chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: Missed second vaccination dose.; A spontaneous report was received from a consumer concerning a female patient of unknown age who missed second vaccination dose.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     Patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 14-JAN-2021 intramuscularly for prophylaxis of COVID-19 infection.    Caller said one of her daughters (a nurse) received her first vaccine on 13-Jan-2021. The caller received her vaccination on 14-JAN-2021 along with her other daughter (also a nurse). The second shot was due on 11-Feb-2021, but the clinic nurse said that none of family members could receive the shot since they were in quarantine and the nurse refused to make an appointment for any of them. The nurse said that the caller and her 2 daughters had to start the shot series all over again. Caller did not want to do that, and has relatives who are physicians that said starting the vaccine series over is not necessary.  Laboratory details included SARS COV-2 positive.    No treatment medications were reported.     Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event,  missed second vaccination dose, was considered as unknown.; Reporter's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated Adverse Events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dry mouth, Faeces discoloured, Faeces pale, Headache
Clinical narrative: soft stool and diarrhea, light colored; light colored; stool is very grainy or sandy and dark colored, like ash colored; her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker; Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind; slight headache; pain in the muscle of the arm; pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), DRY MOUTH (her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker), LIP DRY (Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind), DIARRHOEA (soft stool and diarrhea, light colored) and FAECES PALE (light colored) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M007204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Anxiety. Concomitant products included PREDNISONE, FOLIC ACID, IRON and GABAPENTIN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm). On 19-Feb-2021, the patient experienced HEADACHE (slight headache) and MYALGIA (pain in the muscle of the arm). On 04-Mar-2021, the patient experienced DRY MOUTH (her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker) and LIP DRY (Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind). On 05-Mar-2021, the patient experienced FAECES DISCOLOURED (stool is very grainy or sandy and dark colored, like ash colored). On an unknown date, the patient experienced DIARRHOEA (soft stool and diarrhea, light colored) and FAECES PALE (light colored). On 20-Feb-2021, HEADACHE (slight headache) and MYALGIA (pain in the muscle of the arm) had resolved. On 21-Feb-2021, PAIN IN EXTREMITY (pain in her arm) had resolved. On 05-Mar-2021, DIARRHOEA (soft stool and diarrhea, light colored) and FAECES PALE (light colored) had resolved. At the time of the report, DRY MOUTH (her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker), LIP DRY (Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind) and FAECES DISCOLOURED (stool is very grainy or sandy and dark colored, like ash colored) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lip dry, Myalgia, Pain in extremity
Clinical narrative: soft stool and diarrhea, light colored; light colored; stool is very grainy or sandy and dark colored, like ash colored; her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker; Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind; slight headache; pain in the muscle of the arm; pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her arm), DRY MOUTH (her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker), LIP DRY (Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind), DIARRHOEA (soft stool and diarrhea, light colored) and FAECES PALE (light colored) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. M007204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis and Anxiety. Concomitant products included PREDNISONE, FOLIC ACID, IRON and GABAPENTIN for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in her arm). On 19-Feb-2021, the patient experienced HEADACHE (slight headache) and MYALGIA (pain in the muscle of the arm). On 04-Mar-2021, the patient experienced DRY MOUTH (her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker) and LIP DRY (Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind). On 05-Mar-2021, the patient experienced FAECES DISCOLOURED (stool is very grainy or sandy and dark colored, like ash colored). On an unknown date, the patient experienced DIARRHOEA (soft stool and diarrhea, light colored) and FAECES PALE (light colored). On 20-Feb-2021, HEADACHE (slight headache) and