chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Neck pain, Panic attack, Paraesthesia
Clinical narrative: can't be stand for too long because start feeling malaise, she only can be lying down; intense pressure on her back head; Intense pressure on her neck; Sometimes feels like pins sticking on head; Dizziness; Panic attack in the night; Isn't able to sleep; Feeling malaise; still have strong headache/ did some exercise and on the afternoon she get up and felt a strong headache/ this headache doesn't go away; felt like I was going to die; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like I was going to die), DYSSTASIA (can't be stand for too long because start feeling malaise, she only can be lying down), HEAD DISCOMFORT (intense pressure on her back head), NECK PAIN (Intense pressure on her neck) and PARAESTHESIA (Sometimes feels like pins sticking on head) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety disorder (treatment with natural things).    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced FEELING ABNORMAL (felt like I was going to die) and HEADACHE (still have strong headache/ did some exercise and on the afternoon she get up and felt a strong headache/ this headache doesn't go away). On an unknown date, the patient experienced DYSSTASIA (can't be stand for too long because start feeling malaise, she only can be lying down), HEAD DISCOMFORT (intense pressure on her back head), NECK PAIN (Intense pressure on her neck), PARAESTHESIA (Sometimes feels like pins sticking on head), DIZZINESS (Dizziness), PANIC ATTACK (Panic attack in the night), INSOMNIA (Isn't able to sleep) and MALAISE (Feeling malaise). The patient was treated with PARACETAMOL (TYLENOL) 03-Aug-2021 for Headache, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt like I was going to die), DYSSTASIA (can't be stand for too long because start feeling malaise, she only can be lying down), HEAD DISCOMFORT (intense pressure on her back head), NECK PAIN (Intense pressure on her neck), PARAESTHESIA (Sometimes feels like pins sticking on head), DIZZINESS (Dizziness), PANIC ATTACK (Panic attack in the night), INSOMNIA (Isn't able to sleep) and MALAISE (Feeling malaise) outcome was unknown and HEADACHE (still have strong headache/ did some exercise and on the afternoon she get up and felt a strong headache/ this headache doesn't go away) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    No concomitant medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received included information about patient demographics, additional events, other relevant history, dose 1 details  and treatment medication was added to the case.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pruritus, Vaccination site hypoaesthesia
Clinical narrative: numbness in her right thigh/outside of her right thigh got very numb; the area where she got the shot got very numb; itching all throughout her body/then itching started/the right side of her body is itching; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in her right thigh/outside of her right thigh got very numb), PRURITUS (itching all throughout her body/then itching started/the right side of her body is itching) and VACCINATION SITE HYPOAESTHESIA (the area where she got the shot got very numb) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053L21A and 053L21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), TOPIRAMATE (TOPAMAX), CLONIDINE and GABAPENTIN for an unknown indication.   On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced HYPOAESTHESIA (numbness in her right thigh/outside of her right thigh got very numb) and VACCINATION SITE HYPOAESTHESIA (the area where she got the shot got very numb). In July 2021, the patient experienced PRURITUS (itching all throughout her body/then itching started/the right side of her body is itching). At the time of the report, HYPOAESTHESIA (numbness in her right thigh/outside of her right thigh got very numb) and VACCINATION SITE HYPOAESTHESIA (the area where she got the shot got very numb) had resolved and PRURITUS (itching all throughout her body/then itching started/the right side of her body is itching) outcome was unknown.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant follow up - patient demographics, concomitant drugs, 2 doses details, Event added .
