chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Nausea, Pain, Productive cough
Clinical narrative: Body aches; Tested positive for Covid 19; Feeling bad; Throat was bothering her with phlegm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), COVID-19 (Tested positive for Covid 19), FEELING ABNORMAL (Feeling bad), PRODUCTIVE COUGH (Throat was bothering her with phlegm) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21N) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), COVID-19 (Tested positive for Covid 19), FEELING ABNORMAL (Feeling bad), PRODUCTIVE COUGH (Throat was bothering her with phlegm) and NAUSEA (Nausea). At the time of the report, PAIN (Body aches), COVID-19 (Tested positive for Covid 19), FEELING ABNORMAL (Feeling bad), PRODUCTIVE COUGH (Throat was bothering her with phlegm) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter contact details was updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Body aches; Tested positive for Covid 19; Feeling bad; Throat was bothering her with phlegm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), COVID-19 (Tested positive for Covid 19), FEELING ABNORMAL (Feeling bad), PRODUCTIVE COUGH (Throat was bothering her with phlegm) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21N) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), COVID-19 (Tested positive for Covid 19), FEELING ABNORMAL (Feeling bad), PRODUCTIVE COUGH (Throat was bothering her with phlegm) and NAUSEA (Nausea). At the time of the report, PAIN (Body aches), COVID-19 (Tested positive for Covid 19), FEELING ABNORMAL (Feeling bad), PRODUCTIVE COUGH (Throat was bothering her with phlegm) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter contact details was updated.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash around the injection), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red circle) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Clotting disorder. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash around the injection), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red circle). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (rash around the injection), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red circle) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Swelling
Clinical narrative: Swollen; Tiredness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SWELLING (Swollen) and FATIGUE (Tiredness) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tiredness). On 31-Mar-2021, the patient experienced SWELLING (Swollen). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), SWELLING (Swollen) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Urticaria, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and hives recurred on her arm; Hives on arm; Red injection site; Raised injection site; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm), ERYTHEMA (Redness and hives recurred on her arm), URTICARIA (Hives on arm), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Raised injection site) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm), URTICARIA (Hives on arm), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Raised injection site). On an unknown date, the patient experienced ERYTHEMA (Redness and hives recurred on her arm). On 26-Mar-2021, PAIN IN EXTREMITY (Soreness in arm), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Raised injection site) had resolved. At the time of the report, ERYTHEMA (Redness and hives recurred on her arm) and URTICARIA (Hives on arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The symptoms went away for a day and then the redness and hives recurred on her arm.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site discolouration, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Injection site was itchy, had a raised hive-like area and was red; Injection site was itchy, had a raised hive-like area and was red; Injection site was black and blue; Injection site was swollen, red, hot, and hurt; Injection site was swollen, red, hot, and hurt; Injection site was swollen, red, hot, and hurt; Injection site was swollen, red, hot, and hurt; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (Injection site was swollen, red, hot, and hurt), URTICARIA (Injection site was itchy, had a raised hive-like area and was red), VACCINATION SITE DISCOLOURATION (Injection site was black and blue), VACCINATION SITE PRURITUS (Injection site was itchy, had a raised hive-like area and was red) and VACCINATION SITE SWELLING (Injection site was swollen, red, hot, and hurt) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was swollen, red, hot, and hurt), VACCINATION SITE SWELLING (Injection site was swollen, red, hot, and hurt), VACCINATION SITE ERYTHEMA (Injection site was swollen, red, hot, and hurt) and VACCINATION SITE PAIN (Injection site was swollen, red, hot, and hurt). On 27-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Injection site was black and blue). On 30-Mar-2021, the patient experienced URTICARIA (Injection site was itchy, had a raised hive-like area and was red) and VACCINATION SITE PRURITUS (Injection site was itchy, had a raised hive-like area and was red). On 27-Mar-2021, VACCINATION SITE WARMTH (Injection site was swollen, red, hot, and hurt) and VACCINATION SITE PAIN (Injection site was swollen, red, hot, and hurt) had resolved. On 29-Mar-2021, VACCINATION SITE DISCOLOURATION (Injection site was black and blue) had resolved. At the time of the report, URTICARIA (Injection site was itchy, had a raised hive-like area and