chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: headache; sweats; fever; chills; PAIN AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills), INJECTION SITE PAIN (PAIN AT INJECTION SITE) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. .    No medical history was provided by the reporter.     On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and INJECTION SITE PAIN (PAIN AT INJECTION SITE). On 29-Jan-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 28-Jan-2021, PYREXIA (fever), CHILLS (chills) and INJECTION SITE PAIN (PAIN AT INJECTION SITE) had resolved. On 29-Jan-2021, HYPERHIDROSIS (sweats) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99f Inconclusive.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; sweats; fever; chills; PAIN AT INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills), INJECTION SITE PAIN (PAIN AT INJECTION SITE) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. .    No medical history was provided by the reporter.     On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and INJECTION SITE PAIN (PAIN AT INJECTION SITE). On 29-Jan-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 28-Jan-2021, PYREXIA (fever), CHILLS (chills) and INJECTION SITE PAIN (PAIN AT INJECTION SITE) had resolved. On 29-Jan-2021, HYPERHIDROSIS (sweats) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99f Inconclusive.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: taste seemed off; morning smell seemed off; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (taste seemed off) and ANOSMIA (morning smell seemed off) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043LZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included VITAMINS;MINERALS;LYSINE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (taste seemed off) and ANOSMIA (morning smell seemed off). At the time of the report, AGEUSIA (taste seemed off) and ANOSMIA (morning smell seemed off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Redness at injection site; Itchiness at injection site; Warm to touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE WARMTH (Warm to touch at injection site) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251202A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) and ATORVASTATIN for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE WARMTH (Warm to touch at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE WARMTH (Warm to touch at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Somnolence
Clinical narrative: Headache; arm pain (felt sore); felt groggy; super tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain (felt sore)), SOMNOLENCE (felt groggy), FATIGUE (super tired) and HEADACHE (Headache) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain (felt sore)), SOMNOLENCE (felt groggy) and FATIGUE (super tired). On 04-Feb-2021, the patient experienced HEADACHE (Headache). On 04-Feb-2021, SOMNOLENCE (felt groggy) and FATIGUE (super tired) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain (felt sore)) and HEADACHE (Headache) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: chills; a fever of 101; arm was swollen; arm was itchy; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (a fever of 101), PERIPHERAL SWELLING (arm was swollen) and PRURITUS (arm was itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (a fever of 101), PERIPHERAL SWELLING (arm was swollen) and PRURITUS (arm was itchy). At the time of the report, CHILLS (chills), PYREXIA (a fever of 101), PERIPHERAL SWELLING (arm was swollen) and PRURITUS (arm was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased
Clinical narrative: High blood pressure; sore arm (left); This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High blood pressure) and ARTHRALGIA (sore arm (left)) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included FISH OIL, CALCIUM, VITAMIN C [ASCORBIC ACID] and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced ARTHRALGIA (sore arm (left)). On 30-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (High blood pressure). On 29-Jan-2021, ARTHRALGIA (sore arm (left)) had resolved. On 30-Jan-2021, BLOOD PRESSURE INCREASED (High blood pressure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Correspondence email attached & In form the event outcome updated; Reporter's Comments: The events were consistent with increased risk of complications associated with hypertension confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.; Sender's Comments: Spoke with the patient and she said that the anti-inflammatory medication that her doctor prescribed raised her blood pressure (BP) and it wasn't due to the shot. Her BP is fine now. The sore arm was really nothing, the reaction was very mild. She feels fine now.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: arm is sore; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore) and INSOMNIA (could not sleep) 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 03-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 PAIN IN EXTREMITY (arm is sore) and INSOMNIA (could not sleep). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm is sore) and INSOMNIA (could not sleep) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Tylenol for drug use for unknown indication.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes on her right armpit and at the base of her neck, like above her collar bone, on the right side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes on her right armpit and at the base of her neck, like above her collar bone, on the right side) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     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 03-Feb-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on her right armpit and at the base of her neck, like above her collar bone, on the right side). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes on her right armpit and at the base of her neck, like above her collar bone, on the right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product us was reported No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: extreme exhaustion; really really tired; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme exhaustion), FATIGUE (really really tired) and VACCINATION SITE PAIN (very sore arm) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (very sore arm). On 02-Feb-2021, the patient experienced FATIGUE (extreme exhaustion) and FATIGUE (really really tired). At the time of the report, FATIGUE (extreme exhaustion), FATIGUE (really really tired) and VACCINATION SITE PAIN (very sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Discomfort, Erythema, Fatigue, Lethargy
Clinical narrative: Very sharp pain in the pelvis area; Very very slight little sensation enough to know that there is something; Left arm very sore; Lethargic,like a zombie; very tired; Red area; itchy; Pain in chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red area), PRURITUS (itchy), CHEST PAIN (Pain in chest), PAIN IN EXTREMITY (Left arm very sore) and LETHARGY (Lethargic,like a zombie) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced CHEST PAIN (Pain in chest). On 01-Jan-2021, the patient experienced ERYTHEMA (Red area) and PRURITUS (itchy). On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left arm very sore), LETHARGY (Lethargic,like a zombie) and FATIGUE (very tired). On 02-Feb-2021, the patient experienced PELVIC PAIN (Very sharp pain in the pelvis area) and DISCOMFORT (Very very slight little sensation enough to know that there is something). On 05-Jan-2021, ERYTHEMA (Red area) and PRURITUS (itchy) had resolved. On 29-Jan-2021, FATIGUE (very tired) had resolved. On 02-Feb-2021, PELVIC PAIN (Very sharp pain in the pelvis area) and DISCOMFORT (Very very slight little sensation enough to know that there is something) had resolved. At the time of the report, CHEST PAIN (Pain in chest), PAIN IN EXTREMITY (Left arm very sore) and LETHARGY (Lethargic,like a zombie) outcome was unknown. Not Provided          No concomitant medication was provided.  Treatment information included CBD oil.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pelvic pain, Pruritus
Clinical narrative: Very sharp pain in the pelvis area; Very very slight little sensation enough to know that there is something; Left arm very sore; Lethargic,like a zombie; very tired; Red area; itchy; Pain in chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red area), PRURITUS (itchy), CHEST PAIN (Pain in chest), PAIN IN EXTREMITY (Left arm very sore) and LETHARGY (Lethargic,like a zombie) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced CHEST PAIN (Pain in chest). On 01-Jan-2021, the patient experienced ERYTHEMA (Red area) and PRURITUS (itchy). On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Left arm very sore), LETHARGY (Lethargic,like a zombie) and FATIGUE (very tired). On 02-Feb-2021, the patient experienced PELVIC PAIN (Very sharp pain in the pelvis area) and DISCOMFORT (Very very slight little sensation enough to know that there is something). On 05-Jan-2021, ERYTHEMA (Red area) and PRURITUS (itchy) had resolved. On 29-Jan-2021, FATIGUE (very tired) had resolved. On 02-Feb-2021, PELVIC PAIN (Very sharp pain in the pelvis area) and DISCOMFORT (Very very slight little sensation enough to know that there is something) had resolved. At the time of the report, CHEST PAIN (Pain in chest), PAIN IN EXTREMITY (Left arm very sore) and LETHARGY (Lethargic,like a zombie) outcome was unknown. Not Provided          No concomitant medication was provided.  Treatment information included CBD oil.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Headache, Nausea, Pyrexia
Clinical narrative: Could hardly walk; Weak; Felt nauseated; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could hardly walk), ASTHENIA (Weak), NAUSEA (Felt nauseated), HEADACHE (Headache) and PYREXIA (Fever) in an 85-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 (No reported medical history).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced GAIT DISTURBANCE (Could hardly walk), ASTHENIA (Weak), NAUSEA (Felt nauseated), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, GAIT DISTURBANCE (Could hardly walk), ASTHENIA (Weak), NAUSEA (Felt nauseated), HEADACHE (Headache) and PYREXIA (Fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever at night; Nausea; Vomiting; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever at night), NAUSEA (Nausea), VOMITING (Vomiting) and ARTHRALGIA (Joint pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever at night), NAUSEA (Nausea), VOMITING (Vomiting) and ARTHRALGIA (Joint pain). At the time of the report, CHILLS (Chills), PYREXIA (Fever at night), NAUSEA (Nausea), VOMITING (Vomiting) and ARTHRALGIA (Joint pain) had resolved. Not Provided          No concomitant medications were reported.  Treatment details were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Cough, Fatigue, Headache
Clinical narrative: arm pain; Lingering Fatigue; Sporadic headache; BACK PAIN; INSOMNIA; cough; Low grade temp; Worn out; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), FATIGUE (Lingering Fatigue), HEADACHE (Sporadic headache), BACK PAIN (BACK PAIN) and INSOMNIA (INSOMNIA) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease, Diverticulitis, Diabetes mellitus (controlled type 2 diabetic.) and Immunosuppression. Concomitant products included USTEKINUMAB (STELARA) for Immunosuppression.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), FATIGUE (Lingering Fatigue), HEADACHE (Sporadic headache), BACK PAIN (BACK PAIN), INSOMNIA (INSOMNIA), COUGH (cough), PYREXIA (Low grade temp) and FATIGUE (Worn out). At the time of the report, PAIN IN EXTREMITY (arm pain), FATIGUE (Lingering Fatigue), HEADACHE (Sporadic headache), BACK PAIN (BACK PAIN), INSOMNIA (INSOMNIA), COUGH (cough), PYREXIA (Low grade temp) and FATIGUE (Worn out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, COVID-19: positive (Positive) Positive Covid -19 Test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Pyrexia
Clinical narrative: arm pain; Lingering Fatigue; Sporadic headache; BACK PAIN; INSOMNIA; cough; Low grade temp; Worn out; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), FATIGUE (Lingering Fatigue), HEADACHE (Sporadic headache), BACK PAIN (BACK PAIN) and INSOMNIA (INSOMNIA) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease, Diverticulitis, Diabetes mellitus (controlled type 2 diabetic.) and Immunosuppression. Concomitant products included USTEKINUMAB (STELARA) for Immunosuppression.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), FATIGUE (Lingering Fatigue), HEADACHE (Sporadic headache), BACK PAIN (BACK PAIN), INSOMNIA (INSOMNIA), COUGH (cough), PYREXIA (Low grade temp) and FATIGUE (Worn out). At the time of the report, PAIN IN EXTREMITY (arm pain), FATIGUE (Lingering Fatigue), HEADACHE (Sporadic headache), BACK PAIN (BACK PAIN), INSOMNIA (INSOMNIA), COUGH (cough), PYREXIA (Low grade temp) and FATIGUE (Worn out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, COVID-19: positive (Positive) Positive Covid -19 Test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 102.5 f fever 12 hrs after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102.5 f fever 12 hrs after 2nd dose) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (102.5 f fever 12 hrs after 2nd dose). At the time of the report, PYREXIA (102.5 f fever 12 hrs after 2nd dose) outcome was unknown.          No concomitant medications were reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Ultrasound testes, Vaccination site pain
Clinical narrative: Pregnancy; pain at the injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (pain at the injection site) in a 30-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (3 ). Concurrent medical conditions included Blood pressure high. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 01-Aug-2017 to an unknown date for Pregnancy, CALCIUM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 08-May-2021. On 24-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (pain at the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: inconclusive (Inconclusive) Inconclusive. On an unknown date, Ultrasound testes: normal (normal) healthy outcome.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information for the event was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: Lab data, pregnancy details, concomitant medication were updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling, Vaccination site mass, Vaccination site warmth
Clinical narrative: Red patch; Itchy; swelled; Bumpy; Very Hot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red patch), PRURITUS (Itchy), SWELLING (swelled), VACCINATION SITE MASS (Bumpy) and VACCINATION SITE WARMTH (Very Hot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced ERYTHEMA (Red patch), PRURITUS (Itchy), SWELLING (swelled), VACCINATION SITE MASS (Bumpy) and VACCINATION SITE WARMTH (Very Hot). At the time of the report, ERYTHEMA (Red patch) had not resolved and PRURITUS (Itchy), SWELLING (swelled), VACCINATION SITE MASS (Bumpy) and VACCINATION SITE WARMTH (Very Hot) 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.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia, Vaccination site reaction
