chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a slight headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, METOPROLOL, MONTELUKAST and LOSARTAN for an unknown indication.   On 12-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 12-Mar-2021, the patient experienced HEADACHE (a slight headache). On 12-Mar-2021, HEADACHE (a slight headache) had resolved.            Asthma Inhaler used as a Concomitant medication.  Tylenol used as a Treatment Medication. Action taken with mRNA-1273 in response to the event was not applicable.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Fatigue, Headache, Myalgia
Clinical narrative: shortness of breath on exertion; diarrhea; body aches; muscle ache; rash at the injection site; felt tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache) and VACCINATION SITE RASH (rash at the injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (Type-2 diabetes).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache), VACCINATION SITE RASH (rash at the injection site), FATIGUE (felt tired) and HEADACHE (headache). At the time of the report, DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache), VACCINATION SITE RASH (rash at the injection site), FATIGUE (felt tired) and HEADACHE (headache) outcome was unknown.            the action taken with response to drug is not applicable
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site rash
Clinical narrative: shortness of breath on exertion; diarrhea; body aches; muscle ache; rash at the injection site; felt tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache) and VACCINATION SITE RASH (rash at the injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (Type-2 diabetes).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache), VACCINATION SITE RASH (rash at the injection site), FATIGUE (felt tired) and HEADACHE (headache). At the time of the report, DYSPNOEA (shortness of breath on exertion), DIARRHOEA (diarrhea), PAIN (body aches), MYALGIA (muscle ache), VACCINATION SITE RASH (rash at the injection site), FATIGUE (felt tired) and HEADACHE (headache) outcome was unknown.            the action taken with response to drug is not applicable
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: still kind of hot felt hot; red spot (injection site); little swollen; very very itching/felt like scratching around the area; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (still kind of hot felt hot), VACCINATION SITE ERYTHEMA (red spot (injection site)), VACCINATION SITE SWELLING (little swollen) and VACCINATION SITE PRURITUS (very very itching/felt like scratching around the area) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING HOT (still kind of hot felt hot), VACCINATION SITE ERYTHEMA (red spot (injection site)), VACCINATION SITE SWELLING (little swollen) and VACCINATION SITE PRURITUS (very very itching/felt like scratching around the area). At the time of the report, FEELING HOT (still kind of hot felt hot), VACCINATION SITE ERYTHEMA (red spot (injection site)) and VACCINATION SITE SWELLING (little swollen) had not resolved and VACCINATION SITE PRURITUS (very very itching/felt like scratching around the area) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other medications include high blood pressure medicine. Treatment information not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pelvic pain
Clinical narrative: Pain in the lower pelvic area; Fatigue; Pain on right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on right arm), PELVIC PAIN (Pain in the lower pelvic area) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lymph node disorder.   On 12-Mar-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 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain on right arm) and FATIGUE (Fatigue). On 17-Mar-2021, the patient experienced PELVIC PAIN (Pain in the lower pelvic area). On 13-Mar-2021, PAIN IN EXTREMITY (Pain on right arm) and FATIGUE (Fatigue) had resolved. At the time of the report, PELVIC PAIN (Pain in the lower pelvic area) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant product use was not provided by the reporter.  No treatment information were reported. .
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: Arm Pain - Near Injection Site; Swelling - Near Injection Site; Redness - Near Injection Site; Rash - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Diabetes. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Cholesterol, METFORMIN and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site). The patient was treated with IBUPROFEN ongoing from 06-Mar-2021 for Pain management, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm Pain - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) 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.   Other concomitant medication included thyroid medication. ibuprofen is used as treatment medication.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Tremor
Clinical narrative: Chills/shakes; Chills/shakes; A mild fever at 100F; Tenderness at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache). At the time of the report, TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 100 (High) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication was not given.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills/shakes; Chills/shakes; A mild fever at 100F; Tenderness at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache). At the time of the report, TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 100 (High) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication was not given.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: Sleeplessness night; itchy area at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplessness night) and PRURITUS (itchy area at injection site) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Sleeplessness night) and PRURITUS (itchy area at injection site). At the time of the report, INSOMNIA (Sleeplessness night) and PRURITUS (itchy area at injection site) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment information was not provided.