevated pulse; Feeling Aweful; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure) and HEART RATE INCREASED (Elevated pulse) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure), HEART RATE INCREASED (Elevated pulse) and FEELING ABNORMAL (Feeling Aweful). On 09-Jan-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, MAGNESIUM HYDROXIDE, SIMETICONE (ANTACID [ALUMINIUM HYDROXIDE GEL;MAGNESIUM HYDROXIDE;SIMETICONE]) at an unspecified dose and frequency. On 11-Jan-2021, BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure) and HEART RATE INCREASED (Elevated pulse) had resolved. At the time of the report, FEELING ABNORMAL (Feeling Aweful) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) 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.   Concomitant products include Beta blockers for blood pressure
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: Acid reflux; Burning in feet extending upwards; Burning in chest; Burning in lips and tongue; Elevated Blood pressure; Elevated pulse; Feeling Aweful; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure) and HEART RATE INCREASED (Elevated pulse) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure), HEART RATE INCREASED (Elevated pulse) and FEELING ABNORMAL (Feeling Aweful). On 09-Jan-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ALUMINIUM HYDROXIDE GEL, MAGNESIUM HYDROXIDE, SIMETICONE (ANTACID [ALUMINIUM HYDROXIDE GEL;MAGNESIUM HYDROXIDE;SIMETICONE]) at an unspecified dose and frequency. On 11-Jan-2021, BURNING SENSATION (Burning in feet extending upwards), BURNING SENSATION (Burning in chest), TONGUE DISCOMFORT (Burning in lips and tongue), BLOOD PRESSURE INCREASED (Elevated Blood pressure) and HEART RATE INCREASED (Elevated pulse) had resolved. At the time of the report, FEELING ABNORMAL (Feeling Aweful) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) 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.   Concomitant products include Beta blockers for blood pressure
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pruritus, Rash, Swelling
Clinical narrative: itchy; soreness; swelling; rash all over; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), RASH (rash all over), PRURITUS (itchy) and ARTHRALGIA (soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced SWELLING (swelling), RASH (rash all over) and ARTHRALGIA (soreness). On 05-Mar-2021, the patient experienced PRURITUS (itchy). On 25-Feb-2021, SWELLING (swelling), RASH (rash all over) and ARTHRALGIA (soreness) had resolved. At the time of the report, PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information include Hydrocortisone cream.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Fatigue, Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule; shingles; Pain in the chest area; Itching; Pain back; Fatigue useless; Pain arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), CHEST PAIN (Pain in the chest area), FATIGUE (Fatigue useless), PRURITUS (Itching) and VACCINATION SITE PAIN (Pain arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (Rash). On 12-Feb-2021, the patient experienced FATIGUE (Fatigue useless), PRURITUS (Itching), VACCINATION SITE PAIN (Pain arm) and BACK PAIN (Pain back). On 26-Feb-2021, the patient experienced HERPES ZOSTER (shingles) and CHEST PAIN (Pain in the chest area). On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule ). On 13-Feb-2021, FATIGUE (Fatigue useless), PRURITUS (Itching), VACCINATION SITE PAIN (Pain arm) and BACK PAIN (Pain back) had resolved. At the time of the report, HERPES ZOSTER (shingles), CHEST PAIN (Pain in the chest area), RASH (Rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule ) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information include Lyrica, Steroid pack,Valtrex
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site pain
Clinical narrative: inappropriate schedule; shingles; Pain in the chest area; Itching; Pain back; Fatigue useless; Pain arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), CHEST PAIN (Pain in the chest area), FATIGUE (Fatigue useless), PRURITUS (Itching) and VACCINATION SITE PAIN (Pain arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (Rash). On 12-Feb-2021, the patient experienced FATIGUE (Fatigue useless), PRURITUS (Itching), VACCINATION SITE PAIN (Pain arm) and BACK PAIN (Pain back). On 26-Feb-2021, the patient experienced HERPES ZOSTER (shingles) and CHEST PAIN (Pain in the chest area). On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule ). On 13-Feb-2021, FATIGUE (Fatigue useless), PRURITUS (Itching), VACCINATION SITE PAIN (Pain arm) and BACK PAIN (Pain back) had resolved. At the time of the report, HERPES ZOSTER (shingles), CHEST PAIN (Pain in the chest area), RASH (Rash) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule ) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information include Lyrica, Steroid pack,Valtrex
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site bruising, Vaccination site discolouration
