chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Toothache; Aches and pains; Could not eat; Arm pain; lost of strenght, could not held a glass of water; Really really high fever; Nausea; Joint pain; Muscle pain; Fatigue; chils; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (Really really high fever), PAIN (Aches and pains), NAUSEA (Nausea) and FEEDING DISORDER (Could not eat) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 PAIN IN EXTREMITY (Arm pain), PYREXIA (Really really high fever), PAIN (Aches and pains), NAUSEA (Nausea), FEEDING DISORDER (Could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), ASTHENIA (lost of strenght, could not held a glass of water), FATIGUE (Fatigue), TOOTHACHE (Toothache) and CHILLS (chils). On 23-Jan-2021, CHILLS (chils) outcome was unknown. On 24-Jan-2021, PYREXIA (Really really high fever) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Arm pain), PAIN (Aches and pains), NAUSEA (Nausea), FEEDING DISORDER (Could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), ASTHENIA (lost of strenght, could not held a glass of water), FATIGUE (Fatigue) and TOOTHACHE (Toothache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Toothache; Aches and pains; Could not eat; Arm pain; lost of strenght, could not held a glass of water; Really really high fever; Nausea; Joint pain; Muscle pain; Fatigue; chils; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PYREXIA (Really really high fever), PAIN (Aches and pains), NAUSEA (Nausea) and FEEDING DISORDER (Could not eat) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 PAIN IN EXTREMITY (Arm pain), PYREXIA (Really really high fever), PAIN (Aches and pains), NAUSEA (Nausea), FEEDING DISORDER (Could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), ASTHENIA (lost of strenght, could not held a glass of water), FATIGUE (Fatigue), TOOTHACHE (Toothache) and CHILLS (chils). On 23-Jan-2021, CHILLS (chils) outcome was unknown. On 24-Jan-2021, PYREXIA (Really really high fever) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Arm pain), PAIN (Aches and pains), NAUSEA (Nausea), FEEDING DISORDER (Could not eat), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), ASTHENIA (lost of strenght, could not held a glass of water), FATIGUE (Fatigue) and TOOTHACHE (Toothache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache
Clinical narrative: Headache; cough; tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid), HEADACHE (Headache) and COUGH (cough) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced COVID-19 (tested positive for Covid). On an unknown date, the patient experienced HEADACHE (Headache) and COUGH (cough). At the time of the report, COVID-19 (tested positive for Covid) was resolving and HEADACHE (Headache) and COUGH (cough) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her arm; This spontaneous case was reported by an other and describes the occurrence of RASH (rash on her 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash on her arm). At the time of the report, RASH (rash on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypogeusia, Hyposmia, Injection site erythema, SARS-CoV-2 test
Clinical narrative: redness; lost his sense of taste and smell; lost his sense of taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGEUSIA (lost his sense of taste and smell), HYPOSMIA (lost his sense of taste and smell) and INJECTION SITE ERYTHEMA (redness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HYPOGEUSIA (lost his sense of taste and smell) and HYPOSMIA (lost his sense of taste and smell). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness). At the time of the report, HYPOGEUSIA (lost his sense of taste and smell) and HYPOSMIA (lost his sense of taste and smell) had not resolved and INJECTION SITE ERYTHEMA (redness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: (Negative) negative. On 20-Jan-2021, SARS-CoV-2 test: (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.     This case was linked to MOD-2021-014303 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: aches; significant fatigue; chills; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), FATIGUE (significant fatigue), CHILLS (chills) and PYREXIA (low grade fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aches), FATIGUE (significant fatigue), CHILLS (chills) and PYREXIA (low grade fever). At the time of the report, PAIN (aches), FATIGUE (significant fatigue), CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy in the arm; pain in left arm; Swelling in the arm; redness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in left arm), VACCINATION SITE SWELLING (Swelling in the arm), VACCINATION SITE ERYTHEMA (redness in the arm) and VACCINATION SITE PRURITUS (Itchy in the arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in left arm), VACCINATION SITE SWELLING (Swelling in the arm), VACCINATION SITE ERYTHEMA (redness in the arm) and VACCINATION SITE PRURITUS (Itchy in the arm). At the time of the report, VACCINATION SITE PAIN (pain in left arm), VACCINATION SITE SWELLING (Swelling in the arm), VACCINATION SITE ERYTHEMA (redness in the arm) and VACCINATION SITE PRURITUS (Itchy in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant  medication was not provided. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm was itchy; arm was swollen; arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen) and VACCINATION SITE ERYTHEMA (arm was red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure (the patient taking  blood pressure medication) and Anxiety (the patient taking anxiety depression medication).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen) and VACCINATION SITE ERYTHEMA (arm was red). At the time of the report, VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (arm was swollen) and VACCINATION SITE ERYTHEMA (arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included for blood pressure, depression and anxiety medication. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: intense burning in my neck side of face and side of head; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (intense burning in my neck side of face and side of head) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (intense burning in my neck side of face and side of head). At the time of the report, BURNING SENSATION (intense burning in my neck side of face and side of head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation
