chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Cardiovascular disorder, Constipation, Cough
Clinical narrative: headache comes instant of cough; feels in back of neck; not getting good blood flow to capillaries; feels in back of neck; constipated; pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it; COVID-19; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck) and CONSTIPATION (constipated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Venous stasis (in Leg). Concomitant products included AMLODIPINE, BENAZEPRIL and HYDROCHLOROTHIAZIDE for Blood pressure, PRAVASTATIN for Cholesterol.    On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck), CONSTIPATION (constipated), HEADACHE (pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck), CONSTIPATION (constipated), HEADACHE (pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication was mentioned
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Headache, Neck pain
Clinical narrative: headache comes instant of cough; feels in back of neck; not getting good blood flow to capillaries; feels in back of neck; constipated; pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it; COVID-19; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck) and CONSTIPATION (constipated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Venous stasis (in Leg). Concomitant products included AMLODIPINE, BENAZEPRIL and HYDROCHLOROTHIAZIDE for Blood pressure, PRAVASTATIN for Cholesterol.    On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck), CONSTIPATION (constipated), HEADACHE (pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COUGH (headache comes instant of cough), BACK PAIN (feels in back of neck), CARDIOVASCULAR DISORDER (not getting good blood flow to capillaries), NECK PAIN (feels in back of neck), CONSTIPATION (constipated), HEADACHE (pulse headache/like pulse, or pressure headache/feels like hammer cracking head with it), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medication was mentioned
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: strong reaction to the first shot/pretty rough night; very intense body aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strong reaction to the first shot/pretty rough night), MYALGIA (very intense body aches), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Fibromyalgia, Arthritis, Hives (breaks in hives in response to foods.) and Food allergy.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (strong reaction to the first shot/pretty rough night), MYALGIA (very intense body aches), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination adverse reaction, Myalgia, