chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021A21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 06-Mar-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 01-Jul-2020 and the estimated date of delivery was 08-Apr-2021. On 06-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were  reported. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Induration, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: itching; really hard; 101.7° temperature; arm swollen; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (soreness), PRURITUS (itching), INDURATION (really hard) and PYREXIA (101.7° temperature) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. d06M2074) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swollen) and PAIN IN EXTREMITY (soreness). On 10-Mar-2021, the patient experienced PRURITUS (itching), INDURATION (really hard) and PYREXIA (101.7° temperature). On 11-Mar-2021, PRURITUS (itching), INDURATION (really hard) and PYREXIA (101.7° temperature) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swollen) had not resolved and PAIN IN EXTREMITY (soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.7 (High) 101.7.         No relevant concomitant medications were reported.  No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: itching; really hard; 101.7° temperature; arm swollen; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (soreness), PRURITUS (itching), INDURATION (really hard) and PYREXIA (101.7° temperature) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. d06M2074) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swollen) and PAIN IN EXTREMITY (soreness). On 10-Mar-2021, the patient experienced PRURITUS (itching), INDURATION (really hard) and PYREXIA (101.7° temperature). On 11-Mar-2021, PRURITUS (itching), INDURATION (really hard) and PYREXIA (101.7° temperature) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swollen) had not resolved and PAIN IN EXTREMITY (soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.7 (High) 101.7.         No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting all night; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting all night) 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 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VOMITING (vomiting all night). At the time of the report, VOMITING (vomiting all night) was resolving. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red, very itchy noticeable rash on her arm), PRURITUS (red, very itchy noticeable rash on her arm) and RASH (red, very itchy noticeable rash on her arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The patient's past medical history included Scleroderma, Raynaud's syndrome and Connective tissue disorder (Interstitial). Concurrent medical conditions included Latex allergy, Dust allergy and Pollen allergy (tree). Concomitant products included METHOTREXATE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) and ARGININE for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ERYTHEMA (red, very itchy noticeable rash on her arm), PRURITUS (red, very itchy noticeable rash on her arm) and RASH (red, very itchy noticeable rash on her arm). At the time of the report, ERYTHEMA (red, very itchy noticeable rash on her arm), PRURITUS (red, very itchy noticeable rash on her arm) and RASH (red, very itchy noticeable rash on her arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia, Vaccination site pain, Vaccination site rash
Clinical narrative: rash at injection site; feverish; remained in bed sleeping on and off; left arm was sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (remained in bed sleeping on and off), VACCINATION SITE PAIN (left arm was sore at injection site), VACCINATION SITE RASH (rash at injection site) and PYREXIA (feverish) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01021A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disorder. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) and ASA for an unknown indication.   On 28-Feb-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced MALAISE (remained in bed sleeping on and off). 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm was sore at injection site). On 29-Mar-2021, the patient experienced PYREXIA (feverish). On 30-Mar-2021, the patient experienced VACCINATION SITE RASH (rash at injection site). On 29-Mar-2021, PYREXIA (feverish) had resolved. At the time of the report, MALAISE (remained in bed sleeping on and off), VACCINATION SITE PAIN (left arm was sore at injection site) and VACCINATION SITE RASH (rash at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: 101 (abnormal) Fahrenheit Feverish and 98.6 (normal) Fahrenheit  end of the day normal.         Additional concomitant medication includes statins, heart medication and diabetic medication multi vitamin.  There were not further specified in initial source document.  treatment information was not provided   Treatment information was not reported.   This case was linked to MOD-2021-041102.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: added patient demographic details new lab data. added new events pyrexia malaise and injection site rash
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Vaccination site rash