was red), VACCINATION SITE PRURITUS (Injection site was itchy, had a raised hive-like area and was red) and VACCINATION SITE SWELLING (Injection site was swollen, red, hot, and hurt) had not resolved and VACCINATION SITE ERYTHEMA (Injection site was swollen, red, hot, and hurt) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site was itchy, had a raised hive-like area and was red; Injection site was itchy, had a raised hive-like area and was red; Injection site was black and blue; Injection site was swollen, red, hot, and hurt; Injection site was swollen, red, hot, and hurt; Injection site was swollen, red, hot, and hurt; Injection site was swollen, red, hot, and hurt; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (Injection site was swollen, red, hot, and hurt), URTICARIA (Injection site was itchy, had a raised hive-like area and was red), VACCINATION SITE DISCOLOURATION (Injection site was black and blue), VACCINATION SITE PRURITUS (Injection site was itchy, had a raised hive-like area and was red) and VACCINATION SITE SWELLING (Injection site was swollen, red, hot, and hurt) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was swollen, red, hot, and hurt), VACCINATION SITE SWELLING (Injection site was swollen, red, hot, and hurt), VACCINATION SITE ERYTHEMA (Injection site was swollen, red, hot, and hurt) and VACCINATION SITE PAIN (Injection site was swollen, red, hot, and hurt). On 27-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Injection site was black and blue). On 30-Mar-2021, the patient experienced URTICARIA (Injection site was itchy, had a raised hive-like area and was red) and VACCINATION SITE PRURITUS (Injection site was itchy, had a raised hive-like area and was red). On 27-Mar-2021, VACCINATION SITE WARMTH (Injection site was swollen, red, hot, and hurt) and VACCINATION SITE PAIN (Injection site was swollen, red, hot, and hurt) had resolved. On 29-Mar-2021, VACCINATION SITE DISCOLOURATION (Injection site was black and blue) had resolved. At the time of the report, URTICARIA (Injection site was itchy, had a raised hive-like area and was red), VACCINATION SITE PRURITUS (Injection site was itchy, had a raised hive-like area and was red) and VACCINATION SITE SWELLING (Injection site was swollen, red, hot, and hurt) had not resolved and VACCINATION SITE ERYTHEMA (Injection site was swollen, red, hot, and hurt) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Visual impairment
Clinical narrative: Vision changes; Constant headaches, some are worse then the rest; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision changes) and HEADACHE (Constant headaches, some are worse then the rest) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (Constant headaches, some are worse then the rest). On 01-Apr-2021, the patient experienced VISUAL IMPAIRMENT (Vision changes). At the time of the report, VISUAL IMPAIRMENT (Vision changes) and HEADACHE (Constant headaches, some are worse then the rest) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.  Concomitant product use was not provided by the reporter.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: feeling different; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling different) and DIZZINESS (dizzy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202-A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FEELING ABNORMAL (feeling different) and DIZZINESS (dizzy). At the time of the report, FEELING ABNORMAL (feeling different) and DIZZINESS (dizzy) 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.   Treatment information was not provided.  Concomitants were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthropod sting, Papule, Peripheral swelling, Pruritus
Clinical narrative: Arm is swollen; Like a bee sting; Large bump; Arm is itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), ARTHROPOD STING (Like a bee sting), PAPULE (Large bump) and PRURITUS (Arm is itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), ARTHROPOD STING (Like a bee sting), PAPULE (Large bump) and PRURITUS (Arm is itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 05-Mar-2021, PERIPHERAL SWELLING (Arm is swollen), ARTHROPOD STING (Like a bee sting), PAPULE (Large bump) and PRURITUS (Arm is itchy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information also included ice packs.   This case was linked to MOD-2021-066040 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: Legs feel heavy; Walking through sludge; Injection site is now itchy more like a mosquito bite; Chills; Shot felt more uncomfortable; Liquid going in a vein in her arm; Feeling tired; Dull headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Shot felt more uncomfortable), VASCULAR COMPRESSION (Liquid going in a vein in her arm), LIMB DISCOMFORT (Legs feel heavy), GAIT DISTURBANCE (Walking through sludge) and VACCINATION SITE PRURITUS (Injection site is now itchy more like a mosquito bite) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FEELING ABNORMAL (Shot felt more uncomfortable), VASCULAR COMPRESSION (Liquid going in a vein in her arm), FATIGUE (Feeling tired) and HEADACHE (Dull headache). On 31-Mar-2021, the patient experienced CHILLS (Chills). On 01-Apr-2021, the patient experienced LIMB DISCOMFORT (Legs feel heavy), GAIT DISTURBANCE (Walking through sludge) and VACCINATION SITE PRURITUS (Injection site is now itchy more like a mosquito bite). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 30-Mar-2021, FEELING ABNORMAL (Shot felt more uncomfortable), VASCULAR COMPRESSION (Liquid going in a vein in her arm) and HEADACHE (Dull headache) had resolved. On 31-Mar-2021, FATIGUE (Feeling tired) and CHILLS (Chills) had resolved. At the time of the report, LIMB DISCOMFORT (Legs feel heavy), GAIT DISTURBANCE (Walking through sludge) and VACCINATION SITE PRURITUS (Injection site is now itchy more like a mosquito bite) outcome was unknown.            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.  Concomitant product use was not provided by the reporter.  Treatment information also included ice packs   This case was linked to MOD-2021-066039 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pruritus, Vascular compression
