chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Brutal after second dose; She is dizzy; Diarrhea; Her back hurts from the middle down towards her legs; Has palpitations at times she can feel her heart; She fell and was lying on the floor for a while until she managed to get up; Sweating; Vomiting; Headache; High fever; Shivering; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs) and PALPITATIONS (Has palpitations at times she can feel her heart) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044821A and 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs), PALPITATIONS (Has palpitations at times she can feel her heart), FALL (She fell and was lying on the floor for a while until she managed to get up), HYPERHIDROSIS (Sweating), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (High fever) and CHILLS (Shivering). At the time of the report, FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs), PALPITATIONS (Has palpitations at times she can feel her heart), FALL (She fell and was lying on the floor for a while until she managed to get up), HYPERHIDROSIS (Sweating), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (High fever) and CHILLS (Shivering) outcome was unknown.            No concomitant medications provided.  Treatment information mentioned Tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-132469 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient's second dose is outside of recommended interval between the first and second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient's second dose is outside of recommended interval between the first and second dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient's second dose is outside of recommended interval between the first and second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient's second dose is outside of recommended interval between the first and second 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 provided. Treatment medications was not provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: cold symptoms; pain in the area of the arm where the shots were applied.; received second Moderna vaccine dose at 17 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received second Moderna vaccine dose at 17 years old), NASOPHARYNGITIS (cold symptoms) and VACCINATION SITE PAIN (pain in the area of the arm where the shots were applied.) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 043B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included BACILLUS COAGULANS (PROBIOTIC GUMMIES) for an unknown indication.   On 14-Apr-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021 at 3:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received second Moderna vaccine dose at 17 years old). On an unknown date, the patient experienced NASOPHARYNGITIS (cold symptoms) and VACCINATION SITE PAIN (pain in the area of the arm where the shots were applied.). On 14-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received second Moderna vaccine dose at 17 years old) had resolved. At the time of the report, NASOPHARYNGITIS (cold symptoms) had resolved and VACCINATION SITE PAIN (pain in the area of the arm where the shots were applied.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant medication included multivitamin gummies Treatment information provided as cold medications.   This case was linked to MOD-2021-128135 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received, Updated patient demographics , vaccine information. Added concomitant medication , adverse event vaccination site pain. On 20-Jul-2021: Follow-up received on 20-JUL-2021 and contains significant information added treatment medications and added new event (cold symptoms).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial punctured 7May2021 and given 13May2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial punctured 7May2021 and given 13May2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 13-May-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 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vial punctured 7May2021 and given 13May2021). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (vial punctured 7May2021 and given 13May2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received reporters demographics was updated On 19-Jul-2021: Follow up was received Patient's demographics (weight) was added, administration site was  added of dose 2, batch number was added
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Clinomania, Headache, Injection site pain, Pyrexia
Clinical narrative: Cannot get out of bed; Headache; Fever; Pain on arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of CLINOMANIA (Cannot get out of bed), INJECTION SITE PAIN (Pain on arm of injection), HEADACHE (Headache) and PYREXIA (Fever) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced INJECTION SITE PAIN (Pain on arm of injection). On 16-May-2021, the patient experienced CLINOMANIA (Cannot get out of bed), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, CLINOMANIA (Cannot get out of bed), INJECTION SITE PAIN (Pain on arm of injection), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No  concomitant medical  provided by the reporter. No treatment information provided by the reporter.    This case was linked to MOD-2021-132202 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: More than 42 days after the first dose; Sore arm from the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days after the first dose) and PAIN IN EXTREMITY (Sore arm from the first dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm from the first dose). On 15-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days after the first dose). On 15-May-2021, PRODUCT DOSE OMISSION ISSUE (More than 42 days after the first dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm from the first dose) 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 medication details was reported. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Menopause
