chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Glucose tolerance test, Human chorionic gonadotropin, Pregnancy test, Ultrasound scan
Clinical narrative: Got both shots of Moderna COVID vaccine while pregnant and is calling to enroll in pregnancy registry.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Got both shots of Moderna COVID vaccine while pregnant and is calling to enroll in pregnancy registry.) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic, Sulfonamide allergy, Asthma and Depression. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and SERTRALINE 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 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Dec-2020 and the estimated date of delivery was 27-Sep-2021. On 14-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Got both shots of Moderna COVID vaccine while pregnant and is calling to enroll in pregnancy registry.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Got both shots of Moderna COVID vaccine while pregnant and is calling to enroll in pregnancy registry.) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Pregnancy test: positive. On an unknown date, Glucose tolerance test: normal. On an unknown date, Human chorionic gonadotropin: fine. On an unknown date, Ultrasound scan: normal.         Additional tests (dates not specified) included a normal ultrasound, a glucose test and human chorionic gonadotropin reported to be "fine".
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest discomfort, Headache, Heart rate increased
Clinical narrative: Fast Heart Beat; Tightness in chest on left side; knee swelled; lower right back ache; Sore muscles; shoulder pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast Heart Beat), CHEST DISCOMFORT (Tightness in chest on left side), JOINT SWELLING (knee swelled), BACK PAIN (lower right back ache) and MYALGIA (Sore muscles) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0121N20A and 011120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Drug allergy (sulfur). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LISINOPRIL and LOVASTATIN for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced HEART RATE INCREASED (Fast Heart Beat), CHEST DISCOMFORT (Tightness in chest on left side), JOINT SWELLING (knee swelled), BACK PAIN (lower right back ache), MYALGIA (Sore muscles), ARTHRALGIA (shoulder pain) and HEADACHE (headache). At the time of the report, HEART RATE INCREASED (Fast Heart Beat), CHEST DISCOMFORT (Tightness in chest on left side), JOINT SWELLING (knee swelled), BACK PAIN (lower right back ache), MYALGIA (Sore muscles), ARTHRALGIA (shoulder pain) and HEADACHE (headache) outcome was unknown.             Treatment details were not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Myalgia
Clinical narrative: Fast Heart Beat; Tightness in chest on left side; knee swelled; lower right back ache; Sore muscles; shoulder pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast Heart Beat), CHEST DISCOMFORT (Tightness in chest on left side), JOINT SWELLING (knee swelled), BACK PAIN (lower right back ache) and MYALGIA (Sore muscles) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0121N20A and 011120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Drug allergy (sulfur). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LISINOPRIL and LOVASTATIN for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced HEART RATE INCREASED (Fast Heart Beat), CHEST DISCOMFORT (Tightness in chest on left side), JOINT SWELLING (knee swelled), BACK PAIN (lower right back ache), MYALGIA (Sore muscles), ARTHRALGIA (shoulder pain) and HEADACHE (headache). At the time of the report, HEART RATE INCREASED (Fast Heart Beat), CHEST DISCOMFORT (Tightness in chest on left side), JOINT SWELLING (knee swelled), BACK PAIN (lower right back ache), MYALGIA (Sore muscles), ARTHRALGIA (shoulder pain) and HEADACHE (headache) outcome was unknown.             Treatment details were not provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Sleep deficit, Urticaria
Clinical narrative: hives; itching; kept me awake; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (itching) and SLEEP DEFICIT (kept me awake) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Feb-2021, the patient experienced URTICARIA (hives), PRURITUS (itching) and SLEEP DEFICIT (kept me awake). At the time of the report, URTICARIA (hives), PRURITUS (itching) and SLEEP DEFICIT (kept me awake) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product or treatment was not provided by the reporter.  Patient reports events "lasted about ten hours on the night of February 6th and kept me awakeall night. It was on my chest, neck, and arms. It went away in 8-9 hours; gone next day"
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: fever of 99.4; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 99.4) and PAIN IN EXTREMITY (sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PYREXIA (fever of 99.4) and PAIN IN EXTREMITY (sore arm). At the time of the report, PYREXIA (fever of 99.4) and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 99.4 Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous retrospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The cesarean delivery occurred on 04-Feb-2021, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Pre-Term Birth w/o Complications. On 18-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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.   No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever; Headache; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) 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) dosage form. On an unknown date, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment or concomitant medications were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Injection site erythema, Injection site rash, Muscle tightness