Clinical narrative: Cold to Hot Sensation Going Up and Down the Arm; Fatigue; Chills; a Rash Near the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Cold to Hot Sensation Going Up and Down the Arm), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE RASH (a Rash Near the Injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    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 FEELING OF BODY TEMPERATURE CHANGE (Cold to Hot Sensation Going Up and Down the Arm), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE RASH (a Rash Near the Injection site). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Cold to Hot Sensation Going Up and Down the Arm), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE RASH (a Rash Near the Injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Dysphagia, Oropharyngeal pain, Throat tightness
Clinical narrative: Hard time going down, almost felt like it was restricted; during the night very dry throat; very sore throat; Almost felt it was closing up; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (during the night very dry throat), OROPHARYNGEAL PAIN (very sore throat), THROAT TIGHTNESS (Almost felt it was closing up) and DYSPHAGIA (Hard time going down, almost felt like it was restricted) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included CPAP.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DRY THROAT (during the night very dry throat), OROPHARYNGEAL PAIN (very sore throat) and THROAT TIGHTNESS (Almost felt it was closing up). On 11-Mar-2021, the patient experienced DYSPHAGIA (Hard time going down, almost felt like it was restricted). The patient was treated with PARACETAMOL (TYLENOL) for Sore throat, at a dose of 2 dosage form. At the time of the report, DRY THROAT (during the night very dry throat), OROPHARYNGEAL PAIN (very sore throat), THROAT TIGHTNESS (Almost felt it was closing up) and DYSPHAGIA (Hard time going down, almost felt like it was restricted) outcome was unknown.            Concomitant medications details were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PAIN (Body ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PAIN (Body ache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PAIN (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Contact details updated
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Haemoptysis
Clinical narrative: Bleeding in the nose; He coughed, he saw blood; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Bleeding in the nose) and HAEMOPTYSIS (He coughed, he saw blood) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history reported by reporter.  Concomitant products included METOPROLOL for an unknown indication.    On 10-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 6:00 PM, the patient experienced EPISTAXIS (Bleeding in the nose) and HAEMOPTYSIS (He coughed, he saw blood). At the time of the report, EPISTAXIS (Bleeding in the nose) and HAEMOPTYSIS (He coughed, he saw blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was treated with cold water.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received reporter details updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: COVID-19 Vaccine) (batch nos. 013M20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (reaction has improved but it still has some discoloration), VACCINATION SITE WARMTH (felt hot/ had heat), VACCINATION SITE PRURITUS (Had very severe itching) and VACCINATION SITE RASH (A rash that was really red and got bigger each day,encompassed 2/3 of her arm and the width of it was as wide as the palm of the hand). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, VACCINATION SITE DISCOLOURATION (reaction has improved but it still has some discoloration) had not resolved and VACCINATION SITE WARMTH (felt hot/ had heat), VACCINATION SITE PRURITUS (Had very severe itching) and VACCINATION SITE RASH (A rash that was really red and got bigger each day,encompassed 2/3 of her arm and the width of it was as wide as the palm of the hand) was resolving.            Patient used unspecified medication for itching. No relevant concomitant medications were reported.   This case was linked to MOD-2021-041015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received captured no new information.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Chills, Dyspnoea, Erythema, Oxygen saturation
Clinical narrative: Acting a little loopy; Red all over; Trouble breathing; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (Acting a little loopy), ERYTHEMA (Red all over), DYSPNOEA (Trouble breathing) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021 at 5:00 PM, 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) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ABNORMAL BEHAVIOUR (Acting a little loopy), ERYTHEMA (Red all over), DYSPNOEA (Trouble breathing) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABNORMAL BEHAVIOUR (Acting a little loopy), ERYTHEMA (Red all over), DYSPNOEA (Trouble breathing) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Oxygen saturation: 97 percent (normal) normal.         Concomitant product use was not provided.  On an unspecified date the patient started to feel better.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, N-terminal prohormone brain natriuretic peptide, N-terminal prohormone brain natriuretic peptide increased, Pain
