chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity, Pregnancy test, Ultrasound scan
Clinical narrative: sore arm; Vaccine exposure during pregnancy; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and PAIN IN EXTREMITY (sore arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (compazine), Asthma since 1994 and Hypertension since 2016.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 13-Aug-2020 and the estimated date of delivery was 20-May-2021. On 13-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 13-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2020, Pregnancy test: positive (Positive) positive. On 12-Dec-2020, Ultrasound scan: normal (normal) Normal. On 30-Dec-2020, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       ON 13jan2021, the patient reported that she experienced symptoms of pain in extremity and exposure during pregnancy. Follow up information was provided by the patient who reported that she had no adverse reactions related to her pregnancy.   No treatment information was provided  No concomitant information was provided   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: added
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Myalgia, Pain in extremity, Pregnancy test
Clinical narrative: Pregnant; sore arm; body aches; chills; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and CHILLS (chills) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since January 2018. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], FAMOTIDINE (PEPCID) and PARACETAMOL (TYLENOL) for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Jun-2020 and the estimated date of delivery was 19-Mar-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and CHILLS (chills). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 15-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. On 16-Jan-2021, PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, Pregnancy test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient when received first dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient when received first dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient when received first dose). The delivery occurred  on 21-Jan-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth NOS. On 27-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnant patient when received first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was provided.  No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of  "adverse reaction"  in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.     On an unknown date, the patient experienced Adverse reaction (adverse reaction).   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.  For mRNA-1273 (COVID 19 Vaccine Moderna) administered intramuscularly, the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Neck pain, Pain in extremity, Swelling, Vaccination site cellulitis
Clinical narrative: Vaccination site cellulitis; redness; Swelling; neck pain; arm  pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), PAIN IN EXTREMITY (arm  pain), VACCINATION SITE CELLULITIS (Vaccination site cellulitis), ERYTHEMA (redness) and SWELLING (Swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE 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 15-Jan-2021, the patient experienced NECK PAIN (neck pain) and PAIN IN EXTREMITY (arm  pain). On 25-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Vaccination site cellulitis), ERYTHEMA (redness) and SWELLING (Swelling). The patient was treated with CEPHALEXIN [CEFALEXIN] for Cellulitis, at a dose of 1 dosage form. On 18-Jan-2021, NECK PAIN (neck pain) had resolved. At the time of the report, PAIN IN EXTREMITY (arm  pain), VACCINATION SITE CELLULITIS (Vaccination site cellulitis), ERYTHEMA (redness) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication Pantoprazole Treatment provided was Cephalexin. The patient had no further issues.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up was received on 28- Apr-2021 included no new information On 07-Jul-2021: No new information was received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient is pregnant and received the first dose of the vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine) in a 34-year-old female patient (gravida 5) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Aug-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine). On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine) 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 information was not provided.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Erythema, 3-4 inches lower than the injection site and more medial measuring 3cm wide and 6cm long; The area is slightly tender to touch; A spontaneous report was received from a consumer concerning for herself, a 65-Year-old female patient, who received Moderna's COVID-19 vaccine and experienced Erythema, 3-4 inches lower than the injection site and more medial measuring 3cm wide and 6cm long/ Vaccination site erythema, The area is slightly tender to touch/ Vaccination site pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 19Jan2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: 025J20-2A) via unknown route on Right Arm for COVID-19 infection prophylaxis.  