Clinical narrative: rash at the site of injection (redder, more raised and not getting better); redder at the site of injection; interesting, very weird pain within armpit of the same arm; very very stiff and tight neck; continued headache; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE RASH (rash at the site of injection (redder, more raised and not getting better)), INJECTION SITE ERYTHEMA (redder at the site of injection), AXILLARY PAIN (interesting, very weird pain within armpit of the same arm), MUSCLE TIGHTNESS (very very stiff and tight neck) and HEADACHE (continued headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE RASH (rash at the site of injection (redder, more raised and not getting better)), INJECTION SITE ERYTHEMA (redder at the site of injection), AXILLARY PAIN (interesting, very weird pain within armpit of the same arm), MUSCLE TIGHTNESS (very very stiff and tight neck) and HEADACHE (continued headache). At the time of the report, INJECTION SITE RASH (rash at the site of injection (redder, more raised and not getting better)), INJECTION SITE ERYTHEMA (redder at the site of injection), AXILLARY PAIN (interesting, very weird pain within armpit of the same arm), MUSCLE TIGHTNESS (very very stiff and tight neck) and HEADACHE (continued headache) outcome was unknown.        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.   No treatment or concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: No specific follow-up information recorded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site hot; Itchy at injection site; Injection site red; Injection site swollen; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Injection site hot), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2a) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event and No adverse event.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site hot), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site swollen). At the time of the report, INJECTION SITE WARMTH (Injection site hot), INJECTION SITE PRURITUS (Itchy at injection site), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment or concomitant medications were reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cognitive disorder, Dysstasia, Physical disability, Walking disability
Clinical narrative: patient can no longer walk with a walker (wheelchair only now); physical downturn; hard to stand; has been weaker since; cognitive downturn; This spontaneous case was reported by a consumer and describes the occurrence of WALKING DISABILITY (patient can no longer walk with a walker (wheelchair only now)), PHYSICAL DISABILITY (physical downturn), DYSSTASIA (hard to stand), ASTHENIA (has been weaker since) and COGNITIVE DISORDER (cognitive downturn) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease since 2014.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PHYSICAL DISABILITY (physical downturn), DYSSTASIA (hard to stand), ASTHENIA (has been weaker since) and COGNITIVE DISORDER (cognitive downturn). On 04-Feb-2021, the patient experienced WALKING DISABILITY (patient can no longer walk with a walker (wheelchair only now)). At the time of the report, WALKING DISABILITY (patient can no longer walk with a walker (wheelchair only now)), PHYSICAL DISABILITY (physical downturn), DYSSTASIA (hard to stand), ASTHENIA (has been weaker since) and COGNITIVE DISORDER (cognitive downturn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Follow-up received no new information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site rash, Myalgia
Clinical narrative: Fatigue; Bad rash at the injection site and elbow; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (headache), MYALGIA (body ache) and INJECTION SITE RASH (Bad rash at the injection site and elbow) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) 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 10-Feb-2021, the patient experienced HEADACHE (headache) and MYALGIA (body ache). On 11-Feb-2021, the patient experienced FATIGUE (Fatigue) and INJECTION SITE RASH (Bad rash at the injection site and elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue), HEADACHE (headache) and MYALGIA (body ache) was resolving and INJECTION SITE RASH (Bad rash at the injection site and elbow) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided/unknown by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Myalgia
Clinical narrative: muscle aches; headache; chest pains; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle aches), HEADACHE (headache) and CHEST PAIN (chest pains) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 086M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced MYALGIA (muscle aches), HEADACHE (headache) and CHEST PAIN (chest pains). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MYALGIA (muscle aches), HEADACHE (headache) and CHEST PAIN (chest pains) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Relevant concomitant medications were not reported. Patient thinks it was due to her shoveling snow but wasn't sure.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Nausea; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), CHILLS (chills) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea), CHILLS (chills) and PYREXIA (fever). At the time of the report, NAUSEA (Nausea), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes in clavicle region; This spontaneous case was reported by a non-health professional and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes in clavicle region) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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 11-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in clavicle region). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes in clavicle region) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Vaccination site erythema