Clinical narrative: pain; muscle aches; rise with his proBNP which went up to 4000; This spontaneous case was reported by a nurse and describes the occurrence of N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED (rise with his proBNP which went up to 4000), PAIN (pain) and MYALGIA (muscle aches) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Congestive heart failure.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED (rise with his proBNP which went up to 4000). On an unknown date, the patient experienced PAIN (pain) and MYALGIA (muscle aches). On 10-Mar-2021, N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED (rise with his proBNP which went up to 4000) had resolved. At the time of the report, PAIN (pain) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, N-terminal prohormone brain natriuretic peptide: 4000 (High) rise. On 10-Mar-2021, N-terminal prohormone brain natriuretic peptide: 2000 (Inconclusive) 2000 (went back down to what it was before he took the vaccination which was 2000).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: got sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (got sore arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (got sore arm). At the time of the report, PAIN IN EXTREMITY (got sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Gait inability, Hypoaesthesia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: numbness on right side of his body; tingling on right side of body; burning sensation on right side of his body; neurological pain; could not able to walk; could not take shower and could not drive car; severe ache all over the body like head to toe; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness on right side of his body), PARAESTHESIA (tingling on right side of body), BURNING SENSATION (burning sensation on right side of his body), NEURALGIA (neurological pain) and GAIT INABILITY (could not able to walk) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis since September 2007 and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRETIC) for Allergy, FINGOLIMOD HYDROCHLORIDE (GILENYA) for Multiple sclerosis, METFORMIN, GLIPIZIDE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    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 HYPOAESTHESIA (numbness on right side of his body), PARAESTHESIA (tingling on right side of body), BURNING SENSATION (burning sensation on right side of his body), NEURALGIA (neurological pain), GAIT INABILITY (could not able to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take shower and could not drive car) and MYALGIA (severe ache all over the body like head to toe). The patient was treated with PREDNISONE at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (numbness on right side of his body), PARAESTHESIA (tingling on right side of body), BURNING SENSATION (burning sensation on right side of his body), NEURALGIA (neurological pain), GAIT INABILITY (could not able to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take shower and could not drive car) and MYALGIA (severe ache all over the body like head to toe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: numbness on right side of his body; tingling on right side of body; burning sensation on right side of his body; neurological pain; could not able to walk; could not take shower and could not drive car; severe ache all over the body like head to toe; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness on right side of his body), PARAESTHESIA (tingling on right side of body), BURNING SENSATION (burning sensation on right side of his body), NEURALGIA (neurological pain) and GAIT INABILITY (could not able to walk) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis since September 2007 and Allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRETIC) for Allergy, FINGOLIMOD HYDROCHLORIDE (GILENYA) for Multiple sclerosis, METFORMIN, GLIPIZIDE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    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 HYPOAESTHESIA (numbness on right side of his body), PARAESTHESIA (tingling on right side of body), BURNING SENSATION (burning sensation on right side of his body), NEURALGIA (neurological pain), GAIT INABILITY (could not able to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take shower and could not drive car) and MYALGIA (severe ache all over the body like head to toe). The patient was treated with PREDNISONE at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (numbness on right side of his body), PARAESTHESIA (tingling on right side of body), BURNING SENSATION (burning sensation on right side of his body), NEURALGIA (neurological pain), GAIT INABILITY (could not able to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not take shower and could not drive car) and MYALGIA (severe ache all over the body like head to toe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash macular
Clinical narrative: red spot; Pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spot) and PAIN (Pain) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH MACULAR (red spot) and PAIN (Pain). At the time of the report, RASH MACULAR (red spot) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. Treatment details was reported as ice pack.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Vaccination site erythema, Vomiting
Clinical narrative: Nausea; Vomiting; Chills; Red in her arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red in her arm at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red in her arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Mar-2021, NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red in her arm at the injection site) had not resolved. Not Provided          Concomitant medications included blood pressure pills and cholesterol pills.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Inflammation, Myalgia, Pyrexia