MYALGIA (pain in the muscle of the arm) had resolved. On 21-Feb-2021, PAIN IN EXTREMITY (pain in her arm) had resolved. On 05-Mar-2021, DIARRHOEA (soft stool and diarrhea, light colored) and FAECES PALE (light colored) had resolved. At the time of the report, DRY MOUTH (her mouth felt like her teeth were rusting in her inner mouth, feels very dry and thicker), LIP DRY (Her lips are extremely dry and feel sore in the corners, they don't look swollen but they feel like it, they feel like they were exposed too much to the sun or wind) and FAECES DISCOLOURED (stool is very grainy or sandy and dark colored, like ash colored) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Vaccination site rash; Vaccination site pruritus; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PRURITUS (Vaccination site pruritus). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PRURITUS (Vaccination site pruritus) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment History was provided. No Concomitant medications were provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, SARS-CoV-2 test, SARS-CoV-2 test positive, Sinusitis
Clinical narrative: stuffy nose; cold; little bit of headache; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (stuffy nose), NASOPHARYNGITIS (cold), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and HEADACHE (little bit of headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On an unknown date, the patient experienced SINUSITIS (stuffy nose), NASOPHARYNGITIS (cold) and HEADACHE (little bit of headache). At the time of the report, SINUSITIS (stuffy nose), NASOPHARYNGITIS (cold), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and HEADACHE (little bit of headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Vaccination site pain
Clinical narrative: back pain; Vaccination site pain; This spontaneous case was reported by an other health care professional and describes the occurrence of BACK PAIN (back pain) and VACCINATION SITE PAIN (Vaccination site pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M020A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced BACK PAIN (back pain). The patient was treated with PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. On 08-Feb-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, BACK PAIN (back pain) 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 concomitants were reported.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Nasal congestion, Product dose omission issue
Clinical narrative: Missed second vaccination dose.; Tested positive for COVID-19; Stuffy nose; Lost sense of smell & taste; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second vaccination dose.), NASAL CONGESTION (Stuffy nose), AGEUSIA (Lost sense of smell & taste) and COVID-19 (Tested positive for COVID-19) 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) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced NASAL CONGESTION (Stuffy nose) and AGEUSIA (Lost sense of smell & taste). On 08-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second vaccination dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second vaccination dose.), NASAL CONGESTION (Stuffy nose), AGEUSIA (Lost sense of smell & taste) and COVID-19 (Tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported  No treatment information was provided    This case was linked to MOD-2021-035838, MOD-2021-035856, MOD-2021-036378 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: No specific follow-up information recorded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Heart rate, Heart rate increased
Clinical narrative: something in her throat; high pulse; heartbeat raised very fast; high blood pressure; panicking; lightheaded; very dizzy; felt like she was gonna faint; very nauseous; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (something in her throat), HEART RATE INCREASED (high pulse), HEART RATE INCREASED (heartbeat raised very fast), HYPERTENSION (high blood pressure) and PANIC REACTION (panicking) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (something in her throat), HEART RATE INCREASED (high pulse), HEART RATE INCREASED (heartbeat raised very fast), HYPERTENSION (high blood pressure), PANIC REACTION (panicking), DIZZINESS (lightheaded), DIZZINESS (very dizzy), DIZZINESS (felt like she was gonna faint), NAUSEA (very nauseous) and HEADACHE (very bad headache). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (something in her throat), HEART RATE INCREASED (high pulse), HEART RATE INCREASED (heartbeat raised very fast), HYPERTENSION (high blood pressure), PANIC REACTION (panicking), DIZZINESS (lightheaded), DIZZINESS (very dizzy), DIZZINESS (felt like she was gonna faint), NAUSEA (very nauseous) and HEADACHE (very bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) High. On an unknown date, Heart rate: increased (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants include Supplements, medicine for her thyroid. Just finished a breast cancer treatment.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Nausea, Oropharyngeal discomfort, Panic reaction
