chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Cough, SARS-CoV-2 test
Clinical narrative: Bronchitis; COVID-19; Bad cough; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), COVID-19 (COVID-19) and COUGH (Bad cough) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (Bronchitis), COVID-19 (COVID-19) and COUGH (Bad cough). The patient was treated with AZITHROMYCIN (ZITHROMAX) at an unspecified dose and frequency; DEXAMETHASONE at an unspecified dose and frequency and BENZONATATE at an unspecified dose and frequency. At the time of the report, BRONCHITIS (Bronchitis), COVID-19 (COVID-19) and COUGH (Bad cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were provided. Treatment medications included Supplements. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via skin contact, Vaccination site discharge
Clinical narrative: Vaccine leaked out of my arm; Vaccine ran down about 4 inches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DISCHARGE (Vaccine leaked out of my arm) and EXPOSURE VIA SKIN CONTACT (Vaccine ran down about 4 inches) 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 25-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 VACCINATION SITE DISCHARGE (Vaccine leaked out of my arm) and EXPOSURE VIA SKIN CONTACT (Vaccine ran down about 4 inches). At the time of the report, VACCINATION SITE DISCHARGE (Vaccine leaked out of my arm) and EXPOSURE VIA SKIN CONTACT (Vaccine ran down about 4 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.    Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up information received on 29-APR-2021 contains non-significant information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: severe pain at the upper right arm /sore arm; sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain at the upper right arm /sore arm) and SOMNOLENCE (sleepiness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (severe pain at the upper right arm /sore arm) and SOMNOLENCE (sleepiness). At the time of the report, PAIN IN EXTREMITY (severe pain at the upper right arm /sore arm) and SOMNOLENCE (sleepiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate increased, Injection site rash, Rash
Clinical narrative: blood pressure elevation; heart rate is really high up to 100 at rest; rash on hands; injection site rashes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE MEASUREMENT (blood pressure elevation), HEART RATE INCREASED (heart rate is really high up to 100 at rest), RASH (rash on hands) and INJECTION SITE RASH (injection site rashes) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced BLOOD PRESSURE MEASUREMENT (blood pressure elevation), HEART RATE INCREASED (heart rate is really high up to 100 at rest), RASH (rash on hands) and INJECTION SITE RASH (injection site rashes). At the time of the report, BLOOD PRESSURE MEASUREMENT (blood pressure elevation), HEART RATE INCREASED (heart rate is really high up to 100 at rest), RASH (rash on hands) and INJECTION SITE RASH (injection site rashes) outcome was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Granulocyte count increased, Red blood cell sedimentation rate increased
Clinical narrative: high Sediment rate= 35; high Granulocyte count; A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high sediment rate= 35/red blood cell count increased, high granulocyte count/granulocyte count increased.  The patient's medical history was not provided. Concomitant medications reported were Imuran, Methotrexate for sarcoidosis and Levofloxacin, Prednisone 1mg tablet, Potassium Chloride 20meq BID for drug use for unknown indication.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) high Sediment rate= 35, high Granulocyte count.  Treatment details included Levaquin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), high sediment rate= 35, high granulocyte count was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Neurological symptom
Clinical narrative: Physical reaction; Neurological symptom; This spontaneous case was reported by a health care professional and describes the occurrence of NEUROLOGICAL SYMPTOM (Neurological symptom) and MALAISE (Physical reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (Neurological symptom) and MALAISE (Physical reaction). At the time of the report, NEUROLOGICAL SYMPTOM (Neurological symptom) and MALAISE (Physical reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to the events was not provided.   Reporter did not allow further contact