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea, Hyperhidrosis, Muscle tightness, Pyrexia
Clinical narrative: Heart flutter; Tightness in neck; Hard time Breathing; Excessive sweating; Local swelling; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of CARDIAC FLUTTER (Heart flutter) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart flutter) (seriousness criterion medically significant), MUSCLE TIGHTNESS (Tightness in neck), DYSPNOEA (Hard time Breathing), HYPERHIDROSIS (Excessive sweating), SWELLING (Local swelling) and PYREXIA (Fever). At the time of the report, CARDIAC FLUTTER (Heart flutter), MUSCLE TIGHTNESS (Tightness in neck), DYSPNOEA (Hard time Breathing), HYPERHIDROSIS (Excessive sweating), SWELLING (Local swelling) and PYREXIA (Fever) 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 concomitant medication was provided. Treatment information was not provided. It was reported that symptoms were better during the day, some symptoms worsen again while relaxing 8/4.  Company Comment: 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.; 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Heart flutter; Tightness in neck; Hard time Breathing; Excessive sweating; Local swelling; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of CARDIAC FLUTTER (Heart flutter) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart flutter) (seriousness criterion medically significant), MUSCLE TIGHTNESS (Tightness in neck), DYSPNOEA (Hard time Breathing), HYPERHIDROSIS (Excessive sweating), SWELLING (Local swelling) and PYREXIA (Fever). At the time of the report, CARDIAC FLUTTER (Heart flutter), MUSCLE TIGHTNESS (Tightness in neck), DYSPNOEA (Hard time Breathing), HYPERHIDROSIS (Excessive sweating), SWELLING (Local swelling) and PYREXIA (Fever) 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 concomitant medication was provided. Treatment information was not provided. It was reported that symptoms were better during the day, some symptoms worsen again while relaxing 8/4.  Company Comment: 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.; 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.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test, Sinus disorder, Throat irritation, Upper respiratory tract infection
Clinical narrative: Scratchy throat; Cough; Sinus problems; Felt like upper respiratory infection; Sore arm for a couple of days after both doses; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy throat), COUGH (Cough), SINUS DISORDER (Sinus problems), UPPER RESPIRATORY TRACT INFECTION (Felt like upper respiratory infection) and VACCINATION SITE PAIN (Sore arm for a couple of days after both doses) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included VITAMINS NOS for Blood pressure high.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Scratchy throat), COUGH (Cough), SINUS DISORDER (Sinus problems), UPPER RESPIRATORY TRACT INFECTION (Felt like upper respiratory infection) and VACCINATION SITE PAIN (Sore arm for a couple of days after both doses). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, THROAT IRRITATION (Scratchy throat), COUGH (Cough), SINUS DISORDER (Sinus problems), UPPER RESPIRATORY TRACT INFECTION (Felt like upper respiratory infection) and VACCINATION SITE PAIN (Sore arm for a couple of days after both doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medications include daily blood pressure medicine.   This case was linked to MOD-2021-280584 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Scratchy throat; Cough; Sinus problems; Felt like upper respiratory infection; Sore arm for a couple of days after both doses; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy throat), COUGH (Cough), SINUS DISORDER (Sinus problems), UPPER RESPIRATORY TRACT INFECTION (Felt like upper respiratory infection) and VACCINATION SITE PAIN (Sore arm for a couple of days after both doses) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included VITAMINS NOS for Blood pressure high.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Scratchy throat), COUGH (Cough), SINUS DISORDER (Sinus problems), UPPER RESPIRATORY TRACT INFECTION (Felt like upper respiratory infection) and VACCINATION SITE PAIN (Sore arm for a couple of days after both doses). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, THROAT IRRITATION (Scratchy throat), COUGH (Cough), SINUS DISORDER (Sinus problems), UPPER RESPIRATORY TRACT INFECTION (Felt like upper respiratory infection) and VACCINATION SITE PAIN (Sore arm for a couple of days after both doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medications include daily blood pressure medicine.   This case was linked to MOD-2021-280584 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got COVID-19 again, but with no symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID-19 again, but with no symptoms) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced COVID-19 (got COVID-19 again, but with no symptoms). At the time of the report, COVID-19 (got COVID-19 again, but with no symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2021, SARS-CoV-2 test: negative (Negative) negative COVID test.         No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up information received and added lab data.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received his first Moderna dose in January, did not have second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received his first Moderna dose in January, did not have second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received his first Moderna dose in January, did not have second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received his first Moderna dose in January, did not have second dose) had resolved.        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 Concomitant medications were provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow-up information received and contains No new information.