chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Whole body developed hives; Burning behind the backs of her knees and arms; Head and chest became itchy; Throat was tight; Throat swelled up; Triggered their eczema; This spontaneous case was reported by a health care professional and describes the occurrence of PHARYNGEAL SWELLING (Throat swelled up), ECZEMA (Triggered their eczema), URTICARIA (Whole body developed hives), BURNING SENSATION (Burning behind the backs of her knees and arms) and PRURITUS (Head and chest became itchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 PHARYNGEAL SWELLING (Throat swelled up) and ECZEMA (Triggered their eczema). On an unknown date, the patient experienced URTICARIA (Whole body developed hives), BURNING SENSATION (Burning behind the backs of her knees and arms), PRURITUS (Head and chest became itchy) and THROAT TIGHTNESS (Throat was tight). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at a dose of UNK dosage form. At the time of the report, PHARYNGEAL SWELLING (Throat swelled up), ECZEMA (Triggered their eczema), URTICARIA (Whole body developed hives), BURNING SENSATION (Burning behind the backs of her knees and arms), PRURITUS (Head and chest became itchy) and THROAT TIGHTNESS (Throat was tight) outcome was unknown. Possible      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. Treatment included cream.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Body aches; Arn pain; swelling around neck; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Arn pain), SWELLING (swelling around neck) and PYREXIA (fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Arn pain), SWELLING (swelling around neck) and PYREXIA (fever). At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Arn pain), SWELLING (swelling around neck) and PYREXIA (fever) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: SOB, ended up sitting up; Little cloudiness in the head; Felt like weight in lungs; Little bit of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (SOB, ended up sitting up), FEELING ABNORMAL (Little cloudiness in the head), CHEST DISCOMFORT (Felt like weight in lungs) and FATIGUE (Little bit of fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma chronic. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D), LORATADINE, LEVOTHYROXINE, OMEPRAZOLE, FOLIC ACID and FENOFIBRATE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced DYSPNOEA (SOB, ended up sitting up), FEELING ABNORMAL (Little cloudiness in the head), CHEST DISCOMFORT (Felt like weight in lungs) and FATIGUE (Little bit of fatigue). On 11-Feb-2021, DYSPNOEA (SOB, ended up sitting up), FEELING ABNORMAL (Little cloudiness in the head), CHEST DISCOMFORT (Felt like weight in lungs) and FATIGUE (Little bit of fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: red circle of 3.5-4 in. big; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red circle of 3.5-4 in. big) and INJECTION SITE PRURITUS (Itchy at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Blood pressure medicine for Blood pressure.    On 01-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 INJECTION SITE ERYTHEMA (red circle of 3.5-4 in. big) and INJECTION SITE PRURITUS (Itchy at injection site). At the time of the report, INJECTION SITE ERYTHEMA (red circle of 3.5-4 in. big) and INJECTION SITE PRURITUS (Itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Patient used cold pack Patient mentioned it was not as red as before may be its going away
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm; swollen and red arm; Red blotches, red arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (swollen and red arm) and ERYTHEMA (Red blotches, red arm) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (swollen and red arm) and ERYTHEMA (Red blotches, red arm). At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (swollen and red arm) and ERYTHEMA (Red blotches, red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Had gout days after receiving the vaccine; A spontaneous report was received from a consumer, concerning a male patient who received Moderna's covid-19 vaccine (mRNA-1273) and had gout days after receiving the vaccine.  The patient's medical history and concomitant medication was not provided.  On 11 Feb 2021, prior to the onset of event, the patient received first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of covid-19 infection.  On 14 Feb 2021, the patient developed gout days after receiving the vaccine.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event had gout days after receiving the vaccine was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested as patient's medical history, clinical presentation and diagnostic results are lacking.; Sender's Comments: 24 Feb 2021: The start date of event was captured as 14 Feb 2021, as per narrative (kindly reassess)
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Neck pain, Pain in extremity, Pre-existing condition improved