Clinical narrative: terrible constipation; stomach pains badly; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (terrible constipation) and ABDOMINAL PAIN UPPER (stomach pains badly) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced CONSTIPATION (terrible constipation) and ABDOMINAL PAIN UPPER (stomach pains badly). At the time of the report, CONSTIPATION (terrible constipation) and ABDOMINAL PAIN UPPER (stomach pains badly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: 9 days after receiving vaccine redness occurred; 9 days after receiving vaccine swelling occurred; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (9 days after receiving vaccine redness occurred) and VACCINATION SITE SWELLING (9 days after receiving vaccine swelling occurred) in a 67-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 reported).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (9 days after receiving vaccine redness occurred) and VACCINATION SITE SWELLING (9 days after receiving vaccine swelling occurred). At the time of the report, VACCINATION SITE ERYTHEMA (9 days after receiving vaccine redness occurred) and VACCINATION SITE SWELLING (9 days after receiving vaccine swelling occurred) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Tachycardia, Vaccination site pain
Clinical narrative: heart started beating a little faster; soreness around the injection site; slight fever; felt a little tired; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (heart started beating a little faster), VACCINATION SITE PAIN (soreness around the injection site), PYREXIA (slight fever) and FATIGUE (felt a little tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 TACHYCARDIA (heart started beating a little faster), VACCINATION SITE PAIN (soreness around the injection site), PYREXIA (slight fever) and FATIGUE (felt a little tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (heart started beating a little faster), VACCINATION SITE PAIN (soreness around the injection site), PYREXIA (slight fever) and FATIGUE (felt a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided Treatment information provided as ibuprofen
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: vaccination site warmth; vaccination site pruritus; redness on arm around injection site; vaccination site soreness; Vaccination site tenderness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE ERYTHEMA (redness on arm around injection site), VACCINATION SITE PAIN (vaccination site soreness) and VACCINATION SITE PAIN (Vaccination site tenderness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site tenderness). On 10-Jan-2021, the patient experienced VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE ERYTHEMA (redness on arm around injection site) and VACCINATION SITE PAIN (vaccination site soreness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Allergic reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (vaccination site warmth), VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE PAIN (vaccination site soreness) and VACCINATION SITE PAIN (Vaccination site tenderness) was resolving and VACCINATION SITE ERYTHEMA (redness on arm around injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Benadryl, in addition to the Zyrtec she takes every day.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: big swelling; L Arm Big Rash; sore arm; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE RASH (L Arm Big Rash), VACCINATION SITE SWELLING (big swelling) and VACCINATION SITE ERYTHEMA (red) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition was reported).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (L Arm Big Rash). On 19-Jan-2021, the patient experienced VACCINATION SITE SWELLING (big swelling). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE PAIN (sore arm), VACCINATION SITE RASH (L Arm Big Rash), VACCINATION SITE SWELLING (big swelling) and VACCINATION SITE ERYTHEMA (red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasal congestion, Peripheral coldness, Pyrexia
Clinical narrative: Hands got cold immediately; Scratchy throat; Nasal congestion; Chills; Low grade fever; Upper arm pain at the site of injection; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PERIPHERAL COLDNESS (Hands got cold immediately), THROAT IRRITATION (Scratchy throat), NASAL CONGESTION (Nasal congestion), CHILLS (Chills) and PYREXIA (Low grade fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020, Chills in April 2020, Pyrexia in April 2020, Nasal congestion in April 2020, Fatigue in April 2020, Throat irritation in April 2020 and Peripheral coldness in April 2020.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PERIPHERAL COLDNESS (Hands got cold immediately), THROAT IRRITATION (Scratchy throat), NASAL CONGESTION (Nasal congestion), CHILLS (Chills), PYREXIA (Low grade fever), VACCINATION SITE PAIN (Upper arm pain at the site of injection) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL COLDNESS (Hands got cold immediately), THROAT IRRITATION (Scratchy throat), NASAL CONGESTION (Nasal congestion), CHILLS (Chills), PYREXIA (Low grade fever), VACCINATION SITE PAIN (Upper arm pain at the site of injection) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: negative.     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.   Treatment and concomitant medications were not provided by reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Throat irritation, Vaccination site pain
