chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: rash/redness in left arm extending past injection site; reaction in her arm; discomfort just as the day after receiving the vaccine; Pain radiating from left shoulder, upper back to right shoulder; Swelling at left shoulder area near neck; Redness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction in her arm), VACCINATION SITE DISCOMFORT (discomfort just as the day after receiving the vaccine), PAIN (Pain radiating from left shoulder, upper back to right shoulder), SWELLING (Swelling at left shoulder area near neck) and ERYTHEMA (Redness in arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for Blood pressure, CENTRUM SILVER [ASCORBIC ACID;BIOTIN;BORON;CALCIUM;CALCIUM PANTOTHENATE;CHLORINE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCH for Supplementation therapy, LEVOTHYROXINE for Thyroidectomy partial, CALCIUM (ALGAE CALCIUM) and MONASCUS PURPUREUS (RED YEAST RICE) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE REACTION (reaction in her arm), VACCINATION SITE DISCOMFORT (discomfort just as the day after receiving the vaccine), PAIN (Pain radiating from left shoulder, upper back to right shoulder), SWELLING (Swelling at left shoulder area near neck) and ERYTHEMA (Redness in arm). On an unknown date, the patient experienced VACCINATION SITE RASH (rash/redness in left arm extending past injection site). At the time of the report, VACCINATION SITE REACTION (reaction in her arm), VACCINATION SITE DISCOMFORT (discomfort just as the day after receiving the vaccine), PAIN (Pain radiating from left shoulder, upper back to right shoulder), ERYTHEMA (Redness in arm) and VACCINATION SITE RASH (rash/redness in left arm extending past injection site) had resolved and SWELLING (Swelling at left shoulder area near neck) had not resolved. Not Provided          Concomitant medications Algal cal plus indicated for Bone strength & Red yeast rice with Coq indicated for cardio health. It was reported that patient was advised to take Tylenol   This case was linked to MOD-2021-245531 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Updated patient address and email ID On 23-Jun-2021: F/U- 2 : Patient demographics, medical history, dose 2 details and concomitant medication list were added. And adverse event details and outcome are updated.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: starting to itch; Minor pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (starting to itch) and VACCINATION SITE PAIN (Minor pain at the injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Minor pain at the injection site). On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (starting to itch). At the time of the report, VACCINATION SITE PRURITUS (starting to itch) and VACCINATION SITE PAIN (Minor pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Hypoaesthesia, Nerve conduction studies abnormal, Pain
Clinical narrative: Slowed reaction in nerve conduction on that arm; Numbness in different parts of the body; Pain on one part of my body; Numbness in right lower arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in right lower arm), HYPOAESTHESIA (Numbness in different parts of the body), PAIN (Pain on one part of my body) and NERVE CONDUCTION STUDIES ABNORMAL (Slowed reaction in nerve conduction on that arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporetr.     On 02-Nov-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 22-Nov-2020, the patient experienced HYPOAESTHESIA (Numbness in right lower arm). On 20-Dec-2020, the patient experienced HYPOAESTHESIA (Numbness in different parts of the body) and PAIN (Pain on one part of my body). On an unknown date, the patient experienced NERVE CONDUCTION STUDIES ABNORMAL (Slowed reaction in nerve conduction on that arm). At the time of the report, HYPOAESTHESIA (Numbness in right lower arm), HYPOAESTHESIA (Numbness in different parts of the body), PAIN (Pain on one part of my body) and NERVE CONDUCTION STUDIES ABNORMAL (Slowed reaction in nerve conduction on that arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: 180 (abnormal) The blood work done and came back normal except for ANA reports that came back 180..