Clinical narrative: diarrhea; headache; redness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, DIARRHOEA (diarrhea), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.            Concomitant product use was not provided. Treatment information was not  provided.; Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Rash
Clinical narrative: Arm Pain; Aches; Rash behind her neck; Chills; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), PAIN (Aches), RASH (Rash behind her neck), CHILLS (Chills) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 15-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), PAIN (Aches), RASH (Rash behind her neck), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Arm Pain), PAIN (Aches), RASH (Rash behind her neck), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products usage were not reported by the reporter. Treatment details not included.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: flare up of arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (flare up of arthritis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included CELECOXIB (CELEBREX) for Arthritis.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ARTHRITIS (flare up of arthritis). At the time of the report, ARTHRITIS (flare up of arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, Chills, Fatigue, Headache, Malaise
Clinical narrative: Pain all over the body; feeling really sick; Feel tired; terrible shattering chills; pain on the head, like stabbing pain; very high fever 102°F; turned out negative; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (turned out negative), PAIN (Pain all over the body), MALAISE (feeling really sick), FATIGUE (Feel tired) and CHILLS (terrible shattering chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL and VITAMINS NOS for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 08-Feb-2021, the patient experienced ANTIBODY TEST NEGATIVE (turned out negative). On an unknown date, the patient experienced PAIN (Pain all over the body), MALAISE (feeling really sick), FATIGUE (Feel tired), CHILLS (terrible shattering chills), HEADACHE (pain on the head, like stabbing pain) and PYREXIA (very high fever 102°F). At the time of the report, ANTIBODY TEST NEGATIVE (turned out negative), PAIN (Pain all over the body), MALAISE (feeling really sick), FATIGUE (Feel tired), CHILLS (terrible shattering chills) and HEADACHE (pain on the head, like stabbing pain) outcome was unknown and PYREXIA (very high fever 102°F) had resolved.            Treatment medication not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event (antibody test negative) has been provided at this time.   This case was linked to US-MODERNATX, INC.-MOD-2021-014817 (E2B Linked Report). This case was linked to MOD-2021-014817 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event (antibody test negative) has been provided at this time. US-MODERNATX, INC.-MOD-2021-014817:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Pain all over the body; feeling really sick; Feel tired; terrible shattering chills; pain on the head, like stabbing pain; very high fever 102°F; turned out negative; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (turned out negative), PAIN (Pain all over the body), MALAISE (feeling really sick), FATIGUE (Feel tired) and CHILLS (terrible shattering chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL and VITAMINS NOS for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 08-Feb-2021, the patient experienced ANTIBODY TEST NEGATIVE (turned out negative). On an unknown date, the patient experienced PAIN (Pain all over the body), MALAISE (feeling really sick), FATIGUE (Feel tired), CHILLS (terrible shattering chills), HEADACHE (pain on the head, like stabbing pain) and PYREXIA (very high fever 102°F). At the time of the report, ANTIBODY TEST NEGATIVE (turned out negative), PAIN (Pain all over the body), MALAISE (feeling really sick), FATIGUE (Feel tired), CHILLS (terrible shattering chills) and HEADACHE (pain on the head, like stabbing pain) outcome was unknown and PYREXIA (very high fever 102°F) had resolved.            Treatment medication not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event (antibody test negative) has been provided at this time.   This case was linked to US-MODERNATX, INC.-MOD-2021-014817 (E2B Linked Report). This case was linked to MOD-2021-014817 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event (antibody test negative) has been provided at this time. US-MODERNATX, INC.-MOD-2021-014817:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: Big oval patch between elbow and shoulder, really itchy; Arm is very tender; pruritus; bumps all over body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Big oval patch between elbow and shoulder, really itchy), PAIN IN EXTREMITY (Arm is very tender), PRURITUS (pruritus) and RASH (bumps all over body) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced URTICARIA (Big oval patch between elbow and shoulder, really itchy), PAIN IN EXTREMITY (Arm is very tender), PRURITUS (pruritus) and RASH (bumps all over body). At the time of the report, URTICARIA (Big oval patch between elbow and shoulder, really itchy), PAIN IN EXTREMITY (Arm is very tender), PRURITUS (pruritus) and RASH (bumps all over body) 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.   Concomitant medication were not reported by the reporter. Treatment included diphenhydramine, Hydrochloride, famotidine and allergy medication azelastine.   Reporter did not allow further contact