Clinical narrative: Hands got cold immediately; Scratchy throat; Nasal congestion; Chills; Low grade fever; Upper arm pain at the site of injection; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PERIPHERAL COLDNESS (Hands got cold immediately), THROAT IRRITATION (Scratchy throat), NASAL CONGESTION (Nasal congestion), CHILLS (Chills) and PYREXIA (Low grade fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020, Chills in April 2020, Pyrexia in April 2020, Nasal congestion in April 2020, Fatigue in April 2020, Throat irritation in April 2020 and Peripheral coldness in April 2020.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PERIPHERAL COLDNESS (Hands got cold immediately), THROAT IRRITATION (Scratchy throat), NASAL CONGESTION (Nasal congestion), CHILLS (Chills), PYREXIA (Low grade fever), VACCINATION SITE PAIN (Upper arm pain at the site of injection) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL COLDNESS (Hands got cold immediately), THROAT IRRITATION (Scratchy throat), NASAL CONGESTION (Nasal congestion), CHILLS (Chills), PYREXIA (Low grade fever), VACCINATION SITE PAIN (Upper arm pain at the site of injection) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: negative.     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.   Treatment and concomitant medications were not provided by reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: reddness at area of injection; itchiness at area of injection; swollen area of injection; fever; soreness of arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever), PAIN IN EXTREMITY (soreness of arm), VACCINATION SITE ERYTHEMA (reddness at area of injection), VACCINATION SITE PRURITUS (itchiness at area of injection) and VACCINATION SITE SWELLING (swollen area of injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced PYREXIA (fever) and PAIN IN EXTREMITY (soreness of arm). On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (reddness at area of injection), VACCINATION SITE PRURITUS (itchiness at area of injection) and VACCINATION SITE SWELLING (swollen area of injection). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (fever), PAIN IN EXTREMITY (soreness of arm), VACCINATION SITE ERYTHEMA (reddness at area of injection), VACCINATION SITE PRURITUS (itchiness at area of injection) and VACCINATION SITE SWELLING (swollen area of injection) outcome was unknown.            Concomitant medications were not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain, Pyrexia
Clinical narrative: A spontaneous report was received from a consumer who was  73-year-old female patient who received the Moderna COVID-19 vaccine and felt very bad at night, shivering, fever, headache and body aches. Patient's medical history not provided. No concomitant medicines taken by the patient. On Jan 14, 2021 (approximately one day prior to the onset of the symptoms), patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection. On Feb 11, 2021 patient received their second of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection. On Jan 14, 2021, patient felt very bad at night, shivering, fever, headache and body aches. The symptoms is ongoing. Rechallenge is positive. No treatment taken by the patient. Action taken with mRNA-1273 not reported. The outcome of the events, felt very bad at night, shivering, fever, headache and body aches considered not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe rash in my upper body, back and chest; A spontaneous report was received from a Consumer concerning a  78 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event Rash.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 2- feb-2021, prior to the onset of the events, the patient received their first of planned dosesof mRNA-1273 (batch:012M20A)  Laboratory details was not provided.   treatment information was provided as amoxicillin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event is unknown  The reporter assessed the event(s), Rash as  related to study drug.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Lethargy, Myalgia
Clinical narrative: Feeling lethargic; Body aches; Sweats; Chills; Headache; fever of 101; A spontaneous report was received from a consumer concerning a 50 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lethargy, body aches, sweats, chills, headache and fever of 101.  The patient has a medical history covid. No relevant concomitant medication was reported.  On 22nd Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) in the right arm for prophylaxis of COVID-19 infection.  On 23rd Jan 2021, the patient experienced feeling lethargic, body aches, sweats, chills, headache, fever of 101 thought out the day. Symptoms of body aches, headache, fever of 101 ended on 24th Jan 2021 and symptoms of chills and sweats ended on 25th Jan 2021 but feeling of lethargic remained.  Treatment for the headache included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, body aches, headache, fever of 101, chills and sweats was resolved and feeling lethargic is not resolved.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling lethargic; Body aches; Sweats; Chills; Headache; fever of 101; A spontaneous report was received from a consumer concerning a 50 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lethargy, body aches, sweats, chills, headache and fever of 101.  The patient has a medical history covid. No relevant concomitant medication was reported.  On 22nd Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) in the right arm for prophylaxis of COVID-19 infection.  On 23rd Jan 2021, the patient experienced feeling lethargic, body aches, sweats, chills, headache, fever of 101 thought out the day. Symptoms of body aches, headache, fever of 101 ended on 24th Jan 2021 and symptoms of chills and sweats ended on 25th Jan 2021 but feeling of lethargic remained.  Treatment for the headache included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, body aches, headache, fever of 101, chills and sweats was resolved and feeling lethargic is not resolved.