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose 6 days after first dose; A spontaneous report was received from other health care professional concerning a 44-years-old, female patient who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) 6 days after first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 012A21A) on right arm for prophylaxis of COVID-19 infection. On 18 Mar 2021, 6 days after vaccination, the patient received their second dose of mRNA-1273 (Batch Number: 029A21A) on left arm for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient received second dose 6 days after first dose.  No treatment information was provided.  The patient received both the doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   The outcome of the event, patient received second dose 6 days after first dose was considered as resolved on 18 Mar 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 029A21A for second dose) with no associated AEs reported.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (cold). At the time of the report, NASOPHARYNGITIS (cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No  concomitant medications were provided. No Treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dysphonia, Illness, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Throat still sounds froggy), ILLNESS (Sound slightly sick), COUGH (bit of a cough), URTICARIA (breaking out in hives) and RASH (rash all over her body) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for an unknown indication.   On 15-Mar-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 16-Mar-2021, the patient experienced COUGH (bit of a cough), CHILLS (Chills) and PYREXIA (fever). On 17-Mar-2021, the patient experienced URTICARIA (breaking out in hives) and RASH (rash all over her body). On 18-Mar-2021, the patient experienced DYSPHONIA (Throat still sounds froggy) and ILLNESS (Sound slightly sick). At the time of the report, DYSPHONIA (Throat still sounds froggy), ILLNESS (Sound slightly sick), COUGH (bit of a cough), URTICARIA (breaking out in hives), RASH (rash all over her body), CHILLS (Chills) and PYREXIA (fever) had not resolved.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Throat still sounds froggy), ILLNESS (Sound slightly sick), COUGH (bit of a cough), URTICARIA (breaking out in hives) and RASH (rash all over her body) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for an unknown indication.   On 15-Mar-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 16-Mar-2021, the patient experienced COUGH (bit of a cough), CHILLS (Chills) and PYREXIA (fever). On 17-Mar-2021, the patient experienced URTICARIA (breaking out in hives) and RASH (rash all over her body). On 18-Mar-2021, the patient experienced DYSPHONIA (Throat still sounds froggy) and ILLNESS (Sound slightly sick). At the time of the report, DYSPHONIA (Throat still sounds froggy), ILLNESS (Sound slightly sick), COUGH (bit of a cough), URTICARIA (breaking out in hives), RASH (rash all over her body), CHILLS (Chills) and PYREXIA (fever) had not resolved.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included INSULIN and METFORMIN for Diabetes, WARFARIN for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant medication includes blood pressure pills. treatment information not provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: red; itchy; sensitive; rash at the injection site; a little bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red), RASH PRURITIC (itchy), VACCINATION SITE PAIN (sensitive), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red), RASH PRURITIC (itchy), VACCINATION SITE PAIN (sensitive), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit swollen). At the time of the report, RASH ERYTHEMATOUS (red), RASH PRURITIC (itchy), VACCINATION SITE PAIN (sensitive), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Tenderness, Vaccination site induration
Clinical narrative: left arm is itchy; red spot bigger than a golf ball; barely tender; hard knot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (left arm is itchy), ERYTHEMA (red spot bigger than a golf ball), TENDERNESS (barely tender) and VACCINATION SITE INDURATION (hard knot at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (left arm is itchy), ERYTHEMA (red spot bigger than a golf ball), TENDERNESS (barely tender) and VACCINATION SITE INDURATION (hard knot at injection site). At the time of the report, PRURITUS (left arm is itchy), ERYTHEMA (red spot bigger than a golf ball), TENDERNESS (barely tender) and VACCINATION SITE INDURATION (hard knot at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity
Clinical narrative: Bruise after receiving 1st dose; sore left arm after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise after receiving 1st dose) and PAIN IN EXTREMITY (sore left arm after receiving 1st dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Feb-2021, the patient experienced CONTUSION (Bruise after receiving 1st dose) and PAIN IN EXTREMITY (sore left arm after receiving 1st dose). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 27-Feb-2021, CONTUSION (Bruise after receiving 1st dose) and PAIN IN EXTREMITY (sore left arm after receiving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness
Clinical narrative: Dizziness; Chest pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Mar-2021 and was forwarded to Moderna on 18-Mar-2021.    This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Dizziness) and CHEST PAIN (Chest pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (trees and grass) and Food allergy (fruits, lemons, melons, certain spices such as coriander, thyme, and pepper). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness) and CHEST PAIN (Chest pain). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Dizziness and Chest pain, at a dose of 1 dosage form. On 22-Feb-2021, DIZZINESS (Dizziness) and CHEST PAIN (Chest pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. The patient's last menstrual period was on 08-Jan-2021 and the estimated date of delivery was 15-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown. Not Provided          Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Alcohol use (socially - 3 drinks per week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 14-Feb-2021 to an unknown date for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 16-Jan-2021 and the estimated date of delivery was 23-Oct-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Pregnancy test: positive (Positive) positive. On 14-Apr-2021, Glucose tolerance test: april 12, 2021: negative (within normal range) (normal) April 12, 2021: negative (within normal range).