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness; swelling; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012l20a) for COVID-19 vaccination.     No medical history was provided by  the reporter.     On 13-Jan-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 VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling). On 29-Jan-2021, VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling) 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm itching; Sore arm, tenderness; Arm redness; Arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE PAIN (Sore arm, tenderness), VACCINATION SITE ERYTHEMA (Arm redness) and VACCINATION SITE SWELLING (Arm swelling) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K202A and 032B21A) for COVID-19 vaccination.   The patient's past medical history included Chronic sinusitis in 2000. Concurrent medical conditions included Drug allergy (Astelyn nasal spray). Concomitant products included CALCIUM for Supplementation therapy, AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) for Tooth ache, VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]), VITAMIN D [VITAMIN D NOS], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE PAIN (Sore arm, tenderness), VACCINATION SITE ERYTHEMA (Arm redness) and VACCINATION SITE SWELLING (Arm swelling). The patient was treated with HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) (topical) for Itch, at a dose of cream. At the time of the report, VACCINATION SITE PRURITUS (Arm itching), VACCINATION SITE PAIN (Sore arm, tenderness), VACCINATION SITE ERYTHEMA (Arm redness) and VACCINATION SITE SWELLING (Arm swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include MVI   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received addition of relevant history ,addition of patient demography, addition of concomitant medications, addition of second Moderna dose vaccine; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Vaccination site rash; rash little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PAIN (rash little sore) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L209) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALOGLIPTIN, AMLODIPINE, CHOLECALCIFEROL, CLOTRIMAZOLE, DUPILUMAB (DUPIXENT), LOSARTAN, METFORMIN, MULTVITAMIN & MINERAL, OMEPRAZOLE, ROSUVASTATIN and INSULIN for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PAIN (rash little sore). At the time of the report, VACCINATION SITE RASH (Vaccination site rash) was resolving and VACCINATION SITE PAIN (rash little sore) had not 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.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Raynaud's phenomenon
Clinical narrative: Raynaud's phenomenon; This spontaneous case was reported by a physician and describes the occurrence of RAYNAUD'S PHENOMENON (Raynaud's phenomenon) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RAYNAUD'S PHENOMENON (Raynaud's phenomenon). The patient was treated with Physical therapy (Rewarming the limb) for Raynaud's phenomenon. At the time of the report, RAYNAUD'S PHENOMENON (Raynaud's phenomenon) had not 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.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Added patient contact details, Patient demographics. and Route of administration details.  Updated treatment details.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Acquired COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Acquired COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 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 COVID-19 (Acquired COVID-19). At the time of the report, COVID-19 (Acquired COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Diarrhoea, Fatigue, Feeling cold, Migraine
Clinical narrative: Explosive diarrhea; Migraine; Mild diarrhea; Feeling really tired; Nausea; Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI; Tingling on lips; Buzzing or vibration all over body; Mild tachycardia; Slightly elevated blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia) and BLOOD PRESSURE INCREASED (Slightly elevated blood pressure) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Anxiety. Concomitant products included LORAZEPAM (ATIVAN), IBUPROFEN (ADVIL [IBUPROFEN]), VITAMINS NOS and ZINC for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia), BLOOD PRESSURE INCREASED (Slightly elevated blood pressure), FATIGUE (Feeling really tired) and NAUSEA (Nausea). On 20-Jan-2021, the patient experienced DIARRHOEA (Mild diarrhea). On 21-Jan-2021, the patient experienced MIGRAINE (Migraine). On 22-Jan-2021, the patient experienced DIARRHOEA (Explosive diarrhea). On 19-Jan-2021, FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia), BLOOD PRESSURE INCREASED (Slightly elevated blood pressure) and NAUSEA (Nausea) had resolved. On 20-Jan-2021, DIARRHOEA (Mild diarrhea) and FATIGUE (Feeling really tired) had resolved. On 21-Jan-2021, MIGRAINE (Migraine) had resolved. At the time of the report, DIARRHOEA (Explosive diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia oral, Sensory disturbance, Tachycardia