Clinical narrative: something in her throat; high pulse; heartbeat raised very fast; high blood pressure; panicking; lightheaded; very dizzy; felt like she was gonna faint; very nauseous; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (something in her throat), HEART RATE INCREASED (high pulse), HEART RATE INCREASED (heartbeat raised very fast), HYPERTENSION (high blood pressure) and PANIC REACTION (panicking) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (something in her throat), HEART RATE INCREASED (high pulse), HEART RATE INCREASED (heartbeat raised very fast), HYPERTENSION (high blood pressure), PANIC REACTION (panicking), DIZZINESS (lightheaded), DIZZINESS (very dizzy), DIZZINESS (felt like she was gonna faint), NAUSEA (very nauseous) and HEADACHE (very bad headache). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (something in her throat), HEART RATE INCREASED (high pulse), HEART RATE INCREASED (heartbeat raised very fast), HYPERTENSION (high blood pressure), PANIC REACTION (panicking), DIZZINESS (lightheaded), DIZZINESS (very dizzy), DIZZINESS (felt like she was gonna faint), NAUSEA (very nauseous) and HEADACHE (very bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) High. On an unknown date, Heart rate: increased (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants include Supplements, medicine for her thyroid. Just finished a breast cancer treatment.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Rhinorrhoea, Sneezing
Clinical narrative: Runny nose; Sneezing; Feeling cold; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (Runny nose), SNEEZING (Sneezing), FEELING COLD (Feeling cold) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Diabetes.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (Headache). On 04-Mar-2021, the patient experienced RHINORRHOEA (Runny nose), SNEEZING (Sneezing) and FEELING COLD (Feeling cold). At the time of the report, RHINORRHOEA (Runny nose), SNEEZING (Sneezing), FEELING COLD (Feeling cold) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications reported were Diabetic medication, Blood Pressure medications, Blood thinners ( drugs not specified- unknown indication). No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: erythema; vaccination site pruritus; vaccination site erythema; my arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE ERYTHEMA (vaccination site erythema), PAIN IN EXTREMITY (my arm got sore) and ERYTHEMA (erythema) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE ERYTHEMA (vaccination site erythema) and PAIN IN EXTREMITY (my arm got sore). On an unknown date, the patient experienced ERYTHEMA (erythema). At the time of the report, VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE ERYTHEMA (vaccination site erythema), PAIN IN EXTREMITY (my arm got sore) and ERYTHEMA (erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Sinusitis
Clinical narrative: sinusitis (allergies); pain at injection (left) arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinusitis (allergies)) and INJECTION SITE PAIN (pain at injection (left) arm) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection (left) arm). On 02-Mar-2021, the patient experienced SINUSITIS (sinusitis (allergies)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for Sinusitis, at an unspecified dose and frequency. On 14-Feb-2021, INJECTION SITE PAIN (pain at injection (left) arm) had resolved. At the time of the report, SINUSITIS (sinusitis (allergies)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea, Somnolence, Suspected COVID-19
Clinical narrative: felt like she was having COVID again; only wanted to sleep; exhausted; body hurt/she was very achy; very mild nausea; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (felt like she was having COVID again), SOMNOLENCE (only wanted to sleep), FATIGUE (exhausted), MYALGIA (body hurt/she was very achy) and NAUSEA (very mild nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient had COVID last July and spent five days in hospital.On December, she got tested and she still has antibodies.) in July 2020.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SUSPECTED COVID-19 (felt like she was having COVID again), SOMNOLENCE (only wanted to sleep), FATIGUE (exhausted), MYALGIA (body hurt/she was very achy) and NAUSEA (very mild nausea). On 02-Mar-2021, SUSPECTED COVID-19 (felt like she was having COVID again), SOMNOLENCE (only wanted to sleep), FATIGUE (exhausted), MYALGIA (body hurt/she was very achy) and NAUSEA (very mild nausea) 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.   Treatment information not provided. List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Non significant follow up received on 9-JUL-2021 and contains updated email id ,contact information and consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site pain