On 21Jan2021, patient noticed an erythema, 3-4 inches lower than the injection site and more medial measuring 3cm wide and 6cm long. The area is slightly tender to touch. It was still present (22Jan2021) but the color has gone a little lighter.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events Erythema, 3-4 inches lower than the injection site and more medial measuring 3cm wide and 6cm long and the area is slightly tender to touch was not recovered, at the time of this report.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events,  and excluding any other etiology, a causal relationship with the event cannot be excluded. Vaccination site erythema and vaccination site pain are consistent with the established safety profile of mRNA-1273 vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with covid-19) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high since an unknown date.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (diagnosed with covid-19). At the time of the report, COVID-19 (diagnosed with covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took unknown high blood pressure medications.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Back pain, Decreased appetite, Dizziness
Clinical narrative: dizzy spells; night sweats; DECREASE IN APPETITE; decrease in interest; decrease in energy; wakes up frequently; very much pain; Very Tired; shortness of breath; abdominal pain; Back Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ABDOMINAL PAIN (abdominal pain), BACK PAIN (Back Pain), DIZZINESS (dizzy spells) and NIGHT SWEATS (night sweats) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04ILZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Depression, Insomnia on 30-Jun-2017, Erectile dysfunction NOS on 30-Jun-2017 and Vitamin D decreased. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 05-Jun-2019 to an unknown date for Depression, SILDENAFIL CITRATE (VIAGRA CONNECT) from 22-Jan-2021 to an unknown date for Erectile dysfunction, SUVOREXANT (BELSOMRA) from 19-Apr-2021 to an unknown date for Insomnia, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) from 11-Nov-2019 to an unknown date for Vitamin D deficiency.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), ABDOMINAL PAIN (abdominal pain), BACK PAIN (Back Pain), PAIN (very much pain) and FATIGUE (Very Tired). On an unknown date, the patient experienced DIZZINESS (dizzy spells), NIGHT SWEATS (night sweats), DECREASED APPETITE (DECREASE IN APPETITE), MALAISE (decrease in interest), ASTHENIA (decrease in energy) and POOR QUALITY SLEEP (wakes up frequently). At the time of the report, DYSPNOEA (shortness of breath), BACK PAIN (Back Pain), PAIN (very much pain) and FATIGUE (Very Tired) had resolved and ABDOMINAL PAIN (abdominal pain), DIZZINESS (dizzy spells), NIGHT SWEATS (night sweats), DECREASED APPETITE (DECREASE IN APPETITE), MALAISE (decrease in interest), ASTHENIA (decrease in energy) and POOR QUALITY SLEEP (wakes up frequently) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (dizzy spells), NIGHT SWEATS (night sweats), DECREASED APPETITE (DECREASE IN APPETITE), MALAISE (decrease in interest), ASTHENIA (decrease in energy) and POOR QUALITY SLEEP (wakes up frequently) to be related. No further causality assessments were provided for DYSPNOEA (shortness of breath), ABDOMINAL PAIN (abdominal pain), BACK PAIN (Back Pain), PAIN (very much pain) and FATIGUE (Very Tired).    concomitant medications include belsomra ,Zoloft ,Viagra, vitamin D.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded. On 26-Apr-2021: Significant Events, Concomitant medication ,product information ,medical history was updated.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Malaise, Night sweats, Pain
Clinical narrative: dizzy spells; night sweats; DECREASE IN APPETITE; decrease in interest; decrease in energy; wakes up frequently; very much pain; Very Tired; shortness of breath; abdominal pain; Back Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ABDOMINAL PAIN (abdominal pain), BACK PAIN (Back Pain), DIZZINESS (dizzy spells) and NIGHT SWEATS (night sweats) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04ILZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Depression, Insomnia on 30-Jun-2017, Erectile dysfunction NOS on 30-Jun-2017 and Vitamin D decreased. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 05-Jun-2019 to an unknown date for Depression, SILDENAFIL CITRATE (VIAGRA CONNECT) from 22-Jan-2021 to an unknown date for Erectile dysfunction, SUVOREXANT (BELSOMRA) from 19-Apr-2021 to an unknown date for Insomnia, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) from 11-Nov-2019 to an unknown date for Vitamin D deficiency.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), ABDOMINAL PAIN (abdominal pain), BACK PAIN (Back Pain), PAIN (very much pain) and FATIGUE (Very Tired). On an unknown date, the patient experienced DIZZINESS (dizzy spells), NIGHT SWEATS (night sweats), DECREASED APPETITE (DECREASE IN APPETITE), MALAISE (decrease in interest), ASTHENIA (decrease in energy) and POOR QUALITY SLEEP (wakes up frequently). At the time of the report, DYSPNOEA (shortness of breath), BACK PAIN (Back Pain), PAIN (very much pain) and FATIGUE (Very Tired) had resolved and ABDOMINAL PAIN (abdominal pain), DIZZINESS (dizzy spells), NIGHT SWEATS (night sweats), DECREASED APPETITE (DECREASE IN APPETITE), MALAISE (decrease in interest), ASTHENIA (decrease in energy) and POOR QUALITY SLEEP (wakes up frequently) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (dizzy spells), NIGHT SWEATS (night sweats), DECREASED APPETITE (DECREASE IN APPETITE), MALAISE (decrease in interest), ASTHENIA (decrease in energy) and POOR QUALITY SLEEP (wakes up frequently) to be related. No further causality assessments were provided for DYSPNOEA (shortness of breath), ABDOMINAL PAIN (abdominal pain), BACK PAIN (Back Pain), PAIN (very much pain) and FATIGUE (Very Tired).    