Clinical narrative: Explosive diarrhea; Migraine; Mild diarrhea; Feeling really tired; Nausea; Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI; Tingling on lips; Buzzing or vibration all over body; Mild tachycardia; Slightly elevated blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia) and BLOOD PRESSURE INCREASED (Slightly elevated blood pressure) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Anxiety. Concomitant products included LORAZEPAM (ATIVAN), IBUPROFEN (ADVIL [IBUPROFEN]), VITAMINS NOS and ZINC for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia), BLOOD PRESSURE INCREASED (Slightly elevated blood pressure), FATIGUE (Feeling really tired) and NAUSEA (Nausea). On 20-Jan-2021, the patient experienced DIARRHOEA (Mild diarrhea). On 21-Jan-2021, the patient experienced MIGRAINE (Migraine). On 22-Jan-2021, the patient experienced DIARRHOEA (Explosive diarrhea). On 19-Jan-2021, FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia), BLOOD PRESSURE INCREASED (Slightly elevated blood pressure) and NAUSEA (Nausea) had resolved. On 20-Jan-2021, DIARRHOEA (Mild diarrhea) and FATIGUE (Feeling really tired) had resolved. On 21-Jan-2021, MIGRAINE (Migraine) had resolved. At the time of the report, DIARRHOEA (Explosive diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (tiredness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (past medical history not provided). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), MONTELUKAST SODIUM, FINASTERIDE, CLOPIDOGREL and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEADACHE (Headache) and FATIGUE (tiredness). On 27-Jan-2021, HEADACHE (Headache) and FATIGUE (tiredness) 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.   Patient Feels back to Normal and is not worried about the Events No treatment information was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Contusion, Lymph node pain, Rash erythematous, Rash pruritic
Clinical narrative: Large swollen rash at injection site; Armpit pain; Pain in lymph nodes in neck and arm; Itchy rash; Red rash; Large swollen rash at injection site; Bruise; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (Large swollen rash at injection site), VACCINATION SITE RASH (Large swollen rash at injection site), AXILLARY PAIN (Armpit pain), CONTUSION (Bruise) and LYMPH NODE PAIN (Pain in lymph nodes in neck and arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy (Denies pregnancy, as she is on ortho tricyclin). Concomitant products included ARTEMISININ (TRICYCLINE) for Oral contraceptive.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced CONTUSION (Bruise). On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (Large swollen rash at injection site). On 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Large swollen rash at injection site), AXILLARY PAIN (Armpit pain), LYMPH NODE PAIN (Pain in lymph nodes in neck and arm), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash). At the time of the report, VACCINATION SITE SWELLING (Large swollen rash at injection site), VACCINATION SITE RASH (Large swollen rash at injection site), AXILLARY PAIN (Armpit pain), CONTUSION (Bruise), LYMPH NODE PAIN (Pain in lymph nodes in neck and arm), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medication included ortho tricyclin.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Large swollen rash at injection site; Armpit pain; Pain in lymph nodes in neck and arm; Itchy rash; Red rash; Large swollen rash at injection site; Bruise; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (Large swollen rash at injection site), VACCINATION SITE RASH (Large swollen rash at injection site), AXILLARY PAIN (Armpit pain), CONTUSION (Bruise) and LYMPH NODE PAIN (Pain in lymph nodes in neck and arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pregnancy (Denies pregnancy, as she is on ortho tricyclin). Concomitant products included ARTEMISININ (TRICYCLINE) for Oral contraceptive.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced CONTUSION (Bruise). On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (Large swollen rash at injection site). On 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Large swollen rash at injection site), AXILLARY PAIN (Armpit pain), LYMPH NODE PAIN (Pain in lymph nodes in neck and arm), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash). At the time of the report, VACCINATION SITE SWELLING (Large swollen rash at injection site), VACCINATION SITE RASH (Large swollen rash at injection site), AXILLARY PAIN (Armpit pain), CONTUSION (Bruise), LYMPH NODE PAIN (Pain in lymph nodes in neck and arm), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medication included ortho tricyclin.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later). At the time of the report, COVID-19 (Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Injection site cellulitis, Injection site erythema, Injection site haematoma
