chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site rash
Clinical narrative: rash on the injection site; tiredness; on and off headache; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tiredness), HEADACHE (on and off headache) and VACCINATION SITE RASH (rash on the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 100L20A) for COVID-19 vaccination.     The patient's past medical history included Allergy multiple (Not specified).  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Jan-2021, the patient experienced FATIGUE (tiredness) and HEADACHE (on and off headache). On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on the injection site). On 13-Jan-2021, FATIGUE (tiredness) had resolved. On 16-Jan-2021, HEADACHE (on and off headache) had resolved. At the time of the report, VACCINATION SITE RASH (rash on the injection site) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Tremor
Clinical narrative: fever was 99.3; shaking; tired; fever/ temperature of 101 to 101.5; shivering; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), FATIGUE (tired), PYREXIA (fever/ temperature of 101 to 101.5), CHILLS (shivering) and PYREXIA (fever was 99.3) 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 COVID-19 (diagnosis of COVID-19 in November) in November 2020.    On 25-Jan-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced TREMOR (shaking), FATIGUE (tired), PYREXIA (fever/ temperature of 101 to 101.5) and CHILLS (shivering). On 27-Jan-2021, the patient experienced PYREXIA (fever was 99.3). At the time of the report, TREMOR (shaking), FATIGUE (tired), PYREXIA (fever/ temperature of 101 to 101.5), CHILLS (shivering) and PYREXIA (fever was 99.3) 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 information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Patient is 4-5 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient is 4-5 weeks 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 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient is 4-5 weeks pregnant). On 05-Feb-2021, EXPOSURE DURING PREGNANCY (Patient is 4-5 weeks pregnant) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPOSURE DURING PREGNANCY (Patient is 4-5 weeks pregnant) to be not related.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: I just took the moderna vaccine yesterday 3FEB2021 and I am currently 7.5 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I just took the moderna vaccine yesterday 3FEB2021 and I am currently 7.5 weeks 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (I just took the moderna vaccine yesterday 3FEB2021 and I am currently 7.5 weeks pregnant). On 03-Feb-2021, EXPOSURE DURING PREGNANCY (I just took the moderna vaccine yesterday 3FEB2021 and I am currently 7.5 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication details given.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hyperthyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 09-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 17-Aug-2020 and the estimated date of delivery was 24-May-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported had history of full term , live child birth currently 2 yrs old.  No Treatment medications was provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Headache; tachycardia due to dehydration; Arm soreness; Fever 100F; Chills; Nausea and vomiting; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia due to dehydration), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever 100F), CHILLS (Chills) and NAUSEA (Nausea and vomiting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included SIMVASTATIN for Cholesterol, SERTRALINE for Depression, CLONAZEPAM for Sleeplessness.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced TACHYCARDIA (tachycardia due to dehydration), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever 100F), CHILLS (Chills), NAUSEA (Nausea and vomiting) and VOMITING (vomiting). On 03-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Feb-2021, TACHYCARDIA (tachycardia due to dehydration), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever 100F), CHILLS (Chills), NAUSEA (Nausea and vomiting) and VOMITING (vomiting) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: high (High) High,100F.         Physician advised the patient to drink water for the symptoms caused due to dehydration. However patient experienced headache while doing any type of forceful acts like coughing, sneezing, clearing throat and bending down.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Vomiting
Clinical narrative: Headache; tachycardia due to dehydration; Arm soreness; Fever 100F; Chills; Nausea and vomiting; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia due to dehydration), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever 100F), CHILLS (Chills) and NAUSEA (Nausea and vomiting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included SIMVASTATIN for Cholesterol, SERTRALINE for Depression, CLONAZEPAM for Sleeplessness.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced TACHYCARDIA (tachycardia due to dehydration), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever 100F), CHILLS (Chills), NAUSEA (Nausea and vomiting) and VOMITING (vomiting). On 03-Feb-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Feb-2021, TACHYCARDIA (tachycardia due to dehydration), PAIN IN EXTREMITY (Arm soreness), PYREXIA (Fever 100F), CHILLS (Chills), NAUSEA (Nausea and vomiting) and VOMITING (vomiting) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: high (High) High,100F.         Physician advised the patient to drink water for the symptoms caused due to dehydration. However patient experienced headache while doing any type of forceful acts like coughing, sneezing, clearing throat and bending down.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Cough, Dyspnoea, Lymphadenopathy