Clinical narrative: Am has a little bit of redness; Arm only bothers her when she lies on that side with a little soreness; Vaccination site Discoloration; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Am has a little bit of redness), VACCINATION SITE PAIN (Arm only bothers her when she lies on that side with a little soreness) and VACCINATION SITE DISCOLOURATION (Vaccination site Discoloration) 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Am has a little bit of redness), VACCINATION SITE PAIN (Arm only bothers her when she lies on that side with a little soreness) and VACCINATION SITE DISCOLOURATION (Vaccination site Discoloration). At the time of the report, VACCINATION SITE ERYTHEMA (Am has a little bit of redness), VACCINATION SITE PAIN (Arm only bothers her when she lies on that side with a little soreness) and VACCINATION SITE DISCOLOURATION (Vaccination site Discoloration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: Herpes (outbreak 1, outbreak 2, outbreak 3, outbreak 4); This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (Herpes (outbreak 1, outbreak 2, outbreak 3, outbreak 4)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Herpes infection.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced HERPES VIRUS INFECTION (Herpes (outbreak 1, outbreak 2, outbreak 3, outbreak 4)). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes infection, at a dose of 500 milligram. At the time of the report, HERPES VIRUS INFECTION (Herpes (outbreak 1, outbreak 2, outbreak 3, outbreak 4)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       List of concomitant medication were not given.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Nasal congestion, Nasopharyngitis
Clinical narrative: Cold symptom; Congestion; exposed to individual with COVID virus; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptom), NASAL CONGESTION (Congestion) and EXPOSURE TO SARS-COV-2 (exposed to individual with COVID virus) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold symptom), NASAL CONGESTION (Congestion) and EXPOSURE TO SARS-COV-2 (exposed to individual with COVID virus). At the time of the report, NASOPHARYNGITIS (Cold symptom), NASAL CONGESTION (Congestion) and EXPOSURE TO SARS-COV-2 (exposed to individual with COVID virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   It was reported that, patient woke up to cold symptoms and congestion. She found out that her son-in-law was diagnosed with Covid on 03-Mar-2021. She has been exposed to son-in-law over the last few days and a lot of people at her husband's employer have Covid. She had cold symptoms and congestion and was not sure if she herself had COVID.  No corrective treatment was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Mass, Pain in extremity
Clinical narrative: Lump between shoulder and neck on both sides; Tired/sleepy; Arm pain; Dry mouth; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), FATIGUE (Tired/sleepy), PAIN IN EXTREMITY (Arm pain) and MASS (Lump between shoulder and neck on both sides) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DRY MOUTH (Dry mouth) and PAIN IN EXTREMITY (Arm pain). On 27-Feb-2021, the patient experienced FATIGUE (Tired/sleepy). On 03-Mar-2021, the patient experienced MASS (Lump between shoulder and neck on both sides). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 27-Feb-2021, DRY MOUTH (Dry mouth), FATIGUE (Tired/sleepy) and PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, MASS (Lump between shoulder and neck on both sides) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include, Blood Pressure medication.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Hyperhidrosis, Pyrexia
Clinical narrative: sweat; fever (100 ° F); chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweat), PYREXIA (fever (100 ° F)) and CHILLS (chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPERHIDROSIS (sweat), PYREXIA (fever (100 ° F)) and CHILLS (chills). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HYPERHIDROSIS (sweat), PYREXIA (fever (100 ° F)) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 100 (High) 100° F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second Shot not Received placing ouside the 36 day window; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second Shot not Received placing ouside the 36 day window) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Dec-2020, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second Shot not Received placing ouside the 36 day window). On 05-Dec-2020, PRODUCT DOSE OMISSION ISSUE (Second Shot not Received placing ouside the 36 day window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. No treatment information was provided.; Sender's Comments: This report refers to a case of Product Dose Omission Issue for mRNA-1273  with no associated AEs.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pruritus, Rash pruritic