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall, Injection site pain, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: fell, did not have strength to get up, had to crawl; OVERALL WEAKNESS; HIP BONE HURT; NECK WAS STIFF AND SORE; NECK WAS STIFF AND SORE; LEFT ARM HURT; TENDER INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell, did not have strength to get up, had to crawl), ASTHENIA (OVERALL WEAKNESS), MUSCULOSKELETAL DISCOMFORT (HIP BONE HURT), MUSCULOSKELETAL STIFFNESS (NECK WAS STIFF AND SORE) and NECK PAIN (NECK WAS STIFF AND SORE) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced FALL (fell, did not have strength to get up, had to crawl), ASTHENIA (OVERALL WEAKNESS), MUSCULOSKELETAL DISCOMFORT (HIP BONE HURT), MUSCULOSKELETAL STIFFNESS (NECK WAS STIFF AND SORE), NECK PAIN (NECK WAS STIFF AND SORE), INJECTION SITE PAIN (LEFT ARM HURT) and INJECTION SITE PAIN (TENDER INJECTION SITE). On 26-Feb-2021, FALL (fell, did not have strength to get up, had to crawl), ASTHENIA (OVERALL WEAKNESS), MUSCULOSKELETAL DISCOMFORT (HIP BONE HURT), MUSCULOSKELETAL STIFFNESS (NECK WAS STIFF AND SORE), NECK PAIN (NECK WAS STIFF AND SORE), INJECTION SITE PAIN (LEFT ARM HURT) and INJECTION SITE PAIN (TENDER INJECTION SITE) had resolved.            No treatment was provided by the reporter. No concomitant medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Followup was received. No significant information was received.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: fell, did not have strength to get up, had to crawl; OVERALL WEAKNESS; HIP BONE HURT; NECK WAS STIFF AND SORE; NECK WAS STIFF AND SORE; LEFT ARM HURT; TENDER INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell, did not have strength to get up, had to crawl), ASTHENIA (OVERALL WEAKNESS), MUSCULOSKELETAL DISCOMFORT (HIP BONE HURT), MUSCULOSKELETAL STIFFNESS (NECK WAS STIFF AND SORE) and NECK PAIN (NECK WAS STIFF AND SORE) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced FALL (fell, did not have strength to get up, had to crawl), ASTHENIA (OVERALL WEAKNESS), MUSCULOSKELETAL DISCOMFORT (HIP BONE HURT), MUSCULOSKELETAL STIFFNESS (NECK WAS STIFF AND SORE), NECK PAIN (NECK WAS STIFF AND SORE), INJECTION SITE PAIN (LEFT ARM HURT) and INJECTION SITE PAIN (TENDER INJECTION SITE). On 26-Feb-2021, FALL (fell, did not have strength to get up, had to crawl), ASTHENIA (OVERALL WEAKNESS), MUSCULOSKELETAL DISCOMFORT (HIP BONE HURT), MUSCULOSKELETAL STIFFNESS (NECK WAS STIFF AND SORE), NECK PAIN (NECK WAS STIFF AND SORE), INJECTION SITE PAIN (LEFT ARM HURT) and INJECTION SITE PAIN (TENDER INJECTION SITE) had resolved.            No treatment was provided by the reporter. No concomitant medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Followup was received. No significant information was received.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue
Clinical narrative: stomach ache - 21 Feb 2021; diarrhea - 21 Feb 2021; chills - 21 Feb 2021; fatigue - 21 Feb 2021; very very tired - 21 Feb 2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache - 21 Feb 2021), DIARRHOEA (diarrhea - 21 Feb 2021), CHILLS (chills - 21 Feb 2021), FATIGUE (fatigue - 21 Feb 2021) and FATIGUE (very very tired - 21 Feb 2021) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache - 21 Feb 2021), DIARRHOEA (diarrhea - 21 Feb 2021), CHILLS (chills - 21 Feb 2021), FATIGUE (fatigue - 21 Feb 2021) and FATIGUE (very very tired - 21 Feb 2021). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache - 21 Feb 2021), DIARRHOEA (diarrhea - 21 Feb 2021), CHILLS (chills - 21 Feb 2021) and FATIGUE (fatigue - 21 Feb 2021) had resolved and FATIGUE (very very tired - 21 Feb 2021) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Redness of the legs; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness of the legs) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event and Back surgery.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced ERYTHEMA (Redness of the legs). At the time of the report, ERYTHEMA (Redness of the legs) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Hypoaesthesia oral, Urticaria, Vaccination site erythema
Clinical narrative: warm to the touch to my injection site; hives worse to my lower body but had them on my face and upper body as well; inflamed area that was warm to the touch to my injection site; large reddened at the injection site; lightheaded ness; A weird numb feeling in my mouth; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (lightheaded ness), HYPOAESTHESIA ORAL (A weird numb feeling in my mouth), VACCINATION SITE WARMTH (warm to the touch to my injection site), URTICARIA (hives worse to my lower body but had them on my face and upper body as well) and VACCINATION SITE INFLAMMATION (inflamed area that was warm to the touch to my injection site) in a female patient of an unknown age 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 Anaphylactic reaction (anaphylactic reaction to Macrobid 7-8 years ago.). Concurrent medical conditions included SLE. Concomitant products included METHYLPREDNISOLONE (MEDROL DOSEPAK) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced DIZZINESS (lightheaded ness) and HYPOAESTHESIA ORAL (A weird numb feeling in my mouth). On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (large reddened at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch to my injection site), URTICARIA (hives worse to my lower body but had them on my face and upper body as well) and VACCINATION SITE INFLAMMATION (inflamed area that was warm to the touch to my injection site). On 16-Jan-2021, VACCINATION SITE ERYTHEMA (large reddened at the injection site) had resolved. At the time of the report, DIZZINESS (lightheaded ness), HYPOAESTHESIA ORAL (A weird numb feeling in my mouth), VACCINATION SITE WARMTH (warm to the touch to my injection site) and VACCINATION SITE INFLAMMATION (inflamed area that was warm to the touch to my injection site) had resolved and URTICARIA (hives worse to my lower body but had them on my face and upper body as well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Heart rate: elevated Heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient do have an EpiPen. Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site warmth