Clinical narrative: Throat tightness; Outbreak on chest; Short of breath; Lymph node in neck; UTI; chills; back ache; Leg swelling; cough; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node in neck), CHILLS (chills), URINARY TRACT INFECTION (UTI), THROAT TIGHTNESS (Throat tightness) and RASH (Outbreak on chest) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension (medical history: hypertension, start/ stop date not given). Concomitant products included AZITHROMYCIN (Phenazopyridine) for UTI.   On 05-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 07-Jan-2021, the patient experienced COUGH (cough) and PERIPHERAL SWELLING (Leg swelling). On 08-Jan-2021, the patient experienced CHILLS (chills) and BACK PAIN (back ache). On 09-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph node in neck) and URINARY TRACT INFECTION (UTI). On 03-Feb-2021, the patient experienced DYSPNOEA (Short of breath). On 04-Feb-2021, the patient experienced RASH (Outbreak on chest). On 05-Feb-2021, the patient experienced THROAT TIGHTNESS (Throat tightness). On 11-Jan-2021, BACK PAIN (back ache) had resolved. On 12-Jan-2021, LYMPHADENOPATHY (Lymph node in neck), CHILLS (chills) and COUGH (cough) had resolved. On 19-Jan-2021, URINARY TRACT INFECTION (UTI) had resolved. On 30-Jan-2021, PERIPHERAL SWELLING (Leg swelling) had resolved. At the time of the report, THROAT TIGHTNESS (Throat tightness), RASH (Outbreak on chest) and DYSPNOEA (Short of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient consulted HCP on 29 JAN 2021 and no treatment was prescribed
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Throat tightness, Urinary tract infection
Clinical narrative: Throat tightness; Outbreak on chest; Short of breath; Lymph node in neck; UTI; chills; back ache; Leg swelling; cough; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node in neck), CHILLS (chills), URINARY TRACT INFECTION (UTI), THROAT TIGHTNESS (Throat tightness) and RASH (Outbreak on chest) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension (medical history: hypertension, start/ stop date not given). Concomitant products included AZITHROMYCIN (Phenazopyridine) for UTI.   On 05-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 07-Jan-2021, the patient experienced COUGH (cough) and PERIPHERAL SWELLING (Leg swelling). On 08-Jan-2021, the patient experienced CHILLS (chills) and BACK PAIN (back ache). On 09-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph node in neck) and URINARY TRACT INFECTION (UTI). On 03-Feb-2021, the patient experienced DYSPNOEA (Short of breath). On 04-Feb-2021, the patient experienced RASH (Outbreak on chest). On 05-Feb-2021, the patient experienced THROAT TIGHTNESS (Throat tightness). On 11-Jan-2021, BACK PAIN (back ache) had resolved. On 12-Jan-2021, LYMPHADENOPATHY (Lymph node in neck), CHILLS (chills) and COUGH (cough) had resolved. On 19-Jan-2021, URINARY TRACT INFECTION (UTI) had resolved. On 30-Jan-2021, PERIPHERAL SWELLING (Leg swelling) had resolved. At the time of the report, THROAT TIGHTNESS (Throat tightness), RASH (Outbreak on chest) and DYSPNOEA (Short of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient consulted HCP on 29 JAN 2021 and no treatment was prescribed
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Received the vaccine while being pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the vaccine while being pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007320A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Sep-2020 and the estimated date of delivery was 27-Jun-2021. On 04-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received the vaccine while being pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  On 04-Feb-2021, EXPOSURE DURING PREGNANCY (Received the vaccine while being 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.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache, Hypoacusis, Tinnitus, Vaccination site pain
Clinical narrative: Some hearing loss; Constant rining in the ears; Pressure in the ears; A little headache; Pain on the Injection Site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HYPOACUSIS (Some hearing loss), TINNITUS (Constant rining in the ears) and EAR DISCOMFORT (Pressure in the ears) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 20-Jan-2021, the patient experienced HYPOACUSIS (Some hearing loss), TINNITUS (Constant rining in the ears) and EAR DISCOMFORT (Pressure in the ears). At the time of the report, HYPOACUSIS (Some hearing loss), TINNITUS (Constant rining in the ears) and EAR DISCOMFORT (Pressure in the ears) 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 relevant concomitant medications were reported.    No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site pain