Clinical narrative: Injection site turned green; Injection site turned black/Injection site turned blue purple; sore all day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore all day), VACCINATION SITE BRUISING (Injection site turned black/Injection site turned blue purple) and VACCINATION SITE DISCOLOURATION (Injection site turned green) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 038K20A) for COVID-19 vaccination.     Concomitant products included LOVASTATIN, LEVOTHYROXINE and ALENDRONATE SODIUM (FOSAMAX) 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 03-Mar-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 PAIN IN EXTREMITY (sore all day). On 04-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Injection site turned black/Injection site turned blue purple). On 08-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Injection site turned green). At the time of the report, PAIN IN EXTREMITY (sore all day), VACCINATION SITE BRUISING (Injection site turned black/Injection site turned blue purple) and VACCINATION SITE DISCOLOURATION (Injection site turned green) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Heart rate irregular
Clinical narrative: irregular heartbeats; joints hurting real bad; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joints hurting real bad) and HEART RATE IRREGULAR (irregular heartbeats) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder (a 20 year history of irregular heartbeats), Open heart surgery (7 to 8 years ago) and Cardiac ablation (7 to 8 years ago).   On 06-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) (unknown route) 1. On 07-Mar-2021, the patient experienced ARTHRALGIA (joints hurting real bad) and HEART RATE IRREGULAR (irregular heartbeats). The patient was treated with PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPRIN) for Joint pain, at an unspecified dose and frequency. On 08-Mar-2021, ARTHRALGIA (joints hurting real bad) and HEART RATE IRREGULAR (irregular heartbeats) had resolved.            No Concomitant Medications were  provided by Reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal eruption
Clinical narrative: rash in her mouth and throat; This spontaneous case was reported by a physician and describes the occurrence of ORAL MUCOSAL ERUPTION (rash in her mouth and throat) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 ORAL MUCOSAL ERUPTION (rash in her mouth and throat). At the time of the report, ORAL MUCOSAL ERUPTION (rash in her mouth and throat) 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 relevant concomitant medications were reported.  No treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (severe headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced HEADACHE (severe headache). At the time of the report, HEADACHE (severe headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were  provided by Reporter. No Treatment Medications were  provided by Reporter.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: "Moderna Arm"; Arm was incredibly hot; Arm red; Arm swollen; Barely sleep for 10 days; COVID ARM; Itchy; Uncomfortable rash on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen) and INSOMNIA (Barely sleep for 10 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.  Concurrent medical conditions included Rosacea. Concomitant products included SPIRONOLACTONE from 01-Jan-2018 to an unknown date for Rosacea.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), INSOMNIA (Barely sleep for 10 days), VACCINATION SITE REACTION (COVID ARM), PRURITUS (Itchy) and RASH (Uncomfortable rash on my arm). On 12-Mar-2021, INSOMNIA (Barely sleep for 10 days) had resolved. On 14-Mar-2021, PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), VACCINATION SITE REACTION (COVID ARM), PRURITUS (Itchy) and RASH (Uncomfortable rash on my arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD-2021-125639 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: ADR form attached on 10-may-2021, new events were added, updated outcome
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site reaction
Clinical narrative: "Moderna Arm"; Arm was incredibly hot; Arm red; Arm swollen; Barely sleep for 10 days; COVID ARM; Itchy; Uncomfortable rash on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen) and INSOMNIA (Barely sleep for 10 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was provided.  Concurrent medical conditions included Rosacea. Concomitant products included SPIRONOLACTONE from 01-Jan-2018 to an unknown date for Rosacea.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), INSOMNIA (Barely sleep for 10 days), VACCINATION SITE REACTION (COVID ARM), PRURITUS (Itchy) and RASH (Uncomfortable rash on my arm). On 12-Mar-2021, INSOMNIA (Barely sleep for 10 days) had resolved. On 14-Mar-2021, PAIN IN EXTREMITY ("Moderna Arm"), FEELING HOT (Arm was incredibly hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen), VACCINATION SITE REACTION (COVID ARM), PRURITUS (Itchy) and RASH (Uncomfortable rash on my arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to MOD-2021-125639 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: ADR form attached on 10-may-2021, new events were added, updated outcome
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Thinking abnormal
Clinical narrative: Brain Fog; dizziness; unsteadiness; inability to think; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain Fog), DIZZINESS (dizziness), BALANCE DISORDER (unsteadiness) and THINKING ABNORMAL (inability to think) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced FEELING ABNORMAL (Brain Fog), DIZZINESS (dizziness), BALANCE DISORDER (unsteadiness) and THINKING ABNORMAL (inability to think). The patient was treated with DIHYDROERGOCRISTINE, LOMIFYLLINE (ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Brain Fog), DIZZINESS (dizziness), BALANCE DISORDER (unsteadiness) and THINKING ABNORMAL (inability to think) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Significant: Patient is feeling better nowfrom events