concomitant medications include belsomra ,Zoloft ,Viagra, vitamin D.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded. On 26-Apr-2021: Significant Events, Concomitant medication ,product information ,medical history was updated.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: dizzy spells; night sweats; DECREASE IN APPETITE; decrease in interest; decrease in energy; wakes up frequently; very much pain; Very Tired; shortness of breath; abdominal pain; Back Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ABDOMINAL PAIN (abdominal pain), BACK PAIN (Back Pain), DIZZINESS (dizzy spells) and NIGHT SWEATS (night sweats) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04ILZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Depression, Insomnia on 30-Jun-2017, Erectile dysfunction NOS on 30-Jun-2017 and Vitamin D decreased. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 05-Jun-2019 to an unknown date for Depression, SILDENAFIL CITRATE (VIAGRA CONNECT) from 22-Jan-2021 to an unknown date for Erectile dysfunction, SUVOREXANT (BELSOMRA) from 19-Apr-2021 to an unknown date for Insomnia, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) from 11-Nov-2019 to an unknown date for Vitamin D deficiency.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), ABDOMINAL PAIN (abdominal pain), BACK PAIN (Back Pain), PAIN (very much pain) and FATIGUE (Very Tired). On an unknown date, the patient experienced DIZZINESS (dizzy spells), NIGHT SWEATS (night sweats), DECREASED APPETITE (DECREASE IN APPETITE), MALAISE (decrease in interest), ASTHENIA (decrease in energy) and POOR QUALITY SLEEP (wakes up frequently). At the time of the report, DYSPNOEA (shortness of breath), BACK PAIN (Back Pain), PAIN (very much pain) and FATIGUE (Very Tired) had resolved and ABDOMINAL PAIN (abdominal pain), DIZZINESS (dizzy spells), NIGHT SWEATS (night sweats), DECREASED APPETITE (DECREASE IN APPETITE), MALAISE (decrease in interest), ASTHENIA (decrease in energy) and POOR QUALITY SLEEP (wakes up frequently) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DIZZINESS (dizzy spells), NIGHT SWEATS (night sweats), DECREASED APPETITE (DECREASE IN APPETITE), MALAISE (decrease in interest), ASTHENIA (decrease in energy) and POOR QUALITY SLEEP (wakes up frequently) to be related. No further causality assessments were provided for DYSPNOEA (shortness of breath), ABDOMINAL PAIN (abdominal pain), BACK PAIN (Back Pain), PAIN (very much pain) and FATIGUE (Very Tired).    concomitant medications include belsomra ,Zoloft ,Viagra, vitamin D.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded. On 26-Apr-2021: Significant Events, Concomitant medication ,product information ,medical history was updated.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 71-year-old male 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 was provided).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). On 20-Jan-2021, CHILLS (chills) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 or 2 per week) on 01-Sep-2020, Spontaneous abortion on 23-Sep-2020 and C-section (34 weeks due to an accident) on 15-Aug-2017. Concurrent medical conditions included Allergy to nuts (Tree nut allergy.) and Allergy to nuts (Peanut allergy.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2021 to an unknown date for Pregnancy, VITAMIN B6 and DOXYLAMINE SUCCINATE (UNISOM 2) for an unknown indication.    On 05-Feb-2021 at 10:13 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 18-Nov-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 05-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2020, Pregnancy test: (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-230191 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Second dose, event details added. On 07-Aug-2021: Follow up information received no new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: Stiff muscles; Muscle achy; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Stiff muscles) and MYALGIA (Muscle achy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Urinary tract infection.   On 21-Jan-2021 at 7:30 AM, 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 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 22-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff muscles) and MYALGIA (Muscle achy). The patient was treated with PARACETAMOL (TYLENOL) on 21-Jan-2021 for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL STIFFNESS (Stiff muscles) and MYALGIA (Muscle achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Additional information received included no new significant information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle fatigue, Myalgia