Clinical narrative: Muscle pain; Joint pain/discomfort on her knees; Sore arm; A Spontaneous report was received from a consumer concerning, a 71 years old, female patient who was administered Moderna (mRNA-1273) and developed sore arm, muscle pain and joint pain/discomfort on her knees.  The patient's medical history was recorded as rheumatoid arthritis. Concomitant product use was not provided.  On 23 Dec 2020, she got first dose of vaccine on her left arm, intramuscularly (Batch number: 011J20A) and on 21 Jan 2021 she got second dose (Batch number: 029L20A) on her left arm. After her first dose, her arm was sore for 2 days and 2 weeks after she also started experiencing muscle and joint pain and felt discomfort on her knees.  For recorded symptoms treatment was given with medicines as Tylenol, Advil, Meloxicam and other: Raloxifene.  Action taken with mRNA-1273 in response to the events were unknown.  The outcome of the events developed sore arm, muscle pain and joint pain/discomfort on her knees  were considered not recovered at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fear, Hallucination
Clinical narrative: saw a greyish black thing, wonders if this is a hallucination; scared the living daylight out of her; A spontaneous report was received from a consumer who was a 84-year-old, female patient and received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a greyish black thing go from the ceiling to the floor/hallucination, and it scared the living daylight out of her/fear.  The patient's medical history included a hip fracture.  Concomitant products known to have been used by the patient, within two weeks prior to the event, included trazadone, clonazepam, Aleve PM and Aleve for hip pain related to surgery.  The patient received their first of two planned doses of mRNA-1273 (lot number unknown) on 06 FEB 2021 for prophylaxis of COVID-19 infection.  The patient stated that after her vaccination she looked up at the wall and saw a greyish black thing go from the ceiling to the floor.  She stated that it was a black glove/streak/paintbrush that went around in a half circle on a white wall.   The patient stated that the pictures on the wall disappeared and then reappeared.  She wondered if it was a hallucination caused by the vaccine.  This lasted a couple minutes.  She was very scared and was crying on the call.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.   The outcome of these events, a greyish black thing go from the ceiling to the floor/hallucination, and it scared the living daylight out of her/fear were  considered recovered.; Reporter'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.  Further information has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0250L20A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy (Mild latex allergy).    On 05-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 08-Oct-2020 and the estimated date of delivery was 15-Jul-2021. On 05-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: No new information was received.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: patient was pregnant and received the first dose of vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (patient was pregnant and received the first dose of vaccine) in a 33-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-May-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (patient was pregnant and received the first dose of vaccine). On 22-Jan-2021, EXPOSURE DURING PREGNANCY (patient was pregnant and received the first dose of 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 products were not reported.  No treatment information was reported.  Number of fetus was reported as 1, previous pregnancies as 3 and gestation period as 27 weeks.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 positive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 positive) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L208) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: covid-19 positive (Positive) COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen normal
Clinical narrative: Pregnant/Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant/Pregnancy) in a 27-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1-2 drinks per week) on 01-Nov-2020. Concurrent medical conditions included Sulfonamide allergy (Sulfa) and Asthma. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and PROGESTERONE from 01-Jan-2020 to an unknown date for Pregnancy.    On 05-Feb-2021 at 1:45 PM, 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 25-Aug-2021. On 05-Feb-2021 at 1:45 PM, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant/Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant/Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2020, Pregnancy test: positive (Positive) Positive. On 19-Jan-2021, Ultrasound antenatal screen normal: normal (normal) no findings.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.  The patient's estimated date of conception was 20-Nov-2020.  It was reported that, the patient had miscarriage in Oct-2020.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: Maternal exposure during pregnancy; Arm Soreness; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) 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 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 an unknown date and the estimated date of delivery was 11-Aug-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) 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 treatment information was provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: patient is pregnant and received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant and received vaccine) in a 28-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 15-Oct-2020 and the estimated date of delivery was 22-Jul-2021. On 27-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant and received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (patient is pregnant and received vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided. No treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound foetal