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for Covid-19; A spontaneous case was received to the safety reporting that patient had his 1st dose of the Moderna Covid-19 vaccine on 28Dec2020 at a healthcare facility. He had it on his left arm with unknown dose and route of administration. Lot number and expiration date were not provided. On 01Jan2021, he tested positive for Covid-19. He went ahead to get the 2nd dose which was given on 24Jan2021 in the same facility. It was administered on his left arm with unknown dose and route of administration. Lot number and expiration date not provided. Consent to follow up obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for Covid; Case reference number MOD-2021-014581 is a case report which refers to a 70 Years old Female patient.  The patient experienced tested positive for Covid which resulted in .  This occurred while participating in   The patients started Moderna COVID-19 Vaccine on  .  Some  8 days  later, the patient developed tested positive for Covid.'  Relevant laboratory results included   and relevant physical signs were  The patient experienced the following serious criteria:   The eventual diagnosis made was COVID-19 .  The patient was treated for the event with   The action taken for Moderna COVID-19 Vaccine was    .  The investigator considered the tested positive for Covid  did not declare related to the study drug/placebo.  In the investigators opinion other possible factors included and the patients age/history or other factors
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site joint erythema, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Red and itchy rash at injection site; vacciantion site pruritis; Vaccination site urticaria; A spontaneous report was received from a consumer concerning a 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (vaccination site joint erythema, vaccination site pruritus, vaccination site urticaria).  The patient's medical history was not provided. No relevant concomitant medications were reported.  on 03FEB2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) intramuscularly in the left upper arm deltoid for prophylaxis of COVID-19 infection.  Laboratory details are not provided.  No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: rash on left arm; injection site itching; pain at injection site; A spontaneous report was received from a consumer who was also a 49-years-old patient who received Moderna's COVID-19 vaccine and experienced pain at injection site, rash on left arm above injection and itching.  Patient's medical history was not provided, and concomitant medicines taken by the patient, is given  On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 04 feb 2021, the patient experienced pain at injection site, rash on left arm above injection and itching. Treatment included cortisone for 2-days  Caller received his first vaccine 29JAN2021 and experienced adverse events. Symptoms included pain at injection site, rash on left arm above injection and itching. Applied cortisone 2-days  Action taken with mRNA-1273 was not reported. The outcome of the events, pain at injection site, rash on left arm above injection and itching, was considered recovered/resolved
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; A spontaneous report was received from a  Consumer husband concerning a who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event Swollen lymph nodes.  The patient's medical history was not provided. No relevant concomitant medications were reported.    The vaccination details are not provided.  The event details are not provided  Laboratory details was not  provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event outcomes are not reported.  The reporter assessed the event, Swollen lymph nodes related to study drug.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disturbance in attention, Pyrexia
Clinical narrative: low grade fever; very confused; mental issues; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lowgrade fever and mental issues.  The patient's medical history was not reported. Concomitant medication was not reported.  25-JAN-2021, prior to the onset of the events, the patient received their first  planned dose of mRNA-1273 (lot/batch:029K20A)  for prophylaxis of COVID-19 infection.  26JAN2021, she had a low grade fever and also started having mental issues.Between Tuesday and Thursday, 28JAN2021, she had a total of 2 episodes of confusion.  Laboratory details - she had an MRI, bloodwork and urinalysis done. All tests came back normal and she was released from the hospital on 28JAN2021.  Treatment information -Tylenol was given to the patient.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events pyrexia,mental issues,confusional state are  recovered/resolved.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Itching near the injection site; Rash near the injection site; Hot to touch near the injection site; A spontaneous report was received from a consumer concerning a female patient of 95 years of age,who was administered with Moderna's covid-19 vaccine and experienced itching and rash near the injection site and hot to touch near the injection site.  Patient's medical history was not provided.No relevant concomitant medications were mentioned.  On 05-FEB-2021,patient received the first of two planned doses of mRNA-1273(Lot number:unknown) for prophylaxis of covid-19 infection.  8 days later, On 13-FEB-2021,the reporter mentioned that  her mother started experiencing "moderna covid arm" reactions. Treatment options included Benadryl and ice packs.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Pain