Clinical narrative: muscle fatigue; severe fatigue; Headache on and off; mild fatigue; mild headache; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (mild fatigue), HEADACHE (mild headache), MYALGIA (muscle pain), MUSCLE FATIGUE (muscle fatigue) and FATIGUE (severe fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced FATIGUE (mild fatigue), HEADACHE (mild headache) and MYALGIA (muscle pain). On 17-Jan-2021, the patient experienced MUSCLE FATIGUE (muscle fatigue), FATIGUE (severe fatigue) and HEADACHE (Headache on and off). At the time of the report, FATIGUE (mild fatigue), HEADACHE (mild headache), MYALGIA (muscle pain), MUSCLE FATIGUE (muscle fatigue), FATIGUE (severe fatigue) and HEADACHE (Headache on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: arm was hot to touch at injection site; red mark about 5 inches around injection area; injection site itching; A spontaneous report was received from a consumer concerning a 36-years-old, female patient who experienced arm was hot to touch at injection site, red mark about 5 inches around injection area and injection site itching.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 13 Jan 2021, approximately seven days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 027L20A] intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021, the patient stated that her arm was hot to touch with a big red mark about 5'' around injection site that extended to the middle of her arm. Also, the site was very red and itchy. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events arm was hot to touch at injection site, red mark about 5 inches around injection area and injection site itching were unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nausea
Clinical narrative: weakness; chills; head hurting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (chills), HEADACHE (head hurting) and NAUSEA (nausea) in a 71-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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (weakness), CHILLS (chills), HEADACHE (head hurting) and NAUSEA (nausea). At the time of the report, ASTHENIA (weakness), CHILLS (chills), HEADACHE (head hurting) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: NNI. reporter declined to give email or fax and declined FU
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Received covid-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Received covid-19 vaccine while pregnant) in a 30-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 062G20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Prior alcohol use.). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and PROGESTERONE for Pregnancy.   On 29-Dec-2020 at 7:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. The patient's last menstrual period was on 03-Dec-2020 and the estimated date of delivery was 09-Sep-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Received covid-19 vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 25-Jan-2021, EXPOSURE DURING PREGNANCY (Received covid-19 vaccine while pregnant) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Additional information received included no new information.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs are provided. No treatment.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: redness had a little bit of a fever in it; arm a little bit of a knot on it; arm was red and splotchy; arm started to swell up a little bit; arm was starting to itch; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE WARMTH (redness had a little bit of a fever in it), INJECTION SITE MASS (arm a little bit of a knot on it), INJECTION SITE ERYTHEMA (arm was red and splotchy), INJECTION SITE SWELLING (arm started to swell up a little bit) and INJECTION SITE PRURITUS (arm was starting to itch) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE WARMTH (redness had a little bit of a fever in it), INJECTION SITE MASS (arm a little bit of a knot on it), INJECTION SITE ERYTHEMA (arm was red and splotchy), INJECTION SITE SWELLING (arm started to swell up a little bit) and INJECTION SITE PRURITUS (arm was starting to itch). On 22-Jan-2021, INJECTION SITE WARMTH (redness had a little bit of a fever in it), INJECTION SITE MASS (arm a little bit of a knot on it), INJECTION SITE ERYTHEMA (arm was red and splotchy) and INJECTION SITE SWELLING (arm started to swell up a little bit) had resolved. At the time of the report, INJECTION SITE PRURITUS (arm was starting to itch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up received on 16 April 2021, NNI
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Malaise, Pyrexia
Clinical narrative: Redness on her arm; Diarrhea; just does not feel great; Fever of100; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on her arm), DIARRHOEA (Diarrhea), MALAISE (just does not feel great) and PYREXIA (Fever of100) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20a) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced ERYTHEMA (Redness on her arm), DIARRHOEA (Diarrhea), MALAISE (just does not feel great) and PYREXIA (Fever of100). At the time of the report, ERYTHEMA (Redness on her arm), DIARRHOEA (Diarrhea), MALAISE (just does not feel great) and PYREXIA (Fever of100) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on June 8th. Pt reports all AE's resolved.  Denied further follow up.