Clinical narrative: pain has migrated up in her neck; arm is improving; arm was really hurting; couldn't raise left arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain has migrated up in her neck), PRE-EXISTING CONDITION IMPROVED (arm is improving), PAIN IN EXTREMITY (arm was really hurting) and LIMB DISCOMFORT (couldn't raise left arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, High cholesterol, Tetanus and Penicillin allergy. Concomitant products included PRAVASTATIN, LOSARTAN, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), BIOTIN and FISH OIL for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was really hurting) and LIMB DISCOMFORT (couldn't raise left arm). On an unknown date, the patient experienced NECK PAIN (pain has migrated up in her neck) and PRE-EXISTING CONDITION IMPROVED (arm is improving). At the time of the report, NECK PAIN (pain has migrated up in her neck), PRE-EXISTING CONDITION IMPROVED (arm is improving), PAIN IN EXTREMITY (arm was really hurting) and LIMB DISCOMFORT (couldn't raise left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Limb discomfort, Myalgia, Pain in extremity
Clinical narrative: Delayed injection site reaction; Injection site warm to touch; Arm feeeling heavy; Arm pain; Injection site itching; Injection site induration; Injection site swollen; Injection site redness; Low grade temperature; Body aches; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Delayed injection site reaction), VACCINATION SITE WARMTH (Injection site warm to touch), LIMB DISCOMFORT (Arm feeeling heavy), PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE PRURITUS (Injection site itching) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION COMPLICATION (Delayed injection site reaction), VACCINATION SITE WARMTH (Injection site warm to touch), LIMB DISCOMFORT (Arm feeeling heavy), PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE ERYTHEMA (Injection site redness), PYREXIA (Low grade temperature), MYALGIA (Body aches) and FATIGUE (Fatigue). At the time of the report, VACCINATION COMPLICATION (Delayed injection site reaction), VACCINATION SITE WARMTH (Injection site warm to touch), LIMB DISCOMFORT (Arm feeeling heavy), PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE ERYTHEMA (Injection site redness), PYREXIA (Low grade temperature), MYALGIA (Body aches) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Body temperature: 99.7 Temp:99.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Delayed injection site reaction; Injection site warm to touch; Arm feeeling heavy; Arm pain; Injection site itching; Injection site induration; Injection site swollen; Injection site redness; Low grade temperature; Body aches; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Delayed injection site reaction), VACCINATION SITE WARMTH (Injection site warm to touch), LIMB DISCOMFORT (Arm feeeling heavy), PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE PRURITUS (Injection site itching) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION COMPLICATION (Delayed injection site reaction), VACCINATION SITE WARMTH (Injection site warm to touch), LIMB DISCOMFORT (Arm feeeling heavy), PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE ERYTHEMA (Injection site redness), PYREXIA (Low grade temperature), MYALGIA (Body aches) and FATIGUE (Fatigue). At the time of the report, VACCINATION COMPLICATION (Delayed injection site reaction), VACCINATION SITE WARMTH (Injection site warm to touch), LIMB DISCOMFORT (Arm feeeling heavy), PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE ERYTHEMA (Injection site redness), PYREXIA (Low grade temperature), MYALGIA (Body aches) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Body temperature: 99.7 Temp:99.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Delayed injection site reaction; Injection site warm to touch; Arm feeeling heavy; Arm pain; Injection site itching; Injection site induration; Injection site swollen; Injection site redness; Low grade temperature; Body aches; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Delayed injection site reaction), VACCINATION SITE WARMTH (Injection site warm to touch), LIMB DISCOMFORT (Arm feeeling heavy), PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE PRURITUS (Injection site itching) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION COMPLICATION (Delayed injection site reaction), VACCINATION SITE WARMTH (Injection site warm to touch), LIMB DISCOMFORT (Arm feeeling heavy), PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE ERYTHEMA (Injection site redness), PYREXIA (Low grade temperature), MYALGIA (Body aches) and FATIGUE (Fatigue). At the time of the report, VACCINATION COMPLICATION (Delayed injection site reaction), VACCINATION SITE WARMTH (Injection site warm to touch), LIMB DISCOMFORT (Arm feeeling heavy), PAIN IN EXTREMITY (Arm pain), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE SWELLING (Injection site swollen), VACCINATION SITE ERYTHEMA (Injection site redness), PYREXIA (Low grade temperature), MYALGIA (Body aches) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Body temperature: 99.7 Temp:99.7.     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.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blepharospasm, Peripheral swelling