Clinical narrative: Menopause; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENOPAUSE (Menopause) 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 14-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced MENOPAUSE (Menopause). At the time of the report, MENOPAUSE (Menopause) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and Concomitant medicines were not included,  Action taken with mRNA-1273 in response to the event was unknown
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second  dose/has not received her second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second  dose/has not received her second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     No history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second  dose/has not received her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second  dose/has not received her second dose) had resolved.            No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-Jun-2021 and reporter information has been updated
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Asthenia, Defaecation urgency, Fall, Hyperhidrosis
Clinical narrative: so weak, even weaker; nose running profusely; almost dropped twice; threw up; a bad reaction; became really weak/since then was very weak; suddenly had to do number one and number two; head was sweating to death; nose running profusely; suddenly had to do number one and number two; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE REACTION (a bad reaction), ASTHENIA (became really weak/since then was very weak), MICTURITION URGENCY (suddenly had to do number one and number two), HYPERHIDROSIS (head was sweating to death) and the first episode of RHINORRHOEA (nose running profusely) in a 76-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.     Concomitant products included METFORMIN, LISINOPRIL and PAROXETINE for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced ADVERSE REACTION (a bad reaction), ASTHENIA (became really weak/since then was very weak), MICTURITION URGENCY (suddenly had to do number one and number two), HYPERHIDROSIS (head was sweating to death), the first episode of RHINORRHOEA (nose running profusely), DEFAECATION URGENCY (suddenly had to do number one and number two) and VOMITING (threw up). On 13-May-2021, the patient experienced ASTHENIA (so weak, even weaker), the second episode of RHINORRHOEA (nose running profusely) and FALL (almost dropped twice). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of three at a time and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of two at a time. At the time of the report, ADVERSE REACTION (a bad reaction), ASTHENIA (became really weak/since then was very weak), MICTURITION URGENCY (suddenly had to do number one and number two), HYPERHIDROSIS (head was sweating to death), DEFAECATION URGENCY (suddenly had to do number one and number two), ASTHENIA (so weak, even weaker), the last episode of RHINORRHOEA (nose running profusely), FALL (almost dropped twice) and VOMITING (threw up) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Consumer reports telling the person who gave the vaccine, of a family history of a mitochondrial condition. Also reported that she has made a decision not to take the second vaccine dose. Treatment included allergy pill two at one.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Micturition urgency, Rhinorrhoea, Vomiting
Clinical narrative: so weak, even weaker; nose running profusely; almost dropped twice; threw up; a bad reaction; became really weak/since then was very weak; suddenly had to do number one and number two; head was sweating to death; nose running profusely; suddenly had to do number one and number two; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE REACTION (a bad reaction), ASTHENIA (became really weak/since then was very weak), MICTURITION URGENCY (suddenly had to do number one and number two), HYPERHIDROSIS (head was sweating to death) and the first episode of RHINORRHOEA (nose running profusely) in a 76-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.     Concomitant products included METFORMIN, LISINOPRIL and PAROXETINE for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced ADVERSE REACTION (a bad reaction), ASTHENIA (became really weak/since then was very weak), MICTURITION URGENCY (suddenly had to do number one and number two), HYPERHIDROSIS (head was sweating to death), the first episode of RHINORRHOEA (nose running profusely), DEFAECATION URGENCY (suddenly had to do number one and number two) and VOMITING (threw up). On 13-May-2021, the patient experienced ASTHENIA (so weak, even weaker), the second episode of RHINORRHOEA (nose running profusely) and FALL (almost dropped twice). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of three at a time and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of two at a time. At the time of the report, ADVERSE REACTION (a bad reaction), ASTHENIA (became really weak/since then was very weak), MICTURITION URGENCY (suddenly had to do number one and number two), HYPERHIDROSIS (head was sweating to death), DEFAECATION URGENCY (suddenly had to do number one and number two), ASTHENIA (so weak, even weaker), the last episode of RHINORRHOEA (nose running profusely), FALL (almost dropped twice) and VOMITING (threw up) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Consumer reports telling the person who gave the vaccine, of a family history of a mitochondrial condition. Also reported that she has made a decision not to take the second vaccine dose. Treatment included allergy pill two at one.