Clinical narrative: Legs feel heavy; Walking through sludge; Injection site is now itchy more like a mosquito bite; Chills; Shot felt more uncomfortable; Liquid going in a vein in her arm; Feeling tired; Dull headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Shot felt more uncomfortable), VASCULAR COMPRESSION (Liquid going in a vein in her arm), LIMB DISCOMFORT (Legs feel heavy), GAIT DISTURBANCE (Walking through sludge) and VACCINATION SITE PRURITUS (Injection site is now itchy more like a mosquito bite) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FEELING ABNORMAL (Shot felt more uncomfortable), VASCULAR COMPRESSION (Liquid going in a vein in her arm), FATIGUE (Feeling tired) and HEADACHE (Dull headache). On 31-Mar-2021, the patient experienced CHILLS (Chills). On 01-Apr-2021, the patient experienced LIMB DISCOMFORT (Legs feel heavy), GAIT DISTURBANCE (Walking through sludge) and VACCINATION SITE PRURITUS (Injection site is now itchy more like a mosquito bite). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 30-Mar-2021, FEELING ABNORMAL (Shot felt more uncomfortable), VASCULAR COMPRESSION (Liquid going in a vein in her arm) and HEADACHE (Dull headache) had resolved. On 31-Mar-2021, FATIGUE (Feeling tired) and CHILLS (Chills) had resolved. At the time of the report, LIMB DISCOMFORT (Legs feel heavy), GAIT DISTURBANCE (Walking through sludge) and VACCINATION SITE PRURITUS (Injection site is now itchy more like a mosquito bite) outcome was unknown.            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.  Concomitant product use was not provided by the reporter.  Treatment information also included ice packs   This case was linked to MOD-2021-066039 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Readness-Left arm; itchy - left arm; swollen - left arm; hard - left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Readness-Left arm), VACCINATION SITE PRURITUS (itchy - left arm), VACCINATION SITE SWELLING (swollen - left arm) and VACCINATION SITE DISCOMFORT (hard - left arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Readness-Left arm), VACCINATION SITE PRURITUS (itchy - left arm), VACCINATION SITE SWELLING (swollen - left arm) and VACCINATION SITE DISCOMFORT (hard - left arm). On 02-Apr-2021, VACCINATION SITE PRURITUS (itchy - left arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Readness-Left arm) had not resolved and VACCINATION SITE SWELLING (swollen - left arm) and VACCINATION SITE DISCOMFORT (hard - left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included two tylenol.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Gingival discomfort, Pain in extremity, Pruritus
Clinical narrative: Issues with my gum; Itching; sore; redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness), PAIN IN EXTREMITY (Sore) and GINGIVAL DISCOMFORT (Issues with my gum) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.  Concomitant products included PANTOPRAZOLE, LINACLOTIDE (LINZESS), SIMVASTATIN, LORAZEPAM and FAMOTIDINE for an unknown indication.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching), ERYTHEMA (Redness), PAIN IN EXTREMITY (Sore) and GINGIVAL DISCOMFORT (Issues with my gum). At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness), PAIN IN EXTREMITY (Sore) and GINGIVAL DISCOMFORT (Issues with my gum) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Pantoprazole,Lizzness,Simvastatin,Lorazepam Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up report received on 24-June-2021 event outcome updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain
Clinical narrative: Sore throat; Chills; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and HEADACHE (Severe headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and HEADACHE (Severe headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and HEADACHE (Severe headache) had not resolved.        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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysgeusia, Oral discomfort, Palpitations, Tongue discomfort
Clinical narrative: mouth on fire; tongue on fire; heart racing; chest felt funny; metal taste in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (mouth on fire), TONGUE DISCOMFORT (tongue on fire), PALPITATIONS (heart racing), CHEST DISCOMFORT (chest felt funny) and DYSGEUSIA (metal taste in the mouth) in a 68-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. Concurrent medical conditions included Steroid therapy NOS, Allergy, Hormone therapy, Allergy and Shellfish allergy.