Clinical narrative: Heavy flushing coming over her; Lightheaded; Dizzy; General feeling of being unwell; The injection site was red; Injection site the size of a quarter; Injection site spread to the size of a coffee can lid; It looked bruised; She wondered if she had cellulitis; the lymph nodes in injection site were swollen; A Spontaneous report was received from  Non healthcare professional concerning a 59 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lightheaded, dizzy, fast heart rate of 80-90, The injection site was red, Injection site the size of a quarter, lymph nodes in injection site were swollen  The patient's medical history, as reported include Have had anaphylaxis shock with chemo allergic reactions.fibromyalgia - muscle ache every day, nausea, Diabetic. Low vit D and concomitant medications Cyclobenzaprine, Pioglitazone 30mg a day, Probiotic daily, Atorvastatin, Benadryl when needed, Colestipol two a day, Losartan potassium, Metformin 1000 two a day, Nebivolol at night, Vit D3, Tylenol or Aleve if needed.  On 14 JAN 2021, the patient received their one dose of the two planned doses of COVID-19 Vaccine (mRNA-1273) intramuscularly in the left arm for prophylaxis of COVID-19 infection and had a reaction to the first dose that thinks it maybe an allergic reaction. Within a couple of minutes, she felt like a heavy flushing coming over her. She stayed for 30 mins to get checked up and then went away. She also felt lightheaded and dizzy and had a fast heart rate of 80-90. She had a general feeling of being unwell. These went away in an hour, and she is used to feeling like that and nauseous. She usually has vertigo episodes The injection site was also red and the size of a quarter, but then it spread to the size of a coffee can lid. For the next 10 days it kept getting lighter, maybe because she is fair skinned, it looked bruised. She wondered if she had cellulitis. Also, the lymph nodes in injection site were swollen.   No treatment information is provided  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event is resolved/recovered
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy, Malaise, Vitamin D
Clinical narrative: Heavy flushing coming over her; Lightheaded; Dizzy; General feeling of being unwell; The injection site was red; Injection site the size of a quarter; Injection site spread to the size of a coffee can lid; It looked bruised; She wondered if she had cellulitis; the lymph nodes in injection site were swollen; A Spontaneous report was received from  Non healthcare professional concerning a 59 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lightheaded, dizzy, fast heart rate of 80-90, The injection site was red, Injection site the size of a quarter, lymph nodes in injection site were swollen  The patient's medical history, as reported include Have had anaphylaxis shock with chemo allergic reactions.fibromyalgia - muscle ache every day, nausea, Diabetic. Low vit D and concomitant medications Cyclobenzaprine, Pioglitazone 30mg a day, Probiotic daily, Atorvastatin, Benadryl when needed, Colestipol two a day, Losartan potassium, Metformin 1000 two a day, Nebivolol at night, Vit D3, Tylenol or Aleve if needed.  On 14 JAN 2021, the patient received their one dose of the two planned doses of COVID-19 Vaccine (mRNA-1273) intramuscularly in the left arm for prophylaxis of COVID-19 infection and had a reaction to the first dose that thinks it maybe an allergic reaction. Within a couple of minutes, she felt like a heavy flushing coming over her. She stayed for 30 mins to get checked up and then went away. She also felt lightheaded and dizzy and had a fast heart rate of 80-90. She had a general feeling of being unwell. These went away in an hour, and she is used to feeling like that and nauseous. She usually has vertigo episodes The injection site was also red and the size of a quarter, but then it spread to the size of a coffee can lid. For the next 10 days it kept getting lighter, maybe because she is fair skinned, it looked bruised. She wondered if she had cellulitis. Also, the lymph nodes in injection site were swollen.   No treatment information is provided  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event is resolved/recovered
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Myalgia