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Maternal exposure during pregnancy, Myalgia, Pregnancy test
Clinical narrative: Pregnancy; Headache; Fatigue; Body ache; Low Grade Fever; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Body ache) and PYREXIA (Low Grade Fever) in a 35-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion, Alcohol use (A year ago), Marijuana use (Not in the last 6 months) and Pregnancy (live full-time birth). Concomitant products included FOLIC ACID and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Jan-2021 and the estimated date of delivery was 18-Oct-2021. On 08-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Body ache) and PYREXIA (Low Grade Fever). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Body ache) and PYREXIA (Low Grade Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had 2 previous pregnancies, 1 with spontaneous abortion and 1 with live birth outcome. Concomitant drug included PHA.   This case was linked to MOD-2021-267287 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pregnancy; Headache; Fatigue; Body ache; Low Grade Fever; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Body ache) and PYREXIA (Low Grade Fever) in a 35-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion, Alcohol use (A year ago), Marijuana use (Not in the last 6 months) and Pregnancy (live full-time birth). Concomitant products included FOLIC ACID and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Jan-2021 and the estimated date of delivery was 18-Oct-2021. On 08-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Body ache) and PYREXIA (Low Grade Fever). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Body ache) and PYREXIA (Low Grade Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Pregnancy test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had 2 previous pregnancies, 1 with spontaneous abortion and 1 with live birth outcome. Concomitant drug included PHA.   This case was linked to MOD-2021-267287 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Hard knot at vaccine site; Injection site itch; Injection site red; A spontaneous report was received from a physician concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hard knot at injection site/injection site induration, injection site itch/injection site pruritus and injection site red/injection site erythema.  The patient's medical history was not provided. Concomitant medication list was not provided by the reporter.  On 28 Dec 2020 , approximately nine days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039k20a) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 6 Jan 2021, nine days after receiving mRNA-1273, the patient reported that she developed  1" diameter hard knot at the vaccine administration site that was red and itchy. Treatment given for the event included two cold packs as she could not take antihistamine because she was working.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events; hard knot at injection site, injection site itch and injection site red was unknown.  The reporting physician assessed the events hard knot at injection site, injection site itch and injection site red as related.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Area around shot is red; Area around shot is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Area around shot is red) and VACCINATION SITE SWELLING (Area around shot is swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Area around shot is red) and VACCINATION SITE SWELLING (Area around shot is swollen). At the time of the report, VACCINATION SITE ERYTHEMA (Area around shot is red) and VACCINATION SITE SWELLING (Area around shot is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details not reported by the reporter. Reporter details were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Pyrexia, Therapeutic response unexpected
Clinical narrative: recover from congestive lungs; After the second dose noticed that her lungs improved; feverish; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (recover from congestive lungs), THERAPEUTIC RESPONSE UNEXPECTED (After the second dose noticed that her lungs improved) and PYREXIA (feverish) in an 117-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung congestion.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, 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 experienced PRE-EXISTING CONDITION IMPROVED (recover from congestive lungs), THERAPEUTIC RESPONSE UNEXPECTED (After the second dose noticed that her lungs improved) and PYREXIA (feverish). At the time of the report, PRE-EXISTING CONDITION IMPROVED (recover from congestive lungs) and THERAPEUTIC RESPONSE UNEXPECTED (After the second dose noticed that her lungs improved) had resolved and PYREXIA (feverish) outcome was unknown. Not Provided          Action taken with mRNA-1273 related to events was not applicable.  Concomitant medication details was not reported by the reporter. Treatment details included Lasix 100 mg, blood thinner, lowdose of insulin.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash erythematous