Clinical narrative: Itchy rash on both arms; Scratching it so much that her skin has started to bleed; Exacerbated my fatigue; Arm was sore for several days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore for several days), RASH PRURITIC (Itchy rash on both arms), PRURITUS (Scratching it so much that her skin has started to bleed) and FATIGUE (Exacerbated my fatigue) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 032H20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), PRAMIPEXOLE, OMEPRAZOLE, OLMESARTAN MEDOXOMIL (BENICAR), AMLODIPINE, DENOSUMAB (PROLIA), STRONTIUM, SELENIUM, MACROGOL 3350 (MIRALAX), ACETAMINOPHEN, CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]), VITAMIN C [ASCORBIC ACID], BIOTIN, MAGNESIUM, KRILL OIL, MENAQUINONE-7 (MK 7 [MENAQUINONE-7]) and ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY [ASCORBIC ACID;VACCINIUM MACROCARPON]) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore for several days) and FATIGUE (Exacerbated my fatigue). On 03-Mar-2021, the patient experienced PRURITUS (Scratching it so much that her skin has started to bleed). On an unknown date, the patient experienced RASH PRURITIC (Itchy rash on both arms). The patient was treated with SILVER (COLLOIDAL SILVER) for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Arm was sore for several days), RASH PRURITIC (Itchy rash on both arms), PRURITUS (Scratching it so much that her skin has started to bleed) and FATIGUE (Exacerbated my fatigue) outcome was unknown.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Movement disorder, Nasopharyngitis, Pain in extremity
Clinical narrative: arm was very sore; hard to lift; felt very unwell; lightheaded; very cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore), MOVEMENT DISORDER (hard to lift), MALAISE (felt very unwell), DIZZINESS (lightheaded) and NASOPHARYNGITIS (very cold) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was very sore), MOVEMENT DISORDER (hard to lift), MALAISE (felt very unwell), DIZZINESS (lightheaded) and NASOPHARYNGITIS (very cold). At the time of the report, PAIN IN EXTREMITY (arm was very sore), MOVEMENT DISORDER (hard to lift), MALAISE (felt very unwell), DIZZINESS (lightheaded) and NASOPHARYNGITIS (very cold) outcome was unknown.            No concomitant medications were reported.  Treatment medications included Ibuprofen Motrin 200 mg.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Splitting headache; Fever of 99.8; Chills; Muscle Soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Splitting headache), PYREXIA (Fever of 99.8), CHILLS (Chills) and MYALGIA (Muscle Soreness) in a male 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 in May 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Splitting headache), PYREXIA (Fever of 99.8), CHILLS (Chills) and MYALGIA (Muscle Soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, HEADACHE (Splitting headache), PYREXIA (Fever of 99.8), CHILLS (Chills) and MYALGIA (Muscle Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       List of concomitant medication were not given.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhea) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 015M20A) 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) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On 04-Mar-2021, DIARRHOEA (Diarrhea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-016273
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Memory impairment, Pain, Pyrexia
Clinical narrative: Shaking; General aches and pain; Hard to remember things; Severe tremors/vaccine has made it worse; Fever; Headache/ mild headache; Alternating fever and chills; Chills/ chills were so bad that her husband had to hold he glass for her to drink; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), PAIN (General aches and pain), MEMORY IMPAIRMENT (Hard to remember things), TREMOR (Severe tremors/vaccine has made it worse) and PYREXIA (Fever) in a 78-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 Familial tremor (Patient states she has non-essential/familial tremor which she has had for 20 years). Concomitant products included PROBIOTICS NOS, AMINOBENZOIC ACID, BIOTIN, CHOLINE BITARTRATE, FOLIC ACID, INOSITOL, LECITHIN, VITAMIN B NOS (B100), CALCIUM CITRATE, COLECALCIFEROL (CITRICAL D), FAMOTIDINE, FOLIC ACID, GABAPENTIN, LEVOTHYROXINE, MELATONIN, OXYBUTYNIN, PRIMIDONE, PROPRANOLOL, TOPIRAMATE, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), VITAMIN B1 NOS and VITAMIN D3 for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking), PAIN (General aches and pain), MEMORY IMPAIRMENT (Hard to remember things), TREMOR (Severe tremors/vaccine has