Clinical narrative: Back started hurting; eye twitching in her right eye; swollen hand.; This spontaneous case was reported by a consumer and describes the occurrence of BLEPHAROSPASM (eye twitching in her right eye), PERIPHERAL SWELLING (swollen hand.) and BACK PAIN (Back started hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot 007M20A) for COVID-19 immunisation.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 13-Feb-2021, the patient experienced BLEPHAROSPASM (eye twitching in her right eye) and PERIPHERAL SWELLING (swollen hand.). On 14-Feb-2021, the patient experienced BACK PAIN (Back started hurting). On 16-Feb-2021, BLEPHAROSPASM (eye twitching in her right eye) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen hand.) and BACK PAIN (Back started hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included POTASSIUM for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema, Fatigue, Headache, Pain
Clinical narrative: bodyaches; tired; fever; cough; HEACHACHES; SWELLING; REDNESS; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (SWELLING), ERYTHEMA (REDNESS), PYREXIA (fever), COUGH (cough) and HEADACHE (HEACHACHES) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) and GUAIFENESIN (MUCINEX) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SWELLING (SWELLING) and ERYTHEMA (REDNESS). On 15-Feb-2021, the patient experienced PYREXIA (fever), COUGH (cough) and HEADACHE (HEACHACHES). On an unknown date, the patient experienced PAIN (bodyaches) and FATIGUE (tired). At the time of the report, SWELLING (SWELLING), ERYTHEMA (REDNESS), PYREXIA (fever), COUGH (cough), HEADACHE (HEACHACHES), PAIN (bodyaches) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: bodyaches; tired; fever; cough; HEACHACHES; SWELLING; REDNESS; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (SWELLING), ERYTHEMA (REDNESS), PYREXIA (fever), COUGH (cough) and HEADACHE (HEACHACHES) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) and GUAIFENESIN (MUCINEX) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SWELLING (SWELLING) and ERYTHEMA (REDNESS). On 15-Feb-2021, the patient experienced PYREXIA (fever), COUGH (cough) and HEADACHE (HEACHACHES). On an unknown date, the patient experienced PAIN (bodyaches) and FATIGUE (tired). At the time of the report, SWELLING (SWELLING), ERYTHEMA (REDNESS), PYREXIA (fever), COUGH (cough), HEADACHE (HEACHACHES), PAIN (bodyaches) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (Hives) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; my arm felt like someone punched me; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PAIN (my arm felt like someone punched me) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and NICOTINIC ACID, SIMVASTATIN (SIMCOR [NICOTINIC ACID;SIMVASTATIN]) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (my arm felt like someone punched me). On 14-Feb-2021, the patient experienced HEADACHE (headache). On 15-Feb-2021, PAIN (my arm felt like someone punched me) outcome was unknown. At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Worried and anxious after receiving 1st dose; A Spontaneous report was received from consumer of unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and was worried and anxious after receiving first dose.  The patient's medical history and concomitant medication were not reported.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   On an unknown date, after administration of first dose of vaccine, the patient was worried and anxious. Treatment information was not provided.  Action taken with the mRNA-1273 in response to the event was not provided.   The outcome of event worried and anxious after receiving first dose was considered unknown at the time of this report.; Reporter's Comments: This case concerns a patient, who experienced a non-serious unexpected event of Anxiety, after receiving mRNA- 1273 (Lot# unknown). Very limited information regarding this event has been provided at this time.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site discolouration
Clinical narrative: Soreness of arm; Black blue color at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) and VACCINATION SITE DISCOLOURATION (Black blue color at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and VACCINATION SITE DISCOLOURATION (Black blue color at injection site). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) and VACCINATION SITE DISCOLOURATION (Black blue color at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing when I take full breath; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing when I take full breath) 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 (No adverse event history).    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, the patient experienced COUGH (Coughing when I take full breath). At the time of the report, COUGH (Coughing when I take full breath) outcome was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fatigue, Pain in extremity
Clinical narrative: arm was very sore; tired; her arthritis in hand was painful; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (her arthritis in hand was painful) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Cortisone until November 2020. Past adverse reactions to the above products included No adverse event with Cortisone. Concurrent medical conditions included Arthritis (Hands).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced ARTHRITIS (her arthritis in hand was painful). At the time of the report, ARTHRITIS (her arthritis in hand was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Vaccination site pain