Clinical narrative: pregnant and received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine) in a 36-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Ovarian cyst ruptured on 23-Nov-2020 and Abortion spontaneous on 18-Jan-2018. Concurrent medical conditions included Asthma since 1992 and Psoriasis in 1998. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 15-Sep-2020 to an unknown date, CALCIUM from 15-Feb-2019 to an unknown date, MONTELUKAST SODIUM from 15-Aug-2019 to an unknown date and ACETYLSALICYLIC ACID (BABY ASPIRIN) from 15-Jan-2021 to an unknown date for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 05-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth 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 (pregnant and received vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2020, Ultrasound foetal: normal (normal) normal. On 08-Nov-2020, Pregnancy test: positive (Positive) Positive. On 30-Nov-2020, Ultrasound foetal: nothing notable in the result of the scan (normal) nothing notable in the result of the scan. On 19-Dec-2020, Prenatal screening test: nothing notable in the result of the scan (normal) nothing notable in the result of the scan.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient gave birth to live full term baby from her previous pregnancy on Dec-2018. No treatment information was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Patient is pregnant and received the first dose of the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history information was provided.  The patient's past medical history included Pregnancy (live full-term baby) on 18-Oct-2018. Concurrent medical conditions included Drug allergy (Amoxicillin) and Drug allergy (Dramamine). Concomitant products included QUETIAPINE for Insomnia, PRENATAL MULTIVITAMIN + DHA for an unknown indication.    On 21-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 08-Jan-2021 and the estimated date of delivery was 16-Oct-2021. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Pregnancy test: positive (Positive) Pregnancy test was positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use on 15-Jan-2021. Concurrent medical conditions included Allergy to antibiotic (Allergic to lorabid, ceclor and amoxicillin.). Concomitant products included MINERALS NOS, VITAMINS NOS4r for Pregnancy.    On 25-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 03-Jan-2021 and the estimated date of delivery was 10-Oct-2021. On 25-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 25-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: fever; Body ache; chill; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), PAIN (Body ache), CHILLS (chill) and FATIGUE (feeling tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PYREXIA (fever), PAIN (Body ache), CHILLS (chill) and FATIGUE (feeling tired). At the time of the report, PYREXIA (fever), PAIN (Body ache), CHILLS (chill) and FATIGUE (feeling tired) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood test, Exposure during pregnancy, Ultrasound scan
Clinical narrative: pregnant; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Miscarriage) on 10-Nov-2020 and Alcohol use on 03-Nov-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation.    On 28-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 11-Oct-2020 and the estimated date of delivery was 17-Aug-2021. On 28-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 28-Jan-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood glucose: normal (normal) normal. In January 2021, Blood test: normal (normal) normal. In 2021, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI right before second shot; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI right before second shot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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) dosage was changed to 1 dosage form. 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 URINARY TRACT INFECTION (UTI right before second shot). At the time of the report, URINARY TRACT INFECTION (UTI right before second shot) outcome was unknown.            No concomitant medications were reported.  Treatment  include antibiotics for UTI .  Action taken with mRNA-1273 in response to the events were not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received on 14-APR-2021 contains significant information of Extra event (UTI right before second shot) . On 02-Jul-2021: Follow up received on 02-Jul-2021 contains Non-Significant information.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received on 17-May-2021: Contact information updated and included no new information.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Flushing, Head discomfort, Heart rate increased