Clinical narrative: fever; chills; FATIGUE; Headache; Covid arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (Covid arm), PYREXIA (fever), CHILLS (chills), FATIGUE (FATIGUE) and HEADACHE (Headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE REACTION (Covid arm). On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (FATIGUE) and HEADACHE (Headache). On 04-Feb-2021, VACCINATION SITE REACTION (Covid arm) had resolved. At the time of the report, PYREXIA (fever), CHILLS (chills), FATIGUE (FATIGUE) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hypoaesthesia, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of paresthesia (tingling of hands, feet and leg), hypoesthesia (numbness of hands, feet and leg), headache, chills and fatigue in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. The patient's past medical history included no adverse event. On Feb 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 19, 2021, patient experienced paresthesia (tingling of hands, feet and leg), hypoesthesia (numbness of hands, feet and leg), headache, chills, fatigue, myalgia (muscle aches) and pain (soreness). At the time of the report, paresthesia (tingling of hands, feet and leg), hypoesthesia (numbness of hands, feet and leg), headache, chills, fatigue, myalgia (muscle aches) and pain (soreness) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of paresthesia (tingling of hands, feet and leg), hypoesthesia (numbness of hands, feet and leg), headache, chills and fatigue in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. The patient's past medical history included no adverse event. On Feb 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 19, 2021, patient experienced paresthesia (tingling of hands, feet and leg), hypoesthesia (numbness of hands, feet and leg), headache, chills, fatigue, myalgia (muscle aches) and pain (soreness). At the time of the report, paresthesia (tingling of hands, feet and leg), hypoesthesia (numbness of hands, feet and leg), headache, chills, fatigue, myalgia (muscle aches) and pain (soreness) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Reporter did not allow further contact.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue) in an 80-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 medical history was reported.).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN (Body aches), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN (Body aches), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: injection site warm to the touch; injection site was hard; injection site was red; soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness), INJECTION SITE WARMTH (injection site warm to the touch), INJECTION SITE ERYTHEMA (injection site was red) and INJECTION SITE INDURATION (injection site was hard) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included CALCIUM, VITAMIN D NOS and SALMON OIL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness). On 29-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site warm to the touch), INJECTION SITE ERYTHEMA (injection site was red) and INJECTION SITE INDURATION (injection site was hard). On 25-Jan-2021, INJECTION SITE PAIN (soreness) had resolved. At the time of the report, INJECTION SITE WARMTH (injection site warm to the touch), INJECTION SITE ERYTHEMA (injection site was red) and INJECTION SITE INDURATION (injection site was hard) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information provided by reporter included cold compress to relieve the symptoms.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Injection site erythema, Rash pruritic
Clinical narrative: rash came back at the injection site and ran to the back of arm and up to her cheek; rash was itchy; also experienced shortness of breath; red hive at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONDITION AGGRAVATED (rash came back at the injection site and ran to the back of arm and up to her cheek), RASH PRURITIC (rash was itchy), DYSPNOEA (also experienced shortness of breath) and INJECTION SITE ERYTHEMA (red hive at the injection site) 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 Breast cancer in 2014, Cancer surgery (Breast Cancer) in 2014 and Radiotherapy (Breast Cancer) in 2014. Concurrent medical conditions included Asthma.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (red hive at the injection site). On 24-Jan-2021, the patient experienced CONDITION AGGRAVATED (rash came back at the injection site and ran to the back of arm and up to her cheek), RASH PRURITIC (rash was itchy) and DYSPNOEA (also experienced shortness of breath). The patient was treated with CORTISONE in January 2021 for Adverse event following immunisation, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) in January 2021 for Adverse event following immunisation, at a dose of 1 dosage form and METHYLPREDNISOLONE on 16-Jan-2021 for Adverse event following immunisation, at a dose of 4 mg. On 22-Jan-2021, INJECTION SITE ERYTHEMA (red hive at the injection site) had resolved. At the time of the report, CONDITION AGGRAVATED (rash came back at the injection site and ran to the back of arm and up to her cheek) and RASH PRURITIC (rash was itchy) was resolving and DYSPNOEA (also experienced shortness of breath) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was provided by the reporter   This case was linked to MOD-2021-021201 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received included no new information.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Malaise