Clinical narrative: warm to the touch to my injection site; hives worse to my lower body but had them on my face and upper body as well; inflamed area that was warm to the touch to my injection site; large reddened at the injection site; lightheaded ness; A weird numb feeling in my mouth; This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (lightheaded ness), HYPOAESTHESIA ORAL (A weird numb feeling in my mouth), VACCINATION SITE WARMTH (warm to the touch to my injection site), URTICARIA (hives worse to my lower body but had them on my face and upper body as well) and VACCINATION SITE INFLAMMATION (inflamed area that was warm to the touch to my injection site) in a female patient of an unknown age 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 Anaphylactic reaction (anaphylactic reaction to Macrobid 7-8 years ago.). Concurrent medical conditions included SLE. Concomitant products included METHYLPREDNISOLONE (MEDROL DOSEPAK) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced DIZZINESS (lightheaded ness) and HYPOAESTHESIA ORAL (A weird numb feeling in my mouth). On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (large reddened at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch to my injection site), URTICARIA (hives worse to my lower body but had them on my face and upper body as well) and VACCINATION SITE INFLAMMATION (inflamed area that was warm to the touch to my injection site). On 16-Jan-2021, VACCINATION SITE ERYTHEMA (large reddened at the injection site) had resolved. At the time of the report, DIZZINESS (lightheaded ness), HYPOAESTHESIA ORAL (A weird numb feeling in my mouth), VACCINATION SITE WARMTH (warm to the touch to my injection site) and VACCINATION SITE INFLAMMATION (inflamed area that was warm to the touch to my injection site) had resolved and URTICARIA (hives worse to my lower body but had them on my face and upper body as well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Heart rate: elevated Heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient do have an EpiPen. Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Feels like I got the flu; Just don't feel good; Running a temperature; Arm been really, really sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like I got the flu), PAIN IN EXTREMITY (Arm been really, really sore), FEELING ABNORMAL (Just don't feel good) and PYREXIA (Running a temperature) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm been really, really sore) and PYREXIA (Running a temperature). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Feels like I got the flu) and FEELING ABNORMAL (Just don't feel good). At the time of the report, INFLUENZA LIKE ILLNESS (Feels like I got the flu), FEELING ABNORMAL (Just don't feel good) and PYREXIA (Running a temperature) outcome was unknown and PAIN IN EXTREMITY (Arm been really, really sore) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: At 4:30 am 97.7 F and at 6:10 am 98.0 F. In February 2021, Body temperature: On unknown date body temperature was 99.1 F and 100 F.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue
Clinical narrative: Diarrhea; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHILLS (Chills) and FATIGUE (Fatigue) in a 90-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. Concomitant products included METFORMIN, Glypicide, LISINOPRIL, CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT), CALCIUM, DENOSUMAB (PROLIA) and WARFARIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Diarrhea), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test normal, Maternal exposure during pregnancy
Clinical narrative: Pregnant and want to be apart of pregnancy registry; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and want to be apart of pregnancy registry) in a female patient of an unknown age (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (3 Live full time births). Concurrent medical conditions included Eclampsia, antepartum and Heartburn. Concomitant products included OMEPRAZOLE for Heartburn, ACETYLSALICYLIC ACID (ASPIRIN 81) for Pre-eclampsia, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and want to be apart of pregnancy registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and want to be apart of pregnancy registry) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Glucose tolerance test normal: normal (normal) Normal.     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 medications were not reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Pruritus, Rash, Urticaria