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: 1/2 of the dose was not administered to patient; needle was not properly attached to the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (1/2 of the dose was not administered to patient) and DEVICE CONNECTION ISSUE (needle was not properly attached to the syringe) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-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 14-May-2021, the patient experienced UNDERDOSE (1/2 of the dose was not administered to patient) and DEVICE CONNECTION ISSUE (needle was not properly attached to the syringe). On 14-May-2021, UNDERDOSE (1/2 of the dose was not administered to patient) and DEVICE CONNECTION ISSUE (needle was not properly attached to the syringe) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Myalgia, Product dose omission issue, Rash, Vaccination complication
Clinical narrative: Bad reaction to the 1st dose; Left eye killing her after the 1st dose,Left eye hurts everyday after the 1st dose; Didn't get the 2nd dose; Huge rash all over her body after 1st dose; Arm sore after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction to the 1st dose), EYE PAIN (Left eye killing her after the 1st dose,Left eye hurts everyday after the 1st dose), PRODUCT DOSE OMISSION ISSUE (Didn't get the 2nd dose), RASH (Huge rash all over her body after 1st dose) and MYALGIA (Arm sore after the 1st dose) 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 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 VACCINATION COMPLICATION (Bad reaction to the 1st dose), EYE PAIN (Left eye killing her after the 1st dose,Left eye hurts everyday after the 1st dose), PRODUCT DOSE OMISSION ISSUE (Didn't get the 2nd dose), RASH (Huge rash all over her body after 1st dose) and MYALGIA (Arm sore after the 1st dose). At the time of the report, VACCINATION COMPLICATION (Bad reaction to the 1st dose), EYE PAIN (Left eye killing her after the 1st dose,Left eye hurts everyday after the 1st dose), PRODUCT DOSE OMISSION ISSUE (Didn't get the 2nd dose), RASH (Huge rash all over her body after 1st dose) and MYALGIA (Arm sore after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 001M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with CORTISONE at an unspecified dose and frequency. On 15-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            No concomitant medications were reported.   Treatment included Ibuprofen, pain pill, icy hot, hot baths, ice, heating pads
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Deviation from interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from interval) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Deviation from interval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: feverish; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish) and CHILLS (chills) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced PYREXIA (feverish) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (EQUATE DAILY) for Cold, Flu and Sore throat, at an unspecified dose and frequency. At the time of the report, PYREXIA (feverish) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Muscle soreness; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Muscle soreness) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 14-May-2021, the patient experienced MYALGIA (Muscle soreness). On 03-Apr-2021, VACCINATION SITE PAIN (Soreness at the injection site) had resolved. At the time of the report, MYALGIA (Muscle soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include High blood pressure medications. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-133302 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up received on 14-JUN-2021. Event outcome has been  updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-133302:mother
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site bruising, Vaccination site granuloma, Vaccination site mass, Vaccination site pain
Clinical narrative: Had hard lump on vaccination site; It was in verge of granuloma; Now there is a bruise; Hollowunderneath the skin of injection site, It was in verge of boil; It was very painful; They gave me a shot in my subcutaneous fat; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (Had hard lump on vaccination site), VACCINATION SITE GRANULOMA (It was in verge of granuloma), VACCINATION SITE BRUISING (Now there is a bruise), VACCINATION SITE REACTION (Hollowunderneath the skin of injection site, It was in verge of boil) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave me a shot in my subcutaneous fat) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 27-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave me a shot in my subcutaneous fat). On 28-Apr-2021, the patient experienced VACCINATION SITE MASS (Had hard lump on vaccination site), VACCINATION SITE GRANULOMA (It was in verge of granuloma), VACCINATION SITE BRUISING (Now there is a bruise), VACCINATION SITE REACTION (Hollowunderneath the skin of injection site, It was in verge of boil) and VACCINATION SITE PAIN (It was very painful). On 27-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave me a shot in my subcutaneous fat) had resolved. At the time of the report, VACCINATION SITE MASS (Had hard lump on vaccination site), VACCINATION SITE GRANULOMA (It was in verge of granuloma), VACCINATION SITE BRUISING (Now there is a bruise), VACCINATION SITE REACTION (Hollowunderneath the skin of injection site, It was in verge of boil) and VACCINATION SITE PAIN (It was very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Had hard lump on vaccination site; It was in verge of granuloma; Now there