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Estimated date of conception on 30 Jan 2021 In Apr 2021, MaterniT21 PLUS Core+ESS+SCA was performed resulted in to April 12, 2021: negative screenings for chromosomal disorders (Trisomy 23, 18, 13). On 14 May 2021, AFP was performed and resulted into May 07, 2021: Screen Negative for Open Spina Bifida.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: completed Pregnancy Report Form.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Fever; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and ARTHRALGIA (Shoulder pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (Fever) and ARTHRALGIA (Shoulder pain). At the time of the report, PYREXIA (Fever) and ARTHRALGIA (Shoulder pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: shortness of breath; sweating more than normal; more tired than usual; nausea/vomiting; nausea/vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweating more than normal), FATIGUE (more tired than usual), NAUSEA (nausea/vomiting) and VOMITING (nausea/vomiting) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweating more than normal), FATIGUE (more tired than usual), NAUSEA (nausea/vomiting) and VOMITING (nausea/vomiting). On 17-Mar-2021, DYSPNOEA (shortness of breath), HYPERHIDROSIS (sweating more than normal), FATIGUE (more tired than usual), NAUSEA (nausea/vomiting) and VOMITING (nausea/vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter Treatment information was not provided
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Severe Chills; Achy joints; fever; headache; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (Severe Chills), ARTHRALGIA (Achy joints), PYREXIA (fever) and HEADACHE (headache) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.   No Medical History information was reported.  On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (Severe Chills), ARTHRALGIA (Achy joints), PYREXIA (fever) and HEADACHE (headache). At the time of the report, CHILLS (Severe Chills), ARTHRALGIA (Achy joints), PYREXIA (fever) and HEADACHE (headache) 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.   The concomitant medications and treatment details were not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Ear congestion, Feeling abnormal, Oropharyngeal pain, Throat irritation
Clinical narrative: Tightness in chest; Burning in throat; Legs felt weird; Congestion in ears; Sore Throat; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), THROAT IRRITATION (Burning in throat), FEELING ABNORMAL (Legs felt weird), EAR CONGESTION (Congestion in ears) and OROPHARYNGEAL PAIN (Sore Throat) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Fatty liver since an unknown date and Arm injury. Concurrent medical conditions included Diabetes mellitus, Chronic kidney disease (stage 3 kidney disease.) and Addison's disease. Concomitant products included HYDROCORTISONE ACETATE (CORTES) for Addison's disease, INSULIN for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced CHEST DISCOMFORT (Tightness in chest), THROAT IRRITATION (Burning in throat), FEELING ABNORMAL (Legs felt weird), EAR CONGESTION (Congestion in ears) and OROPHARYNGEAL PAIN (Sore Throat). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Tightness in chest), THROAT IRRITATION (Burning in throat), FEELING ABNORMAL (Legs felt weird), EAR CONGESTION (Congestion in ears) and OROPHARYNGEAL PAIN (Sore Throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was also taking cholesterol medicine. She was treated with Z-pac and Allerga. Treatment medicines were not reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain, Peripheral swelling, Pruritus
Clinical narrative: Swollen left arm but not at injection site, in muscle; Itches in left arm but not at injection site; chills; aches/pain; Lightheaded/dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen left arm but not at injection site, in muscle), PAIN (aches/pain), DIZZINESS (Lightheaded/dizziness), PRURITUS (Itches in left arm but not at injection site) and CHILLS (chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) 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) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (aches/pain), DIZZINESS (Lightheaded/dizziness) and CHILLS (chills). On 18-Mar-2021, the patient experienced PRURITUS (Itches in left arm but not at injection site). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen left arm but not at injection site, in muscle). At the time of the report, PERIPHERAL SWELLING (Swollen left arm but not at injection site, in muscle), PAIN (aches/pain), DIZZINESS (Lightheaded/dizziness), PRURITUS (Itches in left arm but not at injection site) and CHILLS (chills) outcome was unknown.            patient is taking medicine for high blood pressure, heart, diabetes (pills) patient has a surgery tomorrow and don't know if he should go or not.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt a little bit weird the night after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little bit weird the night after the first dose) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030120A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-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 FEELING ABNORMAL (felt a little bit weird the night after the first dose). At the time of the report, FEELING ABNORMAL (felt a little bit weird the night after the first dose) outcome was unknown.            Concomitant product use was not provided. No treatment reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-049863 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: patient said she is fine now.TCR document attached.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049863:crosslink