Clinical narrative: malaise; muscle and joint pain; muscle and joint pain; headache; had trouble concentrating; fatigued; mild soreness in my left arm at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), FEELING ABNORMAL (had trouble concentrating), FATIGUE (fatigued), VACCINATION SITE PAIN (mild soreness in my left arm at the site of injection) and MYALGIA (muscle and joint pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021 at 11:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FEELING ABNORMAL (had trouble concentrating), FATIGUE (fatigued) and VACCINATION SITE PAIN (mild soreness in my left arm at the site of injection). On 30-Jan-2021, the patient experienced MALAISE (malaise), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain) and HEADACHE (headache). At the time of the report, MALAISE (malaise), FEELING ABNORMAL (had trouble concentrating), FATIGUE (fatigued), VACCINATION SITE PAIN (mild soreness in my left arm at the site of injection), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: malaise; muscle and joint pain; muscle and joint pain; headache; had trouble concentrating; fatigued; mild soreness in my left arm at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), FEELING ABNORMAL (had trouble concentrating), FATIGUE (fatigued), VACCINATION SITE PAIN (mild soreness in my left arm at the site of injection) and MYALGIA (muscle and joint pain) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021 at 11:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FEELING ABNORMAL (had trouble concentrating), FATIGUE (fatigued) and VACCINATION SITE PAIN (mild soreness in my left arm at the site of injection). On 30-Jan-2021, the patient experienced MALAISE (malaise), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain) and HEADACHE (headache). At the time of the report, MALAISE (malaise), FEELING ABNORMAL (had trouble concentrating), FATIGUE (fatigued), VACCINATION SITE PAIN (mild soreness in my left arm at the site of injection), MYALGIA (muscle and joint pain), ARTHRALGIA (muscle and joint pain) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Incorrect route of product administration, Limb discomfort, Pruritus, Rash macular
Clinical narrative: Feels that nurse gave vaccine in fat instead of muscle; Big spot and it expanding about 4 inches; Red (spot); itchy (spot); Having very heavy arm; A spontaneous report was received from a consumer concerning about a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and after a week she got big red itchy spot and it expanding about 4 inches. she was having very heavy arm and feels that nurse gave vaccine in fat instead of muscle.  The patient's medical history was not reported. Concomitant medications were not reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via an unknown route in the arm for prophylaxis of COVID-19 infection.  On an unknown date, a week after vaccination she got big red itchy spot and it expanding about 4 inches. she was having very heavy arm and feels that nurse gave vaccine in fat instead of muscle. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events are unknown.  The outcomes of the events, she got big red itchy spot and it expanding about 4 inches, she was having very heavy arm was unknown. The outcome of the event, feels that nurse gave vaccine in fat instead of muscle was considered as recovered.; Reporter's Comments: This report refers to a case of Incorrect route of product administration for mRNA-1273, lot # unknown,  with adverse events of rash macular, erythema , pruritus and limb discomfort. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: odd side effect started, which I didn't know was a side effect at the time; then become numb; then up my face, about halfway up my face became numb; the arm at the injection site has 3 big round red lumps; hard to the touch; very sensitive; body aches; diarrhea; you just feel tired; wiped out; headache; fever of 101-102F; normal side effects with the chills and everything; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (odd side effect started, which I didn't know was a side effect at the time), HYPOAESTHESIA ORAL (then become numb), HYPOAESTHESIA (then up my face, about halfway up my face became numb), VACCINATION SITE MASS (the arm at the injection site has 3 big round red lumps) and VACCINATION SITE INDURATION (hard to the touch) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0209L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ADVERSE REACTION (odd side effect started, which I didn't know was a side effect at the time), HYPOAESTHESIA ORAL (then become numb), HYPOAESTHESIA (then up my face, about halfway up my face became numb), VACCINATION SITE MASS (the arm at the injection site has 3 big round red lumps), VACCINATION SITE INDURATION (hard to the touch), SENSITIVE SKIN (very sensitive), MYALGIA (body aches), DIARRHOEA (diarrhea), FATIGUE (you just feel tired), FEELING ABNORMAL (wiped out), HEADACHE (headache), PYREXIA (fever of 101-102F) and CHILLS (normal side effects with the chills and everything). The patient was treated with PARACETAMOL (TYLENOL) on 06-Feb-2021 for Fever, at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (odd side effect started, which I didn't know was a side effect at the time), HYPOAESTHESIA ORAL (then become numb), HYPOAESTHESIA (then up my face, about halfway up my face became numb), VACCINATION SITE MASS (the arm at the injection site has 3 big round red lumps), VACCINATION SITE INDURATION (hard to the touch), SENSITIVE SKIN (very sensitive), MYALGIA (body aches), DIARRHOEA (diarrhea), FATIGUE (you just feel tired), FEELING ABNORMAL (wiped out), HEADACHE (headache), PYREXIA (fever of 101-102F) and CHILLS (normal side effects with the chills and everything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Pyrexia: unknown (High) 101-102 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medications were Tylenol.