Clinical narrative: sore arm; pulled muscle; A Spontaneous report was received from consumer concerning a female patient of 68 age who received Moderna COVID-19 vaccine (m-RNA-1273) and experienced Pain in extremity, Muscle strain.  The patient has no medical history and no relevant concomitant medications.   On 16-Feb-2021, prior to the onset of the events the patient received their first of dose of two planned doses of mRNA-1273 (lot/batch: 006M20A) Intramuscularly for prophylaxis of COVID-19 infection.  Treatment information was not provided.   The events Vaccination site rash, Pain in extremity, Muscle strain were unknown. The outcome of the events is unknown.   Action taken with mRNA-1273 in response to the events was not reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-015353:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Can't lift the arm,  Huge pain; A spontaneous report was received from a (Consumer) concerning a  55 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (Can't lift the arm and Huge pain) list.      The patient's medical history was not provided. Concomitant medications include Vit D, Mg2+ and K.      On 10-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in the Left Arm for prophylaxis of COVID-19 infection.    On 10-FEB-2021, The patient experienced the events list (Can't lift the arm and Huge pain).     Laboratory details was not provided.    Treatment details include 1200mg ibuprofen.     Action taken with mRNA-1273 in response to the events was not reported.     At the time of this report, the outcome of the event(s)(Can't lift the arm and Huge pain was unknown.    The reporter assessed the event(s), [Can't lift the arm and Huge pain], as related to study drug.  Based on comment, (Can't lift the arm and Huge pain) was changed to vaccination site pain, listed.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Infection from source unknown - ears or sinuses; A spontaneous report was received from a consumer concerning a 72-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced infection from source unknown-ears or sinuses/infection.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.  On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, patient experienced infection from source unknown-ears or sinuses.   Lab details were not provided by the reporter.  Treatment information was not provided. Patient's doctor wanted him to take a mix of steroids and saline.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, infection from source unknown - ears or sinuses was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Injection site pruritus; Injection site redness; A Spontaneous Report was received from consumer concerning herself of age 76 years, who received Moderna's COVID-19 vaccine and experienced Injection site itching and Injection site red ness. The patient's medical history was not provided. Concomitant product use was not provided. On 14 Feb 2021 prior to the onset of the events the patient received their first of two planned doses of mRNA-1273(Unknown batch number) via Intramuscular route for prophylaxis of COVID-19 infection. On 14 Feb 2021  the patient had events Injection site itching and Injection site redness  Treatment information was not provided. Action taken with the mRNA-1273 in response to events is unknown. Outcome of the events Injection site itching and Injection site redness were unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurt; A spontaneous report was received from a consumer concerning a 52-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurt.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) arm hurt.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 13 Feb 2021 the outcome of event(s), arm hurt was resolved.  Based on comment arm hurt was changed to vaccination site pain and listed in all RSI
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Off label use, Oral herpes, Pruritus, Rash
Clinical narrative: Fever blister; Doesn't feel 100%/I wasn't feeling well; kind of itchy; Broke out in a rash/rash in stomach/ rash in both legs/ rash in both arms; received dose 4 months ago and never received second dose/ more than 35 days for second dose/Received the first dose in January and has not gotten the second dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received dose 4 months ago and never received second dose/ more than 35 days for second dose/Received the first dose in January and has not gotten the second dose), ORAL HERPES (Fever blister), MALAISE (Doesn't feel 100%/I wasn't feeling well), PRURITUS (kind of itchy) and RASH (Broke out in a rash/rash in stomach/ rash in both legs/ rash in both arms) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced OFF LABEL USE (received dose 4 months ago and never received second dose/ more than 35 days for second dose/Received the first dose in January and has not gotten the second dose). On an unknown date, the patient experienced ORAL HERPES (Fever blister), MALAISE (Doesn't feel 100%/I wasn't feeling well), PRURITUS (kind of itchy) and RASH (Broke out in a rash/rash in stomach/ rash in both legs/ rash in both arms). The patient was treated with CORTISONE for Itchy rash, at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] for Adverse event following immunisation, at a dose of 1 dosage form. At the time of the report, OFF LABEL USE (received dose 4 months ago and never received second dose/ more than 35 days for second dose/Received the first dose in January and has not gotten the second dose), ORAL HERPES (Fever blister), MALAISE (Doesn't feel 100%/I wasn't feeling well), PRURITUS (kind of itchy) and RASH (Broke out in a rash/rash in stomach/ rash in both legs/ rash in both arms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was interrupted on an unknown date.       