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE for Rheumatoid arthritis.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medical also include Orencia by infusion .  Treatment information was not provided.   unknown; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID Test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID Test) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes since 2010.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced COVID-19 (Positive COVID Test). The patient was treated with PARACETAMOL (TYLENOL) for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (Positive COVID Test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, SARS-CoV-2 test: negati ve (Negative) negative. On 19-Jan-2021, SARS-CoV-2 test: positive (Positive) positive. On 30-Jan-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had symptoms cough, headache, Muscle aches and nasal congestion.  No relevant concomitant medications were reported.   No Treatment information was provided   This case was linked to MOD-2021-275500.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up information received included medical history, laboratory details, treatment drug and clinical information.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information is not expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site wam to touch; Redness, swelling, itchiness at the injection site; Redness, swelling, itchiness at the injection site; Redness, swelling, itchiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site wam to touch), VACCINATION SITE PRURITUS (Redness, swelling, itchiness at the injection site), VACCINATION SITE SWELLING (Redness, swelling, itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness, swelling, itchiness at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site wam to touch), VACCINATION SITE PRURITUS (Redness, swelling, itchiness at the injection site), VACCINATION SITE SWELLING (Redness, swelling, itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness, swelling, itchiness at the injection site). At the time of the report, VACCINATION SITE WARMTH (Injection site wam to touch), VACCINATION SITE PRURITUS (Redness, swelling, itchiness at the injection site), VACCINATION SITE SWELLING (Redness, swelling, itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness, swelling, itchiness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   It was reported that patient received second dose of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-JUN-2021 contains added vaccine information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Injection site itchy; Injection site rash; Injection site red; Injection site soreness from needle; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site soreness from needle) 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 14-Jan-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site soreness from needle). At the time of the report, VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE RASH (Injection site rash), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site soreness from needle) outcome was unknown.        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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site hypersensitivity, Sleep disorder
Clinical narrative: a knot formed at the injection site; did not sleep and it's not hard for me to fall asleep; redness at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE HYPERSENSITIVITY (a knot formed at the injection site), SLEEP DISORDER (did not sleep and it's not hard for me to fall asleep) and ERYTHEMA (redness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for moderna.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE HYPERSENSITIVITY (a knot formed at the injection site), SLEEP DISORDER (did not sleep and it's not hard for me to fall asleep) and ERYTHEMA (redness at the injection site). At the time of the report, INJECTION SITE HYPERSENSITIVITY (a knot formed at the injection site), SLEEP DISORDER (did not sleep and it's not hard for me to fall asleep) and ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: hot, red, itchy rash from the injection site to top of her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot, red, itchy rash from the injection site to top of her shoulder/hotness), VACCINATION SITE PRURITUS (hot, red, itchy rash from the injection site to top of her shoulder) and VACCINATION SITE RASH (hot, red, itchy rash from the injection site to top of her shoulder) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot, red, itchy rash from the injection site to top of her shoulder/hotness), VACCINATION SITE PRURITUS (hot, red, itchy rash from the injection site to top of her shoulder) and VACCINATION SITE RASH (hot, red, itchy rash from the injection site to top of her shoulder). At the time of the report, VACCINATION SITE WARMTH (hot, red, itchy rash from the injection site to top of her shoulder/hotness) outcome was unknown and VACCINATION SITE PRURITUS (hot, red, itchy rash from the injection site to top of her shoulder) and VACCINATION SITE RASH (hot, red, itchy rash from the injection site to top of her shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. The patient was taking allergy medicine as a corrective treatment.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received which contained no new information
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Flushing, Hyperhidrosis
Clinical narrative: Flushing; break into sweats; on and off chills; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing), HYPERHIDROSIS (break into sweats) and CHILLS (on and off chills) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included levothyroxine for Hypothyroidism.    On 09-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 CHILLS (on and off chills). On 21-Jan-2021, the patient experienced FLUSHING (Flushing) and HYPERHIDROSIS (break into sweats). At the time of the report, FLUSHING (Flushing), HYPERHIDROSIS (break into sweats) and CHILLS (on and off chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-Apr-2021, Contains non-significant information
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case reported by a consumer, describes the occurrence of maternal exposure during pregnancy (pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 043L20A) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. The patient's last menstrual period was May 2020 and estimated date of delivery was Mar 14, 2021. On an unknown date, patient experienced maternal exposure during pregnancy (pregnant). The patient received mRNA-1273 (Moderna COVID-19 vaccine) during pregnancy. At the time of the report, maternal exposure during pregnancy (pregnant) resolved/not provided. No concomitant medications or treatment information reported. Most recent follow-up information incorporated above included: Feb 25, 2021: Additional information reported: address and contact details of the reporter, lot number, LMP, estimated due date and gestational stage.