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: soreness; Tiredness; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (soreness) and FATIGUE (Tiredness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (Allergic to shrimp), Drug allergy (Cold medications) and Blood pressure inadequately controlled.   In February 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness) and FATIGUE (Tiredness). At the time of the report, MYALGIA (soreness) and FATIGUE (Tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was on blood pressure medications.  No treatment information was reported.   This case was linked to MOD-2021-280936 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: prefilled syringes were stored at room temperature between 60-73F; administered with the vaccine from prefilled syringe prepared last 06Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from prefilled syringe prepared last 06Aug2021) and PRODUCT STORAGE ERROR (prefilled syringes were stored at room temperature between 60-73F) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00186502 and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from prefilled syringe prepared last 06Aug2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (prefilled syringes were stored at room temperature between 60-73F). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine from prefilled syringe prepared last 06Aug2021) and PRODUCT STORAGE ERROR (prefilled syringes were stored at room temperature between 60-73F) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received and contain non significant information.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Illness, Malaise, Menstruation irregular, Nausea
Clinical narrative: irregular period (had it 2x in one month); very strong/heavy period; extremely sick; not feeling good; sore arm/pain in arm; low grade fever; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of MENSTRUATION IRREGULAR (irregular period (had it 2x in one month)), HEAVY MENSTRUAL BLEEDING (very strong/heavy period), ILLNESS (extremely sick), MALAISE (not feeling good) and VACCINATION SITE PAIN (sore arm/pain in arm) in a 51-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.     Concurrent medical conditions included Food allergy (Allergic to shrimps.), Drug allergy (Allergic to cold medications) and Blood pressure inadequately controlled.   In February 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (irregular period (had it 2x in one month)), HEAVY MENSTRUAL BLEEDING (very strong/heavy period), ILLNESS (extremely sick), MALAISE (not feeling good), VACCINATION SITE PAIN (sore arm/pain in arm), PYREXIA (low grade fever) and NAUSEA (Nausea). At the time of the report, MENSTRUATION IRREGULAR (irregular period (had it 2x in one month)), HEAVY MENSTRUAL BLEEDING (very strong/heavy period), ILLNESS (extremely sick), MALAISE (not feeling good), VACCINATION SITE PAIN (sore arm/pain in arm), PYREXIA (low grade fever) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was on blood pressure medications.  No treatment information was reported.   This case was linked to MOD-2021-280917 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: irregular period (had it 2x in one month); very strong/heavy period; extremely sick; not feeling good; sore arm/pain in arm; low grade fever; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of MENSTRUATION IRREGULAR (irregular period (had it 2x in one month)), HEAVY MENSTRUAL BLEEDING (very strong/heavy period), ILLNESS (extremely sick), MALAISE (not feeling good) and VACCINATION SITE PAIN (sore arm/pain in arm) in a 51-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.     Concurrent medical conditions included Food allergy (Allergic to shrimps.), Drug allergy (Allergic to cold medications) and Blood pressure inadequately controlled.   In February 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (irregular period (had it 2x in one month)), HEAVY MENSTRUAL BLEEDING (very strong/heavy period), ILLNESS (extremely sick), MALAISE (not feeling good), VACCINATION SITE PAIN (sore arm/pain in arm), PYREXIA (low grade fever) and NAUSEA (Nausea). At the time of the report, MENSTRUATION IRREGULAR (irregular period (had it 2x in one month)), HEAVY MENSTRUAL BLEEDING (very strong/heavy period), ILLNESS (extremely sick), MALAISE (not feeling good), VACCINATION SITE PAIN (sore arm/pain in arm), PYREXIA (low grade fever) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was on blood pressure medications.  No treatment information was reported.   This case was linked to MOD-2021-280917 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Dizziness, Headache
Clinical narrative: dizzy spell/ dizziness is really bad; eyes were a little strained; headache/ little headache from forehead to nose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spell/ dizziness is really bad), ASTHENOPIA (eyes were a little strained) and HEADACHE (headache/ little headache from forehead to nose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced DIZZINESS (dizzy spell/ dizziness is really bad), ASTHENOPIA (eyes were a little strained) and HEADACHE (headache/ little headache from forehead to nose). At the time of the report, DIZZINESS (dizzy spell/ dizziness is really bad), ASTHENOPIA (eyes were a little strained) and HEADACHE (headache/ little headache from forehead to nose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported Treatment information was not reported
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation delayed, Muscle spasms, Ovulation disorder