Clinical narrative: rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it; rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it; but hives are there for the most time; rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), ECZEMA (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), URTICARIA (but hives are there for the most time) and RASH (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), ECZEMA (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), URTICARIA (but hives are there for the most time) and RASH (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at a dose of UNK dosage form. At the time of the report, PRURITUS (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), ECZEMA (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it), URTICARIA (but hives are there for the most time) and RASH (rash on his body that is still there and is itchy, sometimes with bumps, sometimes no bumps, it) 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Pain in extremity, Peripheral swelling, Vaccination site warmth
Clinical narrative: warm in arm; delayed red circle about the size of baseball; Initial redness; Swollen arm; minor arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm in arm), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (minor arm pain), ERYTHEMA (delayed red circle about the size of baseball) and INJECTION SITE ERYTHEMA (Initial redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroiditis (Hashimoto Thyroiditis), Migraine headache since 1964, High cholesterol, Vitiligo in 1962, Dairy intolerance (Dairy sensitivity) since 2006 and Osteopenia. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, CALCIUM, COLECALCIFEROL (CALCIUM PLUS D3) for Osteopenia, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroiditis, MULTIVITAMIN [VITAMINS NOS], ASCORBIC ACID (VIT C), TOCOPHEROL (VIT E [TOCOPHEROL]), FISH OIL and MACROGOL 3350 (MIRALAX) for an unknown indication.    On 16-Feb-2021 at 10:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (minor arm pain) and INJECTION SITE ERYTHEMA (Initial redness). On 26-Feb-2021, the patient experienced ERYTHEMA (delayed red circle about the size of baseball). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm in arm). On 18-Feb-2021, PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (minor arm pain) and INJECTION SITE ERYTHEMA (Initial redness) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm in arm) and ERYTHEMA (delayed red circle about the size of baseball) 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 treatment was reported.   This case was linked to MOD-2021-265652 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: significant follow up appended on 25-Jul-2021 and added event
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain, Peripheral swelling
Clinical narrative: I had an angry red patch at the injection site; Mark appeared that's 2 inches in diameter and is getting larger; Arm was swollen; Sore arm; Itching all throughout the body; Nausea; Achiness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (I had an angry red patch at the injection site), NAUSEA (Nausea), MYALGIA (Achiness), HEADACHE (Headache) and RASH (Mark appeared that's 2 inches in diameter and is getting larger) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol (Takes a cholesterol medicine.). Concurrent medical conditions included Allergy (allergic to mosquito bites). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Achiness), HEADACHE (Headache), PRURITUS (Itching all throughout the body) and PAIN (Sore arm). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (I had an angry red patch at the injection site), RASH (Mark appeared that's 2 inches in diameter and is getting larger) and PERIPHERAL SWELLING (Arm was swollen). At the time of the report, VACCINATION SITE ERYTHEMA (I had an angry red patch at the injection site), NAUSEA (Nausea), MYALGIA (Achiness), HEADACHE (Headache), RASH (Mark appeared that's 2 inches in diameter and is getting larger), PRURITUS (Itching all throughout the body), PERIPHERAL SWELLING (Arm was swollen) and PAIN (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treated with clobetasol cream 0.5mg applied for infected area.   This case was linked to MOD-2021-038402 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up on 21 Apr 2021 12.50 Pm: added medical history- allergic to mosquito bites and cholesterol , updated products tab- 2nd dose information, added concomitant drugs- Synthroid & a cholesterol medicine, the generic for Crestor as daily maintenance medications and added events of  07Feb2021: Her arm was swollen, & she had an angry red patch at the injection site. On 21-Apr-2021: Follow up on 21 Apr 2021 2.15pm: Events are still ongoing On 30-Apr-2021: Non-Significant follow up
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site erythema