Patient called on 16Feb2021 stating she got her 1stdose on 14Jan2021 and was scheduled for 2nd dose 11Feb2021 which is now rescheduled to later date due to fever blister she got after 1st dose and her HCP recommended to postpone.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Significant follow-up received, events added and treatment medications added On 02-Jul-2021: Significant follow up received , event was added On 02-Jul-2021: Non significant follow up; Sender's Comments: This report refers to a case of Off label use for mRNA-1273, lot # 012L20A. Regarding other events, a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the events.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pruritus
Clinical narrative: developed a light pink spot around injection site that was about 5 inches; itchy spot; A Spontaneous report was received from consumer concerning a female patient of 66 age who received Moderna COVID-19 vaccine (m-RNA-1273) and experienced Injection site erythema, Vaccination site pruritus.  The patient has no medical history and no relevant concomitant medications.   On 04-Feb-2021, prior to the onset of the events the patient received their first of dose of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly for prophylaxis of COVID-19 infection.  Treatment for the event included Diphenhydramine hydrochloride.   The events Injection site erythema, Vaccination site pruritus were unknown. The outcome of the events is unknown.   Action taken with mRNA-1273 in response to the events was not reported.  Based on comment, Injection site erythema, Vaccination site pruritus were listed.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Paraesthesia, Tremor, Vaccination site pain
Clinical narrative: tingling in my hands; arm has been extremely sore and painful; couldn't brush my hair; couldn't stretch my arm straight out, it started shaking; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my hands), PAIN IN EXTREMITY (arm has been extremely sore and painful), HYPOKINESIA (couldn't brush my hair) and TREMOR (couldn't stretch my arm straight out, it started shaking) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE and ATENOLOL for an unknown indication. Treatment details include Tylenol to help with the pain.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PARAESTHESIA (tingling in my hands), PAIN IN EXTREMITY (arm has been extremely sore and painful), HYPOKINESIA (couldn't brush my hair) and TREMOR (couldn't stretch my arm straight out, it started shaking). At the time of the report, PARAESTHESIA (tingling in my hands), PAIN IN EXTREMITY (arm has been extremely sore and painful), HYPOKINESIA (couldn't brush my hair) and TREMOR (couldn't stretch my arm straight out, it started shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Based on MSA comment, Pain in extremity changed to Vaccination site pain and listed in all RSI
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Incredible chills; body aches; A spontaneous report was received from a patient concerning a 72-year-old, female patient,who received Moderna's COVID-19 vaccine (mRNA-1273) experienced body aches, chills.    The patient's medical history, was not provided by the reporter. Concomitant medications reported included levothyoroxine sodium    On 10-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 010M20A) I(route of administration npt provided), (injection site unknown) for prophylaxis of COVID-19 infection.       On 10-FEB-2021, prior to receiving mRNA-1273, the patient had some intense body aches for about 36 hours i.e., upto on 12-FEB-2021.On 22-FEB-2021 at morning 2.00 AM he  woke up with incredible chills and body aches and on 28-FEB-2021 he got more side effects. Treatment for the events included Acetamanipohen. lab report results  were not provided.    Action taken with mRNA-1273 in response to the events was not applicable.    The out come of events Body aches, chills were not recovered or resolved
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Vaccination site pain
Clinical narrative: Pain at the injection site; Nose bleeding; A spontaneous report was received from a (Consumer) concerning an unknown age, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pain at the injection site and Nose bleeding.  The patient's medical history was not included. No relevant concomitant medications were reported.    On 13 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route and site for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced Pain at the injection site and nose bleeding. Laboratory details not provided. Treatment details not included. Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: Phantosmia; A spontaneous report was received from a consumer concerning a 65 year old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and smelled really strong like blood.  The patient's medical history was not provided by the reporter.  The relevant concomitant medications use was not provided.   On 08 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch numbe: unknown) through unknown route for prophylaxis of COVID-19 infection.   On unspecified date the patient was smelling really strong like blood.  Laboratory details were not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event smelling really strong like blood was unknown.; Reporter'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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash, Vaccination site erythema