Clinical narrative: Experience some kind of inflammation; spike in temperature- 99'F; body aching; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Experience some kind of inflammation), PYREXIA (spike in temperature- 99'F) and MYALGIA (body aching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Pre-diabetes. Concomitant products included AMLODIPINE BESILATE (NORVASC) for Hypertension, METFORMIN for Pre-diabetes, SIMVASTATIN, ATENOLOL and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced INFLAMMATION (Experience some kind of inflammation), PYREXIA (spike in temperature- 99'F) and MYALGIA (body aching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLAMMATION (Experience some kind of inflammation), PYREXIA (spike in temperature- 99'F) and MYALGIA (body aching) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99 DF (High) spike in temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash was itching) and RASH (rash is on both arms and inside elbow and on back,rash on legs look like a mosquito bite on each leg) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced RASH PRURITIC (rash was itching) and RASH (rash is on both arms and inside elbow and on back,rash on legs look like a mosquito bite on each leg). At the time of the report, RASH PRURITIC (rash was itching) and RASH (rash is on both arms and inside elbow and on back,rash on legs look like a mosquito bite on each leg) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details included One dose of diphenhydramine last night.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Peripheral swelling, Urticaria, Vaccination site erythema
Clinical narrative: Arm swollen; Arm had welts and looked like hives; Arm pale; vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), URTICARIA (Arm had welts and looked like hives), PALLOR (Arm pale) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen), URTICARIA (Arm had welts and looked like hives), PALLOR (Arm pale) and VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, PERIPHERAL SWELLING (Arm swollen), URTICARIA (Arm had welts and looked like hives), PALLOR (Arm pale) and VACCINATION SITE ERYTHEMA (vaccination site erythema) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment medication details was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: Nausea; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Additional information received on 2 May 2021: updated the outcome of the events from unknown to recovering/ resolving. Denied to Follow up again.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's medical history information was not provided.  Concomitant products included SERTRALINE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 03-Apr-2021. On 14-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 14-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Bone pain, Chills, Dizziness
Clinical narrative: sicker than a horse; weakness; stomach upset; every bone in her body hurt, she would move a toe and everything would hurt.; dizziness; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sicker than a horse), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach upset), BONE PAIN (every bone in her body hurt, she would move a toe and everything would hurt.) and DIZZINESS (dizziness) in a 71-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 Pneumonia (Past history of pneumonia that left her hospitalized which is why she got vaccinated). Concomitant products included METFORMIN and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 25-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 ILLNESS (sicker than a horse), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach upset), BONE PAIN (every bone in her body hurt, she would move a toe and everything would hurt.), DIZZINESS (dizziness), NAUSEA (nausea) and CHILLS (chills). At the time of the report, ILLNESS (sicker than a horse), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach upset), BONE PAIN (every bone in her body hurt, she would move a toe and everything would hurt.), DIZZINESS (dizziness), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: sicker than a horse; weakness; stomach upset; every bone in her body hurt, she would move a toe and everything would hurt.; dizziness; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sicker than a horse), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach upset), BONE PAIN (every bone in her body hurt, she would move a toe and everything would hurt.) and DIZZINESS (dizziness) in a 71-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 Pneumonia (Past history of pneumonia that left her hospitalized which is why she got vaccinated). Concomitant products included METFORMIN and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 25-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 ILLNESS (sicker than a horse), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach upset), BONE PAIN (every bone in her body hurt, she would move a toe and everything would hurt.), DIZZINESS (dizziness), NAUSEA (nausea) and CHILLS (chills). At the time of the report, ILLNESS (sicker than a horse), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach upset), BONE PAIN (every bone in her body hurt, she would move a toe and everything would hurt.), DIZZINESS (dizziness), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: Runny nose; Slight cold; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and NASOPHARYNGITIS (Slight cold) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 12-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 RHINORRHOEA (Runny nose) and NASOPHARYNGITIS (Slight cold). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RHINORRHOEA (Runny nose) and NASOPHARYNGITIS (Slight cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  They consulted with their HCP who thought that they could attend but advised the patient to call Moderna.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Patient was due for the 2nd dose on 26 Feb 2021; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) and PRODUCT DOSE OMISSION ISSUE (Patient was due for the 2nd dose on 26 Feb 2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ), INSULIN GLARGINE (LANTUS), GABAPENTIN, METFORMIN, SIMVASTATIN and CARVEDILOL for an unknown indication.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced COVID-19 (Tested positive for COVID). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient was due for the 2nd dose on 26 Feb 2021). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient was due for the 2nd dose on 26 Feb 2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not reported by the reporter.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown  with no associated AEs. COVID-19 in this patient is unlikely to be due to the  Moderna (mRNA-1273) vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Fatigue, Magnetic resonance imaging, Memory impairment
Clinical narrative: Slow return of her memory; Fatigue for 7 days; Brain couldn't put into action what she needed to do.; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Brain couldn't put into action what she needed to do.), MEMORY IMPAIRMENT (Slow return of her memory) and FATIGUE (Fatigue for 7 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DISORIENTATION (Brain couldn't put into action what she needed to do.). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Slow return of her memory) and FATIGUE (Fatigue for 7 days). At the time of the report, DISORIENTATION (Brain couldn't put into action what she needed to do.), MEMORY IMPAIRMENT (Slow return of her memory) and FATIGUE (Fatigue for 7 days) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Magnetic resonance imaging: Inconclusive.         No concomitant medication and treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Non-significant Follow up received on 05-May-2021, The email id was added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: few bumps - small area on vaccine site - left arm; itches occasionally - small area on vaccine site - left arm; rash - small area on vaccine site - left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (few bumps - small area on vaccine site - left arm), VACCINATION SITE PRURITUS (itches occasionally - small area on vaccine site - left arm) and VACCINATION SITE RASH (rash - small area on vaccine site - left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A2A or 001A2H) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE MASS (few bumps - small area on vaccine site - left arm), VACCINATION SITE PRURITUS (itches occasionally - small area on vaccine site - left arm) and VACCINATION SITE RASH (rash - small area on vaccine site - left arm). At the time of the report, VACCINATION SITE MASS (few bumps - small area on vaccine site - left arm), VACCINATION SITE PRURITUS (itches occasionally - small area on vaccine site - left arm) and VACCINATION SITE RASH (rash - small area on vaccine site - left arm) 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 details was reported. No treatment medication details was reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood pressure measurement, Dizziness, Fatigue
Clinical narrative: Not back to his normal self; stomach started feeling upset maybe from talking about it; Legs got heavy; WEAK; Dizzy; tired; blood pressure shot up; pulse went up to 114 beats per minute; WEAKNESS; Feeling weak; Headache; Painful arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Legs got heavy), FEELING ABNORMAL (Not back to his normal self), ASTHENIA (Feeling weak), HEADACHE (Headache) and PAIN IN EXTREMITY (Painful arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ASTHENIA (Feeling weak), HEADACHE (Headache), PAIN IN EXTREMITY (Painful arm), BLOOD PRESSURE MEASUREMENT (blood pressure shot up), HEART RATE INCREASED (pulse went up to 114 beats per minute) and ASTHENIA (WEAKNESS). On 23-Feb-2021, the patient experienced DIZZINESS (Dizzy), FATIGUE (tired) and ASTHENIA (WEAK). On 01-Mar-2021, the patient experienced LIMB DISCOMFORT (Legs got heavy). On 11-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach started feeling upset maybe from talking about it). On an unknown date, the patient experienced FEELING ABNORMAL (Not back to his normal self). The patient was treated with IBUPROFEN (oral) at a dose of 1 dosage form. On 22-Jan-2021, ASTHENIA (Feeling weak), BLOOD PRESSURE MEASUREMENT (blood pressure shot up) and HEART RATE INCREASED (pulse went up to 114 beats per minute) had resolved. On 25-Jan-2021, HEADACHE (Headache), PAIN IN EXTREMITY (Painful arm) and ASTHENIA (WEAKNESS) had resolved. At the time of the report, LIMB DISCOMFORT (Legs got heavy), FEELING ABNORMAL (Not back to his normal self), DIZZINESS (Dizzy), FATIGUE (tired), ASTHENIA (WEAK) and ABDOMINAL DISCOMFORT (stomach started feeling upset maybe from talking about it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Heart rate: 114 (Inconclusive) beats per minute.         This case was linked to MOD-2021-223803 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: No NewInformation