Clinical narrative: Pregnancy at time of Vaccination; Headache; Sore Arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy at time of Vaccination), MYALGIA (Sore Arm) and HEADACHE (Headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa). Concomitant products included FLUTICASONE from 01-Jan-2017 to an unknown date for Seasonal allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-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 27-Nov-2020 and the estimated date of delivery was 22-Sep-2021. On 28-Dec-2020, the patient experienced MYALGIA (Sore Arm). On 29-Dec-2020, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy at time of Vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 30-Dec-2020, MYALGIA (Sore Arm) and HEADACHE (Headache) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy at time of Vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication Prenatal vitamins, Fluticasone. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Added patient relevant history (Allergy) details, Concomitant medications
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Breast enlargement, Breast swelling, Chest pain, Computerised tomogram
Clinical narrative: lymph node enlargement; Left breat was heavier than right; If I press around the lining by the chest or sternum, it hurts; Sprain; Felt some swelling on the lining of the brest; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest). At the time of the report, LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: mmHg Inconclusive. On an unknown date, Computerised tomogram: negative Negative. On an unknown date, Electrocardiogram: Inconclusive. On an unknown date, Fibrin D dimer: high ng/mL (High) The D-Dimer was elevated which indicated a chance for DVT. On an unknown date, X-ray: (Inconclusive) The X-ray taken was unclear.     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 information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fibrin D dimer, Ligament sprain, Lymphadenopathy, X-ray
Clinical narrative: lymph node enlargement; Left breat was heavier than right; If I press around the lining by the chest or sternum, it hurts; Sprain; Felt some swelling on the lining of the brest; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest). At the time of the report, LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: mmHg Inconclusive. On an unknown date, Computerised tomogram: negative Negative. On an unknown date, Electrocardiogram: Inconclusive. On an unknown date, Fibrin D dimer: high ng/mL (High) The D-Dimer was elevated which indicated a chance for DVT. On an unknown date, X-ray: (Inconclusive) The X-ray taken was unclear.     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 information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oral discharge, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: woke up spitting up clear, thick mucous like liquid; chills; tingling down her leg like a blood clot; heart was racing; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORAL DISCHARGE (woke up spitting up clear, thick mucous like liquid), CHILLS (chills), PARAESTHESIA (tingling down her leg like a blood clot), PALPITATIONS (heart was racing) and PAIN IN EXTREMITY (sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thrombosis since an unknown date and Vertigo since an unknown date. Concomitant products included WARFARIN SODIUM (COUMADIN), LORATADINE (LORATADIN) and OXYCODONE HYDROCHLORIDE (OXYCONTIN) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Jan-2021, the patient experienced ORAL DISCHARGE (woke up spitting up clear, thick mucous like liquid), CHILLS (chills), PARAESTHESIA (tingling down her leg like a blood clot), PALPITATIONS (heart was racing) and PAIN IN EXTREMITY (sore arm). At the time of the report, ORAL DISCHARGE (woke up spitting up clear, thick mucous like liquid), CHILLS (chills), PARAESTHESIA (tingling down her leg like a blood clot), PALPITATIONS (heart was racing) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy from January 2017 to 04-Oct-2017. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 08-Feb-2021 to an unknown date for an unknown indication.    On 09-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 21-Dec-2020 and the estimated date of delivery was 27-Sep-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventh week of the pregnancy.  On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Pregnancy test: positive (Positive) positive.     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 information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: very swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (very swollen arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (very swollen arm). At the time of the report, PERIPHERAL SWELLING (very swollen arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Bronchitis, Influenza, SARS-CoV-2 test