is a bruise; Hollowunderneath the skin of injection site, It was in verge of boil; It was very painful; They gave me a shot in my subcutaneous fat; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (Had hard lump on vaccination site), VACCINATION SITE GRANULOMA (It was in verge of granuloma), VACCINATION SITE BRUISING (Now there is a bruise), VACCINATION SITE REACTION (Hollowunderneath the skin of injection site, It was in verge of boil) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave me a shot in my subcutaneous fat) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 27-Apr-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave me a shot in my subcutaneous fat). On 28-Apr-2021, the patient experienced VACCINATION SITE MASS (Had hard lump on vaccination site), VACCINATION SITE GRANULOMA (It was in verge of granuloma), VACCINATION SITE BRUISING (Now there is a bruise), VACCINATION SITE REACTION (Hollowunderneath the skin of injection site, It was in verge of boil) and VACCINATION SITE PAIN (It was very painful). On 27-Apr-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (They gave me a shot in my subcutaneous fat) had resolved. At the time of the report, VACCINATION SITE MASS (Had hard lump on vaccination site), VACCINATION SITE GRANULOMA (It was in verge of granuloma), VACCINATION SITE BRUISING (Now there is a bruise), VACCINATION SITE REACTION (Hollowunderneath the skin of injection site, It was in verge of boil) and VACCINATION SITE PAIN (It was very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: has not yet received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not yet received the second dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not yet received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not yet received the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has not yet received the second dose because she could not attend her appointment on 04 May 2021.  No relevant concomitant medications were reported
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: 44 days after receiving the first dose; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days after receiving the first dose) and VACCINATION SITE PAIN (Soreness at the injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and High blood pressure medications for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days after receiving the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (44 days after receiving the first dose) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported. Action taken with mRNA-1273 in response to the events was not Applicable
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: arm hot and red; Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day; low grade fever of 99; sore arm; an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling; arm hot and red; accelerated pounding heart beat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling), VACCINATION SITE WARMTH (arm hot and red), HEART RATE INCREASED (accelerated pounding heart beat), ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day) and PYREXIA (low grade fever of 99) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A-2A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced FEELING ABNORMAL (an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling), VACCINATION SITE WARMTH (arm hot and red), HEART RATE INCREASED (accelerated pounding heart beat), PYREXIA (low grade fever of 99) and MYALGIA (sore arm). On 11-Feb-2021, the patient experienced ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm hot and red). On 15-Apr-2021, PYREXIA (low grade fever of 99) outcome was unknown. At the time of the report, FEELING ABNORMAL (an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling), VACCINATION SITE WARMTH (arm hot and red), HEART RATE INCREASED (accelerated pounding heart beat), ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day), MYALGIA (sore arm) and VACCINATION SITE ERYTHEMA (arm hot and red) outcome 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 was provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-133172 (E2B Linked Report). This case was linked to MOD-2021-133049, MOD-2021-133270 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-133172:Case for patient first dose
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: arm hot and red; Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day; low grade fever of 99; sore arm; an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling; arm hot and red; accelerated pounding heart beat; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling), VACCINATION SITE WARMTH (arm hot and red), HEART RATE INCREASED (accelerated pounding heart beat), ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day) and PYREXIA (low grade fever of 99) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A-2A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced FEELING ABNORMAL (an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling), VACCINATION SITE WARMTH (arm hot and red), HEART RATE INCREASED (accelerated pounding heart beat), PYREXIA (low grade fever of 99) and MYALGIA (sore arm). On 11-Feb-2021, the patient experienced ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm hot and red). On 15-Apr-2021, PYREXIA (low grade fever of 99) outcome was unknown. At the time of the report, FEELING ABNORMAL (an unpleasant weird feeling within half hour of vaccination/brain fog/jittery tremor feeling), VACCINATION SITE WARMTH (arm hot and red), HEART RATE INCREASED (accelerated pounding heart beat), ANXIETY (Both the anxiety and brain fog lasted for 2 weeks after each dose and disappeared one day), MYALGIA (sore arm) and VACCINATION SITE ERYTHEMA (arm hot and red) outcome 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 was provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-133172 (E2B Linked Report). This case was linked to MOD-2021-133049, MOD-2021-133270 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-133172:Case for patient first dose