Clinical narrative: Allergic type reaction; Rash; Big red block on the arm; A spontaneous report was received from a physician concerning a 78-year-old, female patient who experienced a big red block on the arm/erythema, allergic type reaction/hypersensitivity, and rash.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On an unspecified date, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.   On 10 Feb 2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis.  On an unspecified date, after second dose of vaccine, the patient experienced big red block on the arm, allergic type reaction, and rash. Treatment medication included Cortisone cream.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events, big red block on the arm, allergic type reaction, and rash was unknown at the time of this report.; Reporter'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: Hypoaesthesia oral, Paraesthesia
Clinical narrative: A spontaneous report was received from a consumer concerning an  64 -year old,  female patient who received COVID-19 Vaccine (mRNA-1273) and experienced Bottom half of left lip got numb / Hypoaesthesia oral, Tip of tongue was tingling/ Paraesthesia. The patient's medical history, was not provided by the reporter, included no known allergies,  Concomitant medications was  not reported. On 3 Feb  2021 prior to the onset of the symptoms, the patient received their  first  of two planned doses of mRNA-1273 (Batch number 015M20A) intramuscularly in the arm for prophylaxis of COVID-19 infection. On 03 Mar  2021, after vaccination patient experienced  the events bottom half of left lip got numb, tip of tongue was tingling. Treatment information  provided was Zyrtex and advil. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the events  bottom half of left lip got numb, tip of tongue was tingling. Based on MSA comment, Paraethesia and Hypoaesthesia oral are Unlisted in CCDS.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing for 30-40 seconds; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a 66  Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273). The patient's medical history was not provided. No relevant concomitant medications were reported.   Patient stated that he received his 1st dose of the Moderna COVID 19 vaccine on 11JAN2021 at Health Department. Within a minute of receiving the vaccine he had difficulty breathing for 30-40 seconds. Patients stated that he did not take anything to alleviate the symptoms. Patient called his doctor's office and he was asked to call Moderna. Consent given for safety to follow up.Site for the injection was upper  right arm. The outcome of the event was unknown
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: roving itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (roving itchiness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PRURITUS (roving itchiness). At the time of the report, PRURITUS (roving itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient also took an unspecified cholesterol medication and inhaler concomitantly. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: non significant follow up received on 06-Jul-2021 in which email address and street address were updated.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site pain
Clinical narrative: Short of breath; Pain at injection site; A spontaneous report was received from a 57 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced short of breath/dyspnea and injection site pain.   The patient's medical history was not provided. The concomitant medications on use were also not provided.  On 11 Feb 2021, prior to the onset of the events, the patient received their dose of mRNA (Batch/Lot number: unknown) through intramuscular route of administration for prophylaxis of COVID-19 infection.  On unknown date, patient experienced pain at injection site and short of breath.  No laboratory data was provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events pain at injection site and short of breath were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Body aches; Soreness in arm; Fever 102.6 F; A spontaneous report was received from a Consumer concerning herself, a 58 year old female patient, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Fever 102.6 F/ Pyrexia, Body aches/ Pain, Soreness in arm/ Pain in extremity.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were unknown.  On 15 Feb 2021, approximately one day prior to the onset of events, the patient received their second of the two planned doses of mRNA-1273 (batch number: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced fever 102.6 F, body aches and soreness in arm. No Laboratory investigations were provided. No Treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events Fever 102.6 F/ Pyrexia, Body aches/ Pain, Soreness in arm/ Pain in extremity was considered unknown.  Based on sender comment, Soreness in arm change to Vaccination site pain and Listed in RSIs