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm where the needle went in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm where the needle went in) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) 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 an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm where the needle went in). At the time of the report, VACCINATION SITE PAIN (sore arm where the needle went in) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were not reported   This case was linked to MOD21-056973, MOD21-057016 (E2B Linked Report).; Sender's Comments:  MOD21-056973:Crosslinked case MOD21-057016:Crosslinked case
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Caller's friend had a sore arm; Caller's friend had intense headache after receiving vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Caller's friend had a sore arm) and HEADACHE (Caller's friend had intense headache after receiving vaccine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Caller's friend had a sore arm) and HEADACHE (Caller's friend had intense headache after receiving vaccine). At the time of the report, PAIN IN EXTREMITY (Caller's friend had a sore arm) and HEADACHE (Caller's friend had intense headache after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Hyperglycaemia, Sunburn
Clinical narrative: Blood sugar went "way high; Sunburn to left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Blood sugar went "way high) and SUNBURN (Sunburn to left arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HYPERGLYCAEMIA (Blood sugar went "way high) and SUNBURN (Sunburn to left arm). On 13-Mar-2021, HYPERGLYCAEMIA (Blood sugar went "way high) had resolved. At the time of the report, SUNBURN (Sunburn to left arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood glucose: high (High) High.         No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2021-065348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received : Updated outcome of event (sun burn) from  unknown to resolved.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pain, Foreign body sensation in eyes, Injection site discomfort, Injection site induration
Clinical narrative: site of injection was stiff; discomfort at the site; eyes felt so gritty; left eye very painful; beyond normal dry eyes both eyes; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOMFORT (discomfort at the site), FOREIGN BODY SENSATION IN EYES (eyes felt so gritty), EYE PAIN (left eye very painful), DRY EYE (beyond normal dry eyes both eyes) and INJECTION SITE INDURATION (site of injection was stiff) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE DISCOMFORT (discomfort at the site), FOREIGN BODY SENSATION IN EYES (eyes felt so gritty), EYE PAIN (left eye very painful) and DRY EYE (beyond normal dry eyes both eyes). On 18-Mar-2021, the patient experienced INJECTION SITE INDURATION (site of injection was stiff). The patient was treated with MACROGOL 400, PROPYLENE GLYCOL (SYSTANE LUBRICANT) (ophthalmic) at an unspecified dose and frequency. At the time of the report, INJECTION SITE DISCOMFORT (discomfort at the site), FOREIGN BODY SENSATION IN EYES (eyes felt so gritty), EYE PAIN (left eye very painful), DRY EYE (beyond normal dry eyes both eyes) and INJECTION SITE INDURATION (site of injection was stiff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache, Pain, Pyrexia
Clinical narrative: body ache; bone ache; chills; headache; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), BONE PAIN (bone ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (high temperature) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (body ache), BONE PAIN (bone ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (high temperature). At the time of the report, PAIN (body ache), BONE PAIN (bone ache), CHILLS (chills), HEADACHE (headache) and PYREXIA (high temperature) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit more soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit more soreness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Knee pain. Concomitant products included METFORMIN for Diabetes, INSULIN and WARFARIN for an unknown indication.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a little bit more soreness). At the time of the report, PAIN IN EXTREMITY (a little bit more soreness) outcome was unknown.            Patient's concomitant medications include blood pressure pills. (unspecified)   No treatment information was reported.   This case was linked to MOD-2021-049827 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: Trouble extending arm due to pain deep located between shoulder and elbow of  left arm; looks swollen; Hardly lift her arm; Pain while lifting/Trouble extending arm due to pain; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), PERIPHERAL SWELLING (looks swollen), LIMB DISCOMFORT (Hardly lift her arm), PAIN IN EXTREMITY (Pain while lifting/Trouble extending arm due to pain) and ARTHRALGIA (Trouble extending arm due to pain deep located between shoulder and elbow of  left arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Blood pressure high.   On 27-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) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 18-Mar-2021, the patient experienced PERIPHERAL SWELLING (looks swollen), LIMB DISCOMFORT (Hardly lift her arm) and PAIN IN EXTREMITY (Pain while lifting/Trouble extending arm due to pain). On 11-May-2021, the patient experienced ARTHRALGIA (Trouble extending arm due to pain deep located between shoulder and elbow of  left arm). At the time of the report, VACCINATION SITE PAIN (Sore arm), PERIPHERAL SWELLING (looks swollen), LIMB DISCOMFORT (Hardly lift her arm), PAIN IN EXTREMITY (Pain while lifting/Trouble extending arm due to pain) and ARTHRALGIA (Trouble extending arm due to pain deep located between shoulder and elbow of  left arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-049843 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow-up added on 11May2021 includes new events were added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049843:First dose
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 17-Dec-1980, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 20-Oct-2020 and the estimated date of delivery was 27-Jul-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported. No treatment information were reported. On 20 Nov 2020 she had a positive pregnancy test.