Sex: M
Vaccine: COVID19
Symptoms: Acne, Herpes zoster, Pustule
Clinical narrative: vaccination stirred up herpes zoster; I have a breakout; pustules on sacral area; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (vaccination stirred up herpes zoster), ACNE (I have a breakout) and PUSTULE (pustules on sacral area) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. declined) 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 HERPES ZOSTER (vaccination stirred up herpes zoster), ACNE (I have a breakout) and PUSTULE (pustules on sacral area). At the time of the report, HERPES ZOSTER (vaccination stirred up herpes zoster), ACNE (I have a breakout) and PUSTULE (pustules on sacral area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Muscle spasms, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasm or cramp in right leg), DIARRHEA (diarrhea), TENDERNESS (Feels a similar tenderness or soreness as she did after getting the shot), CHILLS (Experienced chills) and NAUSEA (Nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced CHILLS (Experienced chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and FATIGUE (Felt a little tired). On 13-May-2021, the patient experienced MUSCLE SPASMS (muscle spasm or cramp in right leg) and DIARRHEA (diarrhea). On 15-May-2021, the patient experienced TENDERNESS (Feels a similar tenderness or soreness as she did after getting the shot). At the time of the report, MUSCLE SPASMS (muscle spasm or cramp in right leg), DIARRHEA (diarrhea), TENDERNESS (Feels a similar tenderness or soreness as she did after getting the shot), CHILLS (Experienced chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and FATIGUE (Felt a little tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator. Her sister helped her massage her leg cramp is the treatment medication reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tenderness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasm or cramp in right leg), DIARRHEA (diarrhea), TENDERNESS (Feels a similar tenderness or soreness as she did after getting the shot), CHILLS (Experienced chills) and NAUSEA (Nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced CHILLS (Experienced chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and FATIGUE (Felt a little tired). On 13-May-2021, the patient experienced MUSCLE SPASMS (muscle spasm or cramp in right leg) and DIARRHEA (diarrhea). On 15-May-2021, the patient experienced TENDERNESS (Feels a similar tenderness or soreness as she did after getting the shot). At the time of the report, MUSCLE SPASMS (muscle spasm or cramp in right leg), DIARRHEA (diarrhea), TENDERNESS (Feels a similar tenderness or soreness as she did after getting the shot), CHILLS (Experienced chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and FATIGUE (Felt a little tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator. Her sister helped her massage her leg cramp is the treatment medication reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Received first dose of vaccine 30 hours after it was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received first dose of vaccine 30 hours after it was punctured) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received first dose of vaccine 30 hours after it was punctured). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received first dose of vaccine 30 hours after it was punctured) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-132146 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132146:Crosslink
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Feeling abnormal, Injection site induration, Mobility decreased
Clinical narrative: feeling bad; piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve; and she can feel a knot inside and is wondering if they hit a nerve; pain spreading across chest into right arm/chest pain; muscle spasms; not able to lift right arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (pain spreading across chest into right arm/chest pain), MUSCLE SPASMS (muscle spasms), MOBILITY DECREASED (not able to lift right arm), FEELING ABNORMAL (feeling bad) and VACCINATION SITE PAIN (piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced CHEST PAIN (pain spreading across chest into right arm/chest pain), MUSCLE SPASMS (muscle spasms), MOBILITY DECREASED (not able to lift right arm), VACCINATION SITE PAIN (piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve) and INJECTION SITE INDURATION (and she can feel a knot inside and is wondering if they hit a nerve). On an unknown date, the patient experienced FEELING ABNORMAL (feeling bad). The patient was treated with CORTISONE for Pain, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, CHEST PAIN (pain spreading across chest into right arm/chest pain) and MUSCLE SPASMS (muscle spasms) was resolving and MOBILITY DECREASED (not able to lift right arm), FEELING ABNORMAL (feeling bad), VACCINATION SITE PAIN (piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve) and INJECTION SITE INDURATION (and she can feel a knot inside and is wondering if they hit a nerve) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Electrocardiogram: unknown (Inconclusive) unknown..         Concomitant medications were not reported. Treatment was reported as:  pain pill, icy hot, hot baths, ice, heating pads   This case was linked to MOD-2021-132741 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant follow up  received on 26-may-2021 event outcome updated.