Clinical narrative: Bronchitis; flu; lost taste; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), INFLUENZA (flu) and AGEUSIA (lost taste) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced BRONCHITIS (Bronchitis), INFLUENZA (flu) and AGEUSIA (lost taste). At the time of the report, BRONCHITIS (Bronchitis), INFLUENZA (flu) and AGEUSIA (lost taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gestational diabetes, Headache, Maternal exposure during pregnancy
Clinical narrative: The patient's past medical history included Melanoma in August 2015 and Alcohol abuse (1 drink every couple of months) from 2021 to 2020. Concurrent medical conditions included Pregnant since 20-Sep-2020. Concomitant products included PYRIDOXINE HYDROCHLORIDE (B6) and DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) for Nausea, CHORIOGONADOTROPIN ALFA (OVIDREL [CHORIOGONADOTROPIN ALFA]) from 19-Sep-2020 to an unknown date and LETROZOLE from 07-Sep-2020 to 11-Sep-2020 for Subfertility, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FOLIC ACID (FOLIC) and IRON for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-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 03-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 28-Jan-2021, the patient experienced FATIGUE (fatigue), ARTHRALGIA (arthralgia), MYALGIA (myalgia) and HEADACHE (headache). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Jan-2021, FATIGUE (fatigue), ARTHRALGIA (arthralgia), MYALGIA (myalgia) and HEADACHE (headache) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2020, Gestational diabetes:. On 17-Dec-2020, Prenatal screening test: normal (normal) normal. On 26-Jan-2021, Ultrasound uterus: normal (normal) 20 week ultrasound normal.. On 24-Feb-2021, Gestational diabetes: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication Tylenol   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Updated Patient demographics, LMP, Delivery due date.Added lab data (NIPT,1-h-OGTT), Medical history (Melanoma).Added sub-fertility drugs(Ovidrel and Letrozole).Updated route of administration and start date  for all concomitants, stop date and indication for both B6 and unisom medications.Added patient info (prior alcohol use).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Prenatal screening test, Ultrasound uterus
Clinical narrative: The patient's past medical history included Melanoma in August 2015 and Alcohol abuse (1 drink every couple of months) from 2021 to 2020. Concurrent medical conditions included Pregnant since 20-Sep-2020. Concomitant products included PYRIDOXINE HYDROCHLORIDE (B6) and DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) for Nausea, CHORIOGONADOTROPIN ALFA (OVIDREL [CHORIOGONADOTROPIN ALFA]) from 19-Sep-2020 to an unknown date and LETROZOLE from 07-Sep-2020 to 11-Sep-2020 for Subfertility, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FOLIC ACID (FOLIC) and IRON for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-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 03-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 28-Jan-2021, the patient experienced FATIGUE (fatigue), ARTHRALGIA (arthralgia), MYALGIA (myalgia) and HEADACHE (headache). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Jan-2021, FATIGUE (fatigue), ARTHRALGIA (arthralgia), MYALGIA (myalgia) and HEADACHE (headache) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2020, Gestational diabetes:. On 17-Dec-2020, Prenatal screening test: normal (normal) normal. On 26-Jan-2021, Ultrasound uterus: normal (normal) 20 week ultrasound normal.. On 24-Feb-2021, Gestational diabetes: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication Tylenol   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Updated Patient demographics, LMP, Delivery due date.Added lab data (NIPT,1-h-OGTT), Medical history (Melanoma).Added sub-fertility drugs(Ovidrel and Letrozole).Updated route of administration and start date  for all concomitants, stop date and indication for both B6 and unisom medications.Added patient info (prior alcohol use).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive, Sinus congestion, Sneezing
Clinical narrative: really bad headache; some sinus congestion; sneezing; Tested positive for COVID 19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HEADACHE (really bad headache) and COVID-19 (Tested positive for COVID 19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included RA. Concomitant products included TOFACITINIB CITRATE (XELJANZ) for Rheumatoid arthritis.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID 19). On an unknown date, the patient experienced HEADACHE (really bad headache). At the time of the report, HEADACHE (really bad headache) and COVID-19 (Tested positive for COVID 19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test positive: positive Positive.     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 information was provided.  No concomitant medication was provided.