Clinical narrative: Fever; Chills; aches; Fatigue; Terrible cough; COVID-19; Case reference number MOD-2021-014599 is a spontaneous case report sent by a Other on 16-FEB-2021 00:00:00 .  The patients past medical history included: No adverse event   . .  On the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  1 day later,  the patient developed Fever. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed COVID-19,Chills,aches,Fatigue,Terrible cough. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Pyrexia . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Other did not declare any relatedness between Fever and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Other,  Age-  ,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; aches; Fatigue; Terrible cough; COVID-19; Case reference number MOD-2021-014599 is a spontaneous case report sent by a Other on 16-FEB-2021 00:00:00 .  The patients past medical history included: No adverse event   . .  On the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  1 day later,  the patient developed Fever. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed COVID-19,Chills,aches,Fatigue,Terrible cough. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Pyrexia . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Other did not declare any relatedness between Fever and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Other,  Age-  ,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: red mark at the injection site; itching at the injection site; A regulatory authority report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed vaccination site redness and itching.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin and folic acid.  On 04 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 031L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On unknown date, the patient developed vaccination site redness and itching. Treatment for the event, was not reported.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, vaccination site redness and itching, was considered unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; A spontaneous report was received from a Consumer concerning a 64 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in arms.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On the same day, The patient experienced the event arm soreness.  Treatment details was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event pain in arm was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain in extremity
Clinical narrative: Very nauseous; Arm hurt and was tender; Had chills; Felt tired; A spontaneous report was received on 14-Feb-2021 from a non healthcare professional concerning a 85 years old female patient who received Moderna's COVID-19(mRNA-1273) vaccine and experienced chills, felt tired, very nauseous, arm hurt and was tender.  The patient medical history was not provided. No concomitant medications were reported.  On 13-Feb-2021, one day prior to the onset of events, patient received mRNA-1273(Batch:013M20A) intramuscularly on her left arm for the prophylaxis of covid-19 infection.  On 13-Feb-2021, patient experienced chills, felt tired, very nauseous, arm hurt and was tender.  No laboratory information was provided. Treatment information includes ginger ale and crackers.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were recovered/resolved.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itchiness at the injection site; Redness at the injection site; A spontaneous report was received from a consumer concerning a 54 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchiness at injection site and redness at injection site. The patient's medical history was not provided.  Concomitant medication not provided. On 21-JAN-2021, prior to the onset of the events, the patient received their unknown if first or second of two planned doses of mRNA-1273 (lot/batch: not provided) intramuscularly on left arm for prophylaxis of COVID-19 infection.  On 28-JAN-2021, The patient experienced itchiness at injection site and redness at injection site.  No lab details provided. No treatment was mentioned. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was unknown as per report.  The reporter assessed the event, [itchiness at injection site and redness at injection site], as unknown to study drug.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle ache, can barely move; A spontaneous report was received from a consumer concerning a female patient of 76 years of age ,who was administered with Moderna's covid-19 vaccine and experienced muscle ache and can barely move.  Patient was diagnosed with covid-19 infection on November 15.Concomitant medications included Simvastatin, Multivitamin, Calcium, Vitamin D, and a blood pressure medicine.  On 14-FEB-2021,prior to the onset of events,the patient received mNRA-1273(Lot number:039K20A) for prophylaxis of covid-19 infection.  On 15-FEB-2021,patient started experiencing Muscle ache and can barely move.Treatment medication included Tylenol.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Mild reaction on my arm; A spontaneous report was received from a consumer concerning a 80-year-old, male patient, participating in the Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who had experienced mild reaction on arm.  The patient's medical history, is not provided by the reporter.  Concomitant medications were not reported.   The patient received their first of two planned dose of mRNA-1273 on 15 Jan 2021. Prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in(Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Experienced mild reaction on arm.   No relevant lab data is reported by the reporter.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of event, mild reaction on arm was unknown.   The reporter did not provide an assessment for the events,mild reaction on arm.  Since no Seriousness criteria is reported , hence the case is considered to be Non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore arm; A spontaneous report was received from a Consumer concerning a  58 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced event Arthralgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 6-feb-2021prior to the onset of the events, the patient received their first planned dose of mRNA-1273. The lot no. and location of vaccination injected is unknown  Laboratory details was not provided.  No treatment information was provided. asked can she take antibiotics for other problem.  Action taken with mRNA-1273 in response to the events was not reported.    The event sore arm outcome is unknown  The reporter assessed the event Sore arm as  related to study drug.