made it worse), PYREXIA (Fever), CHILLS (Chills/ chills were so bad that her husband had to hold he glass for her to drink), HEADACHE (Headache/ mild headache) and PYREXIA (Alternating fever and chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) for Headache and Fever, at a dose of UNK dosage form; PARACETAMOL (TYLENOL) for Pain, Fever and Headache, at a dose of UNK dosage form and TRAMADOL for Pain, at a dose of UNK dosage form. At the time of the report, TREMOR (Shaking), PAIN (General aches and pain), MEMORY IMPAIRMENT (Hard to remember things), TREMOR (Severe tremors/vaccine has made it worse), PYREXIA (Fever), CHILLS (Chills/ chills were so bad that her husband had to hold he glass for her to drink), HEADACHE (Headache/ mild headache) and PYREXIA (Alternating fever and chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Shaking; General aches and pain; Hard to remember things; Severe tremors/vaccine has made it worse; Fever; Headache/ mild headache; Alternating fever and chills; Chills/ chills were so bad that her husband had to hold he glass for her to drink; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), PAIN (General aches and pain), MEMORY IMPAIRMENT (Hard to remember things), TREMOR (Severe tremors/vaccine has made it worse) and PYREXIA (Fever) in a 78-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 Familial tremor (Patient states she has non-essential/familial tremor which she has had for 20 years). Concomitant products included PROBIOTICS NOS, AMINOBENZOIC ACID, BIOTIN, CHOLINE BITARTRATE, FOLIC ACID, INOSITOL, LECITHIN, VITAMIN B NOS (B100), CALCIUM CITRATE, COLECALCIFEROL (CITRICAL D), FAMOTIDINE, FOLIC ACID, GABAPENTIN, LEVOTHYROXINE, MELATONIN, OXYBUTYNIN, PRIMIDONE, PROPRANOLOL, TOPIRAMATE, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL), VITAMIN B1 NOS and VITAMIN D3 for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking), PAIN (General aches and pain), MEMORY IMPAIRMENT (Hard to remember things), TREMOR (Severe tremors/vaccine has made it worse), PYREXIA (Fever), CHILLS (Chills/ chills were so bad that her husband had to hold he glass for her to drink), HEADACHE (Headache/ mild headache) and PYREXIA (Alternating fever and chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) for Headache and Fever, at a dose of UNK dosage form; PARACETAMOL (TYLENOL) for Pain, Fever and Headache, at a dose of UNK dosage form and TRAMADOL for Pain, at a dose of UNK dosage form. At the time of the report, TREMOR (Shaking), PAIN (General aches and pain), MEMORY IMPAIRMENT (Hard to remember things), TREMOR (Severe tremors/vaccine has made it worse), PYREXIA (Fever), CHILLS (Chills/ chills were so bad that her husband had to hold he glass for her to drink), HEADACHE (Headache/ mild headache) and PYREXIA (Alternating fever and chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Heard a rumor that they have received expired vaccines; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Heard a rumor that they have received expired vaccines) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Heard a rumor that they have received expired vaccines). On 29-Jan-2021, EXPIRED PRODUCT ADMINISTERED (Heard a rumor that they have received expired vaccines) had resolved.            No concomitant medications were reported.   No corrective treatment was provided.   This case was linked to MOD-2021-035882, MOD-2021-035855, MOD-2021-035873 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: No new information was received.; Sender's Comments: This report refers to a case of expired product used in a 73 year old female with no associated AEs. MOD-2021-035882:Patient's First Dose MOD-2021-035855:Husband's First Dose MOD-2021-035873:Husband's Second Dose
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound scan
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 36-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Gestational hypertension (June7-2017 gestational hypertension- induced ,15-Mar-2019 -gestational hypertension.), C-section (Live-full-term birth) on 07-Jun-2017 and C-section (Live-full-term birth) on 15-Mar-2019. Concurrent medical conditions included Anxiety. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, FISH OIL for Prenatal care.    On 02-Mar-2021 at 4:00 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 12-Nov-2020 and the estimated date of delivery was 19-Aug-2021. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth 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. On 02-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2020, Pregnancy test: positive (Positive) Positive. In January 2021, Prenatal screening test: negative (Negative) Negative. On 04-Feb-2021, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Estimated date of conception was reported as 26-Nov-2020. There was no maternal history of subfertility and had established prenatal care.