Clinical narrative: I had an angry red patch at the injection site; Mark appeared that's 2 inches in diameter and is getting larger; Arm was swollen; Sore arm; Itching all throughout the body; Nausea; Achiness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (I had an angry red patch at the injection site), NAUSEA (Nausea), MYALGIA (Achiness), HEADACHE (Headache) and RASH (Mark appeared that's 2 inches in diameter and is getting larger) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol (Takes a cholesterol medicine.). Concurrent medical conditions included Allergy (allergic to mosquito bites). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Achiness), HEADACHE (Headache), PRURITUS (Itching all throughout the body) and PAIN (Sore arm). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (I had an angry red patch at the injection site), RASH (Mark appeared that's 2 inches in diameter and is getting larger) and PERIPHERAL SWELLING (Arm was swollen). At the time of the report, VACCINATION SITE ERYTHEMA (I had an angry red patch at the injection site), NAUSEA (Nausea), MYALGIA (Achiness), HEADACHE (Headache), RASH (Mark appeared that's 2 inches in diameter and is getting larger), PRURITUS (Itching all throughout the body), PERIPHERAL SWELLING (Arm was swollen) and PAIN (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treated with clobetasol cream 0.5mg applied for infected area.   This case was linked to MOD-2021-038402 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up on 21 Apr 2021 12.50 Pm: added medical history- allergic to mosquito bites and cholesterol , updated products tab- 2nd dose information, added concomitant drugs- Synthroid & a cholesterol medicine, the generic for Crestor as daily maintenance medications and added events of  07Feb2021: Her arm was swollen, & she had an angry red patch at the injection site. On 21-Apr-2021: Follow up on 21 Apr 2021 2.15pm: Events are still ongoing On 30-Apr-2021: Non-Significant follow up
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling abnormal, Lymphadenopathy, Malaise
Clinical narrative: Nausea; Vomiting; Lymph node pain and swelling; Back pain; Felt pretty sick; Felt terrible; Rash in her face that started in the upper lip; Fever; Shivering; Crumping behind the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Crumping behind the neck), BACK PAIN (Back pain), MALAISE (Felt pretty sick), FEELING ABNORMAL (Felt terrible) and RASH (Rash in her face that started in the upper lip) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Controlled), High cholesterol (Controlled), Breast cancer, Penicillin allergy, Drug allergy (Nucynta, Keflex, Cipro, Morphine, Citroen, Cephalexin, Sulfametho.) and Sulfonamide allergy. Concomitant products included TRANEXAMIC ACID (NEXIM) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE and CARVEDILOL for Blood pressure management, ROSUVASTATIN CALCIUM (CRESTOR) and EZETIMIBE (ZETIA) for Cholesterol, SIMVASTATIN for High cholesterol.   On 28-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 11:37 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced MUSCLE SPASMS (Crumping behind the neck). On 25-Feb-2021, the patient experienced BACK PAIN (Back pain), MALAISE (Felt pretty sick), FEELING ABNORMAL (Felt terrible), RASH (Rash in her face that started in the upper lip), PYREXIA (Fever) and CHILLS (Shivering). On 26-Feb-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and LYMPHADENOPATHY (Lymph node pain and swelling). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of UNK dosage form and ALPRAZOLAM (XANAX) for Adverse event, at a dose of UNK dosage form. On 26-Feb-2021, MUSCLE SPASMS (Crumping behind the neck), BACK PAIN (Back pain), MALAISE (Felt pretty sick), FEELING ABNORMAL (Felt terrible), PYREXIA (Fever) and CHILLS (Shivering) had resolved. On 03-Mar-2021, RASH (Rash in her face that started in the upper lip) had resolved. On 12-Mar-2021, LYMPHADENOPATHY (Lymph node pain and swelling) had resolved. At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Patient confirmed that she was not pregnant. On 09-May-2021: Medically confirm changed, Allergies, Concomitant medication and patient race added, Change in outcome of events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nausea, Pyrexia, Rash, Vomiting
Clinical narrative: Nausea; Vomiting; Lymph node pain and swelling; Back pain; Felt pretty sick; Felt terrible; Rash in her face that started in the upper lip; Fever; Shivering; Crumping behind the neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Crumping behind the neck), BACK PAIN (Back pain), MALAISE (Felt pretty sick), FEELING ABNORMAL (Felt terrible) and RASH (Rash in her face that started in the upper lip) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Controlled), High cholesterol (Controlled), Breast cancer, Penicillin allergy, Drug allergy (Nucynta, Keflex, Cipro, Morphine, Citroen, Cephalexin, Sulfametho.) and Sulfonamide allergy. Concomitant products included TRANEXAMIC ACID (NEXIM) for Acid reflux (oesophageal), HYDROCHLOROTHIAZIDE and CARVEDILOL for Blood pressure management, ROSUVASTATIN CALCIUM (CRESTOR) and EZETIMIBE (ZETIA) for Cholesterol, SIMVASTATIN for High cholesterol.   