Clinical narrative: late period since 2nd dose; heavy period; affected ovulation; started to have cramps; a few days ago she had spotting; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (late period since 2nd dose), HEAVY MENSTRUAL BLEEDING (heavy period), OVULATION DISORDER (affected ovulation), MUSCLE SPASMS (started to have cramps) and INTERMENSTRUAL BLEEDING (a few days ago she had spotting) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (Patient had planned both her pregnancies before and was unlikely that she miscalculated her ovulation) and Depression (Patient takes a newly FDA-approved medication for her severe depression.). Concomitant products included KETAMINE, ESCITALOPRAM OXALATE (LEXAPRO), ALPRAZOLAM (XANAX), GABAPENTIN, AMFETAMINE (AMPHETAMINE) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced OVULATION DISORDER (affected ovulation), MUSCLE SPASMS (started to have cramps) and INTERMENSTRUAL BLEEDING (a few days ago she had spotting). On an unknown date, the patient experienced MENSTRUATION DELAYED (late period since 2nd dose) and HEAVY MENSTRUAL BLEEDING (heavy period). At the time of the report, MENSTRUATION DELAYED (late period since 2nd dose), HEAVY MENSTRUAL BLEEDING (heavy period), OVULATION DISORDER (affected ovulation), MUSCLE SPASMS (started to have cramps) and INTERMENSTRUAL BLEEDING (a few days ago she had spotting) outcome was unknown.            No treatment medications were reported. The patient would be taking a pregnancy test soon.   This case was linked to MOD-2021-281053 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Some facial numbness; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (Some facial numbness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Some facial numbness). At the time of the report, HYPOAESTHESIA (Some facial numbness) 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 concomitant medications are provided by reporter. No treatment medications are provided by reporter.   Reporter did not allow further contact
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) had resolved.        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 concomitant products were reported. No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Additional information was received and primary reporter's details updated and event description updated. On 11-Aug-2021: Additional information was received and primary reporter's details updated.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Eexperienced fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Eexperienced fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression (She was taking a newly FDA-approved medication for severe depression) and Suspected pregnancy. Concomitant products included KETAMINE, ESCITALOPRAM OXALATE (LEXAPRO), ALPRAZOLAM (XANAX), GABAPENTIN, AMPHETAMINE and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 01-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 FATIGUE (Eexperienced fatigue). At the time of the report, FATIGUE (Eexperienced fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drugs were not provided. The patient reported that she will be taking a pregnancy test. Se also reported that she is taking a newly FDA-approved medication for severe depression   This case was linked to MOD-2021-281006 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Fatigue, Influenza like illness
Clinical narrative: tired; passed out; very very sick; felt like she had a bad flu; bad aches in her bones; bad aches in her joints; Her temperature was 100.3 °F; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 9:00 PM, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), VACCINATION COMPLICATION (very very sick), INFLUENZA LIKE ILLNESS (felt like she had a bad flu), BONE PAIN (bad aches in her bones), ARTHRALGIA (bad aches in her joints) and PYREXIA (Her temperature was 100.3 °F). On 22-Apr-2021, the patient experienced FATIGUE (tired). On 22-Apr-2021, LOSS OF CONSCIOUSNESS (passed out), VACCINATION COMPLICATION (very very sick), INFLUENZA LIKE ILLNESS (felt like she had a bad flu), BONE PAIN (bad aches in her bones), ARTHRALGIA (bad aches in her joints) and PYREXIA (Her temperature was 100.3 °F) had resolved. At the time of the report, FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100 (High) 100.3 °F.         No concomitant medication details was provided. No treatment medication details was provided.  She was vaccinated both times in the same facility.  Company Comment  : 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. Further information has been requested.   This case was linked to MOD-2021-060799 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pyrexia, Vaccination complication
Clinical narrative: tired; passed out; very very sick; felt like she had a bad flu; bad aches in her bones; bad aches in her joints; Her temperature was 100.3 °F; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 9:00 PM, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), VACCINATION COMPLICATION (very very sick), INFLUENZA LIKE ILLNESS (felt like she had a bad flu), BONE PAIN (bad aches in her bones), ARTHRALGIA (bad aches in her joints) and PYREXIA (Her temperature was 100.3 °F). On 22-Apr-2021, the patient experienced FATIGUE (tired). On 22-Apr-2021, LOSS OF CONSCIOUSNESS (passed out), VACCINATION COMPLICATION (very very sick), INFLUENZA LIKE ILLNESS (felt like she had a bad flu), BONE PAIN (bad aches in her bones), ARTHRALGIA (bad aches in her joints) and PYREXIA (Her temperature was 100.3 °F) had resolved. At the time of the report, FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 100 (High) 100.3 °F.         No concomitant medication details was provided. No treatment medication details was provided.  She was vaccinated both times in the same facility.  Company Comment  : 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. Further information has been requested.   This case was linked to MOD-2021-060799 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), MYALGIA (Body aches), FATIGUE (Tiredness) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), MYALGIA (Body aches), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, DECREASED APPETITE (Loss of appetite), MYALGIA (Body aches), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: It was very itchy; Had a rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (It was very itchy) and RASH (Had a rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (It was very itchy) and RASH (Had a rash). At the time of the report, PRURITUS (It was very itchy) and RASH (Had a rash) 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.   Concomitant medications were not reported.   No treatment medication was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: some side effects after first dose; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (some side effects after first dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (some side effects after first dose). At the time of the report, VACCINATION COMPLICATION (some side effects after first dose) 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 concomitant medications were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-281160 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Back pain, Chest discomfort, Chest pain