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ORAL DISCOMFORT (mouth on fire), TONGUE DISCOMFORT (tongue on fire), PALPITATIONS (heart racing), CHEST DISCOMFORT (chest felt funny) and DYSGEUSIA (metal taste in the mouth). At the time of the report, ORAL DISCOMFORT (mouth on fire), TONGUE DISCOMFORT (tongue on fire), PALPITATIONS (heart racing), CHEST DISCOMFORT (chest felt funny) and DYSGEUSIA (metal taste in the mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Lymphoedema, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), RASH ERYTHEMATOUS (red rash on arm going down from the injection site), VACCINATION SITE PAIN (sore) and VACCINATION SITE ERYTHEMA (red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Mar-2021, the patient experienced PYREXIA (fever). On 16-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash on arm going down from the injection site), VACCINATION SITE PAIN (sore), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (felt hot). On 17-Mar-2021, the patient experienced RASH (rash spread farther down arm), FEELING HOT (hot), PRURITUS (itchy), PAIN IN EXTREMITY (painful) and LYMPHOEDEMA (lymphedema). On an unknown date, the patient experienced RASH ERYTHEMATOUS (red). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), RASH ERYTHEMATOUS (red rash on arm going down from the injection site), VACCINATION SITE PAIN (sore), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE WARMTH (felt hot), RASH (rash spread farther down arm), FEELING HOT (hot), RASH ERYTHEMATOUS (red), PRURITUS (itchy), PAIN IN EXTREMITY (painful) and LYMPHOEDEMA (lymphedema) outcome was unknown. Not Provided. Concomitant product use was not provided by the reporter. Treatment information included tylenol and antibiotics.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), RASH ERYTHEMATOUS (red rash on arm going down from the injection site), VACCINATION SITE PAIN (sore) and VACCINATION SITE ERYTHEMA (red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Mar-2021, the patient experienced PYREXIA (fever). On 16-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red rash on arm going down from the injection site), VACCINATION SITE PAIN (sore), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (felt hot). On 17-Mar-2021, the patient experienced RASH (rash spread farther down arm), FEELING HOT (hot), PRURITUS (itchy), PAIN IN EXTREMITY (painful) and LYMPHOEDEMA (lymphedema). On an unknown date, the patient experienced RASH ERYTHEMATOUS (red). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (fever), RASH ERYTHEMATOUS (red rash on arm going down from the injection site), VACCINATION SITE PAIN (sore), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE WARMTH (felt hot), RASH (rash spread farther down arm), FEELING HOT (hot), RASH ERYTHEMATOUS (red), PRURITUS (itchy), PAIN IN EXTREMITY (painful) and LYMPHOEDEMA (lymphedema) outcome was unknown. Not Provided. Concomitant product use was not provided by the reporter. Treatment information included tylenol and antibiotics.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test positive
Clinical narrative: little bit of cough left; Tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) and COUGH (little bit of cough left) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19). On an unknown date, the patient experienced COUGH (little bit of cough left). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) and COUGH (little bit of cough left) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breast feeding) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 041L20A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breast feeding). The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE VIA BREAST MILK (Breast feeding) outcome was unknown.            Concomitant medication information was not reported. Treatment information as not reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting projectile
Clinical narrative: Diarrhea; Projectile vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VOMITING PROJECTILE (Projectile vomiting) and NAUSEA (Nausea) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), VOMITING PROJECTILE (Projectile vomiting) and NAUSEA (Nausea). The patient was treated with GLUCOSE, POTASSIUM CHLORIDE, SODIUM CITRATE ACID (PEDIALYTE [GLUCOSE;POTASSIUM CHLORIDE;SODIUM CITRATE ACID]) ongoing from 19-Jan-2021 for Adverse event, at an unspecified dose and frequency. On 22-Jan-2021, DIARRHOEA (Diarrhea), VOMITING PROJECTILE (Projectile vomiting) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not provided   BRAT diet was given as treatment for events   This case was linked to MOD21-14857 (E2B Linked Report).; Sender's Comments:  MOD21-14857:Wife's case
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive second Moderna shot within 35 days of the first shot; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive second Moderna shot within 35 days of the first shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 PRODUCT DOSE OMISSION ISSUE (Patient did not receive second Moderna shot within 35 days of the first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive second Moderna shot within 35 days of the first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: arm swollen and hard; arm pain; molars hurt; feeling like a full cement truck ran over me; sleeping all day; chills; fever (101.2); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen and hard), PAIN IN EXTREMITY (arm pain), TOOTHACHE (molars hurt), FEELING ABNORMAL (feeling like a full cement truck ran over me) and SOMNOLENCE (sleeping all day) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swollen and hard), PAIN IN EXTREMITY (arm pain), TOOTHACHE (molars hurt), FEELING ABNORMAL (feeling like a full cement truck ran over me), SOMNOLENCE (sleeping all day), CHILLS (chills) and PYREXIA (fever (101.2)). At the time of the report, PERIPHERAL SWELLING (arm swollen and hard), PAIN IN EXTREMITY (arm pain), TOOTHACHE (molars hurt), FEELING ABNORMAL (feeling like a full cement truck ran over me), SOMNOLENCE (sleeping all day), CHILLS (chills) and PYREXIA (fever (101.2)) outcome was unknown.            There was no concomitant list.  Treatment included water and 7-up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Toothache