On 28-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021 at 11:37 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced MUSCLE SPASMS (Crumping behind the neck). On 25-Feb-2021, the patient experienced BACK PAIN (Back pain), MALAISE (Felt pretty sick), FEELING ABNORMAL (Felt terrible), RASH (Rash in her face that started in the upper lip), PYREXIA (Fever) and CHILLS (Shivering). On 26-Feb-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting) and LYMPHADENOPATHY (Lymph node pain and swelling). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of UNK dosage form and ALPRAZOLAM (XANAX) for Adverse event, at a dose of UNK dosage form. On 26-Feb-2021, MUSCLE SPASMS (Crumping behind the neck), BACK PAIN (Back pain), MALAISE (Felt pretty sick), FEELING ABNORMAL (Felt terrible), PYREXIA (Fever) and CHILLS (Shivering) had resolved. On 03-Mar-2021, RASH (Rash in her face that started in the upper lip) had resolved. On 12-Mar-2021, LYMPHADENOPATHY (Lymph node pain and swelling) had resolved. At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Patient confirmed that she was not pregnant. On 09-May-2021: Medically confirm changed, Allergies, Concomitant medication and patient race added, Change in outcome of events.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasopharyngitis, Vaccination site pain
Clinical narrative: Cold; Headache; Soreness at injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), HEADACHE (Headache), VACCINATION SITE PAIN (Soreness at injection site) and FATIGUE (Tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy since an unknown date. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced NASOPHARYNGITIS (Cold), HEADACHE (Headache), VACCINATION SITE PAIN (Soreness at injection site) and FATIGUE (Tired). At the time of the report, NASOPHARYNGITIS (Cold), HEADACHE (Headache), VACCINATION SITE PAIN (Soreness at injection site) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (Shortness of breath) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound testes
Clinical narrative: Exposure during preganacy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Exposure during preganacy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (Spontaneous abortion).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-May-2021. On 27-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Exposure during preganacy). On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Exposure during preganacy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2020, Pregnancy test: positive (Positive) Positive. On 16-Sep-2020, Ultrasound testes: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 37 year old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Feeling cold, Headache
Clinical narrative: feeling very cold the morning after the vaccination; loss of appetite; Diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling very cold the morning after the vaccination), DECREASED APPETITE (loss of appetite), DIARRHOEA (Diarrhea) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     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 27-Feb-2021, the patient experienced FEELING COLD (feeling very cold the morning after the vaccination), DECREASED APPETITE (loss of appetite), DIARRHOEA (Diarrhea) and HEADACHE (headache). At the time of the report, FEELING COLD (feeling very cold the morning after the vaccination), DECREASED APPETITE (loss of appetite) and HEADACHE (headache) had resolved and DIARRHOEA (Diarrhea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.  Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pruritus, Interchange of vaccine products, Product dose omission issue, Throat irritation
Clinical narrative: received the Johnson & Johnson COVID-19 vaccine; Patient 2nd Dose past 42 days; itchy throat; itching in eustachian tubes; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient 2nd Dose past 42 days), THROAT IRRITATION (itchy throat), EAR PRURITUS (itching in eustachian tubes) and INTERCHANGE OF VACCINE PRODUCTS (received the Johnson & Johnson COVID-19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (40 years earlier).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced THROAT IRRITATION (itchy throat) and EAR PRURITUS (itching in eustachian tubes). On 08-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient 2nd Dose past 42 days). On 03-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received the Johnson & Johnson COVID-19 vaccine). On 11-Jan-2021, THROAT IRRITATION (itchy throat) and EAR PRURITUS (itching in eustachian tubes) had resolved. On 08-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Patient 2nd Dose past 42 days) had resolved. On 03-May-2021, INTERCHANGE OF VACCINE PRODUCTS (received the Johnson & Johnson COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported.  No treatment information was provided.     This case was linked to.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Patient received another manufacturer's vaccine after Moderna vaccine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The causality for the event of missed dose is assessed as not applicable.