Clinical narrative: Back ache; Stomach ache; Weakness; Sharp chest pain; chest pressure/chest tightness; Chills; Headache / bad headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back ache), ABDOMINAL PAIN UPPER (Stomach ache), ASTHENIA (Weakness), CHEST PAIN (Sharp chest pain) and CHEST DISCOMFORT (chest pressure/chest tightness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced HEADACHE (Headache / bad headache). On 07-Aug-2021, the patient experienced BACK PAIN (Back ache), ABDOMINAL PAIN UPPER (Stomach ache), ASTHENIA (Weakness), CHEST PAIN (Sharp chest pain), CHEST DISCOMFORT (chest pressure/chest tightness) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 08-Aug-2021, BACK PAIN (Back ache), ABDOMINAL PAIN UPPER (Stomach ache), ASTHENIA (Weakness), HEADACHE (Headache / bad headache) and CHILLS (Chills) had resolved. At the time of the report, CHEST PAIN (Sharp chest pain) and CHEST DISCOMFORT (chest pressure/chest tightness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up contains as reported of chest pressure updated.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Back ache; Stomach ache; Weakness; Sharp chest pain; chest pressure/chest tightness; Chills; Headache / bad headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back ache), ABDOMINAL PAIN UPPER (Stomach ache), ASTHENIA (Weakness), CHEST PAIN (Sharp chest pain) and CHEST DISCOMFORT (chest pressure/chest tightness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced HEADACHE (Headache / bad headache). On 07-Aug-2021, the patient experienced BACK PAIN (Back ache), ABDOMINAL PAIN UPPER (Stomach ache), ASTHENIA (Weakness), CHEST PAIN (Sharp chest pain), CHEST DISCOMFORT (chest pressure/chest tightness) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 08-Aug-2021, BACK PAIN (Back ache), ABDOMINAL PAIN UPPER (Stomach ache), ASTHENIA (Weakness), HEADACHE (Headache / bad headache) and CHILLS (Chills) had resolved. At the time of the report, CHEST PAIN (Sharp chest pain) and CHEST DISCOMFORT (chest pressure/chest tightness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up contains as reported of chest pressure updated.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: seven months pregnant now; arm soreness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (seven months pregnant now) and PAIN IN EXTREMITY (arm soreness) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 16-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-Jan-2021 and the estimated date of delivery was 18-Oct-2021. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (seven months pregnant now). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 16-Jan-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (seven months pregnant now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to (Patient Link).; Sender's Comments: This is a case of Exposure during pregnancy with associated adverse event for this 31-year-old female patient. Patient will continue to be contacted for further monitoring of AE during the pregnancy. Considering currently available information and plausible temporal association between product use and onset of associated event, causal role cannot be excluded and thus, causality for Pain in extremity is assessed as possibly related.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eye pain, Headache
Clinical narrative: Horrific pain behind my right eye; Shortly thereafter I started getting hedaches and a horrific pain behind my right eye, which keeps getting worse; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Horrific pain behind my right eye), CONDITION AGGRAVATED (Shortly thereafter I started getting hedaches and a horrific pain behind my right eye, which keeps getting worse) and HEADACHE (Headaches) 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.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced EYE PAIN (Horrific pain behind my right eye), CONDITION AGGRAVATED (Shortly thereafter I started getting hedaches and a horrific pain behind my right eye, which keeps getting worse) and HEADACHE (Headaches). At the time of the report, EYE PAIN (Horrific pain behind my right eye), CONDITION AGGRAVATED (Shortly thereafter I started getting hedaches and a horrific pain behind my right eye, which keeps getting worse) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue, Maternal exposure during pregnancy, Pregnancy, Product dose omission issue
Clinical narrative: Vaccine exposure during pregnancy; pregnancy; 5 weeks pregnant but in need of her second dose; 1st dose of the vaccine given on an unspecified date in May or June 2021; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given on an unspecified date in May or June 2021), PREGNANCY (pregnancy) and INTENTIONAL PRODUCT USE ISSUE (5 weeks pregnant but in need of her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 30-Jun-2021 and the estimated date of delivery was 06-Apr-2022. On 09-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given on an unspecified date in May or June 2021). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PREGNANCY (pregnancy) and INTENTIONAL PRODUCT USE ISSUE (5 weeks pregnant but in need of her second dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given on an unspecified date in May or June 2021) and PREGNANCY (pregnancy) had resolved and INTENTIONAL PRODUCT USE ISSUE (5 weeks pregnant but in need of her second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up information included  new event