Clinical narrative: Swollen glands near her ear and on her neck; Rash that was red at the top of her face near her ear; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Rash that was red at the top of her face near her ear) and LYMPHADENOPATHY (Swollen glands near her ear and on her neck) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, OLMESARTAN MEDOXOMIL, ROSUVASTATIN, DILTIAZEM, SITAGLIPTIN and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Rash that was red at the top of her face near her ear). On 14-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen glands near her ear and on her neck). At the time of the report, RASH ERYTHEMATOUS (Rash that was red at the top of her face near her ear) and LYMPHADENOPATHY (Swollen glands near her ear and on her neck) 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.   Treatment for the event included cipro-dexamethasone ear drops. azithromycin.  Patient took a steroid shot (doesn't know the name) on January 26th.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Reporter contact information added.Patient demographics added On 26-Apr-2021: Email address updated (No New information) On 12-May-2021: Non significant follow-up appended into AER MOD-2021-014849
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dyspnoea
Clinical narrative: Dry Mouth; Difficulty Breathing; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry Mouth) and DYSPNOEA (Difficulty Breathing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concurrent medical conditions included Allergy. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED CO).    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DRY MOUTH (Dry Mouth) and DYSPNOEA (Difficulty Breathing). At the time of the report, DRY MOUTH (Dry Mouth) and DYSPNOEA (Difficulty Breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included albuterol inhaler.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Memory impairment, Pain
Clinical narrative: pain in the arm; Confused; pain in the body; memory problem; fever; missed dose; Tingling; Dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling), DIZZINESS (Dizzy), PAIN IN EXTREMITY (pain in the arm), CONFUSIONAL STATE (Confused) and PAIN (pain in the body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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-Feb-2021, the patient experienced PARAESTHESIA (Tingling), DIZZINESS (Dizzy) and FATIGUE (Fatigue). On 18-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm), CONFUSIONAL STATE (Confused), PAIN (pain in the body), MEMORY IMPAIRMENT (memory problem) and PYREXIA (fever). At the time of the report, PARAESTHESIA (Tingling), DIZZINESS (Dizzy), PAIN IN EXTREMITY (pain in the arm), CONFUSIONAL STATE (Confused), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (missed dose) outcome was unknown, PAIN (pain in the body) and PYREXIA (fever) had resolved and MEMORY IMPAIRMENT (memory problem) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details was not reported by the reporter. Treatment details was not reported by the reporter. Patient was afraid of getting Alzheimer from the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Follow up received on 18-FEB-2021. New events was reported. On 18-Jun-2021: Follow up received on 18-JUN-2021. Reporter Email was reported. Events was added and outcome of events memory impairment, fever and body pain was updated.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Product dose omission issue, Pyrexia
Clinical narrative: pain in the arm; Confused; pain in the body; memory problem; fever; missed dose; Tingling; Dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling), DIZZINESS (Dizzy), PAIN IN EXTREMITY (pain in the arm), CONFUSIONAL STATE (Confused) and PAIN (pain in the body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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-Feb-2021, the patient experienced PARAESTHESIA (Tingling), DIZZINESS (Dizzy) and FATIGUE (Fatigue). On 18-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm), CONFUSIONAL STATE (Confused), PAIN (pain in the body), MEMORY IMPAIRMENT (memory problem) and PYREXIA (fever). At the time of the report, PARAESTHESIA (Tingling), DIZZINESS (Dizzy), PAIN IN EXTREMITY (pain in the arm), CONFUSIONAL STATE (Confused), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (missed dose) outcome was unknown, PAIN (pain in the body) and PYREXIA (fever) had resolved and MEMORY IMPAIRMENT (memory problem) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details was not reported by the reporter. Treatment details was not reported by the reporter. Patient was afraid of getting Alzheimer from the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Follow up received on 18-FEB-2021. New events was reported. On 18-Jun-2021: Follow up received on 18-JUN-2021. Reporter Email was reported. Events was added and outcome of events memory impairment, fever and body pain was updated.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: received both doses of the vaccine and is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received both doses of the vaccine and is pregnant) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hypercholesteremia.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 07-Oct-2020 and the estimated date of delivery was 14-Jul-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received both doses of the vaccine and is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (received both doses of the vaccine and is pregnant) had resolved. Not Provided          Concomitant medication were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Patient details are updated