Clinical narrative: High blood pressure; Dizziness; Flushing within 1-2 mins; Flushing from head to toe; Rush of pressure into my head; High heart rate; Sore arm; Whole neck and upper chest was red; Swollen arm; Vasovagal response; Vein sensation; This spontaneous case was reported by an other health care professional and describes the occurrence of FLUSHING (Flushing from head to toe), PRESYNCOPE (Vasovagal response), HEART RATE INCREASED (HIgh heart rate), DIZZINESS (dizziness) and PAIN IN EXTREMITY (Sore arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No medical history was provided by the reporter. Concomitant products included VITAMIN D3 for an unknown indication.  On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced FLUSHING (Flushing from head to toe), PRESYNCOPE (Vasovagal response), HEART RATE INCREASED (HIgh heart rate), DIZZINESS (dizziness), PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen arm). On 05-Feb-2021, the patient experienced ERYTHEMA (Whole neck and upper chest was red), HEAD DISCOMFORT (Rush of pressure into my head), HYPERTENSION (High blood pressure), VEIN DISORDER (Vein sensation) and FLUSHING (Flushing within 1-2 mins). At the time of the report, FLUSHING (Flushing from head to toe), PRESYNCOPE (Vasovagal response), HEART RATE INCREASED (HIgh heart rate), DIZZINESS (dizziness), PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Whole neck and upper chest was red), HEAD DISCOMFORT (Rush of pressure into my head), HYPERTENSION (High blood pressure), VEIN DISORDER (Vein sensation) and FLUSHING (Flushing within 1-2 mins) 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 information provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pain in extremity, Peripheral swelling, Presyncope, Vein disorder
Clinical narrative: High blood pressure; Dizziness; Flushing within 1-2 mins; Flushing from head to toe; Rush of pressure into my head; High heart rate; Sore arm; Whole neck and upper chest was red; Swollen arm; Vasovagal response; Vein sensation; This spontaneous case was reported by an other health care professional and describes the occurrence of FLUSHING (Flushing from head to toe), PRESYNCOPE (Vasovagal response), HEART RATE INCREASED (HIgh heart rate), DIZZINESS (dizziness) and PAIN IN EXTREMITY (Sore arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No medical history was provided by the reporter. Concomitant products included VITAMIN D3 for an unknown indication.  On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced FLUSHING (Flushing from head to toe), PRESYNCOPE (Vasovagal response), HEART RATE INCREASED (HIgh heart rate), DIZZINESS (dizziness), PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen arm). On 05-Feb-2021, the patient experienced ERYTHEMA (Whole neck and upper chest was red), HEAD DISCOMFORT (Rush of pressure into my head), HYPERTENSION (High blood pressure), VEIN DISORDER (Vein sensation) and FLUSHING (Flushing within 1-2 mins). At the time of the report, FLUSHING (Flushing from head to toe), PRESYNCOPE (Vasovagal response), HEART RATE INCREASED (HIgh heart rate), DIZZINESS (dizziness), PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Whole neck and upper chest was red), HEAD DISCOMFORT (Rush of pressure into my head), HYPERTENSION (High blood pressure), VEIN DISORDER (Vein sensation) and FLUSHING (Flushing within 1-2 mins) 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 information provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy
Clinical narrative: Pregnant; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 021L20A) for COVID-19 vaccination.     Concomitant products included BETAXOLOL and 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] for an unknown indication.   On 06-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) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Jun-2020 and the estimated date of delivery was 31-Mar-2021. On an unknown date, the patient experienced PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy. The vaginal delivery occurred, which was reported as Full-term. For neonate 1, the birth weight was 2920 grams (6lbs 7oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Term Birth w/o Complications. At the time of the report, PREGNANCY (Pregnant) outcome was unknown. Not Provided          Treatment drugs were not provided,  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Arthralgia; Fatigue; left arm is 2 inches bigger than her right; the area of injection became red, warm to touch and swollen; the area of injection became red, warm to touch and swollen; the area of injection became red, warm to touch and swollen; experiencing pain and on her left arm where she received the vaccine; soreness and muscle ache; headache; chills; A spontaneous report was received from a nurse concerning a 38-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle ache,headache,chills,injection site pain,swelling,warmth,erythema and peripheral swelling.   The patient's medical history, was not provided.Concomitant medications was not provided by the reporter. On 20 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On  20 Jan  2021, prior to receiving mRNA-1273, the patient felt muscle ache,headache,chills, and on 27 Jan 2021 injection site pain, and on 29 Jan 2021 injection site  swelling,warmth,erythema and 01 Feb 2021  peripheral swelling and she had went to the ER . Lab tests was done included ultrasound ,blood work and covid-19 swab and the results were not provided. Treatment for the events included IV fluid,Tylenol,Bactrim,Keflex,Claritin,Zyrtec,Pepcid,Benadryl and Hydrocortisone cream.Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the events, muscle ache,headache,chills, were considered resolved  and outcome of the events injection site pain,swelling,warmth,erythema and peripheral swelling was unknown.