Clinical narrative: arm swollen and hard; arm pain; molars hurt; feeling like a full cement truck ran over me; sleeping all day; chills; fever (101.2); This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen and hard), PAIN IN EXTREMITY (arm pain), TOOTHACHE (molars hurt), FEELING ABNORMAL (feeling like a full cement truck ran over me) and SOMNOLENCE (sleeping all day) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swollen and hard), PAIN IN EXTREMITY (arm pain), TOOTHACHE (molars hurt), FEELING ABNORMAL (feeling like a full cement truck ran over me), SOMNOLENCE (sleeping all day), CHILLS (chills) and PYREXIA (fever (101.2)). At the time of the report, PERIPHERAL SWELLING (arm swollen and hard), PAIN IN EXTREMITY (arm pain), TOOTHACHE (molars hurt), FEELING ABNORMAL (feeling like a full cement truck ran over me), SOMNOLENCE (sleeping all day), CHILLS (chills) and PYREXIA (fever (101.2)) outcome was unknown.            There was no concomitant list.  Treatment included water and 7-up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: pain on the arm; Swollen Lymphs on the same side of the arm as the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the arm) and LYMPHADENOPATHY (Swollen Lymphs on the same side of the arm as the injection) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain on the arm) and LYMPHADENOPATHY (Swollen Lymphs on the same side of the arm as the injection). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain on the arm) and LYMPHADENOPATHY (Swollen Lymphs on the same side of the arm as the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Upon internal review on 4-Aug-21, the age was corrected to 47 years
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products, Pain in extremity, Wrong product administered
Clinical narrative: Pain in arm; received first dose of Moderna COVID-19 vaccine after receiving two doses of Pfizer COVID-19 vaccine; Moderna Covid-19 dose accidentally given instead of second dose of Shingrix; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Apr-2021. The most recent information was received on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna Covid-19 dose accidentally given instead of second dose of Shingrix), PAIN IN EXTREMITY (Pain in arm) and INTERCHANGE OF VACCINE PRODUCTS (received first dose of Moderna COVID-19 vaccine after receiving two doses of Pfizer COVID-19 vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Heart disease, unspecified. Concomitant products included VENLAFAXINE, OMEPRAZOLE, FENOFIBRATE, ATORVASTATIN, LOSARTAN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CARVEDILOL.   On 06-Feb-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1st dose. On 27-Feb-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 2nd dose. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Moderna Covid-19 dose accidentally given instead of second dose of Shingrix) and INTERCHANGE OF VACCINE PRODUCTS (received first dose of Moderna COVID-19 vaccine after receiving two doses of Pfizer COVID-19 vaccine). On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 01-Apr-2021, WRONG PRODUCT ADMINISTERED (Moderna Covid-19 dose accidentally given instead of second dose of Shingrix) and INTERCHANGE OF VACCINE PRODUCTS (received first dose of Moderna COVID-19 vaccine after receiving two doses of Pfizer COVID-19 vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm) 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.   Treatment information was not provided.  This report refers to a case of wrong product administered for mRNA-1273 with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: TCR included no new information. On 22-Apr-2021: events updated; Sender's Comments: This report refers to a case of wrong product administered for mRNA-1273 with no associated AEs.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: minor throat swelling; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (minor throat swelling) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PHARYNGEAL SWELLING (minor throat swelling). On 20-Mar-2021, PHARYNGEAL SWELLING (minor throat swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and NAUSEA (Nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, FENOFIBRATE, LOSARTAN and Allergy pill for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment Tylenol (both occasions)
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Fever that comes and goes; Nausea; Chills; Marked exhaustion (been in bed all day); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever that comes and goes), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Marked exhaustion (been in bed all day)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ATORVASTATIN and FENOFIBRATE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever that comes and goes), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Marked exhaustion (been in bed all day)). At the time of the report, PYREXIA (Fever that comes and goes), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Marked exhaustion (been in bed all day)) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  Products known to have been used by the patient, within two weeks prior to the event, included allergy pills(unspecified)  Treatment of the events included, paracetamol.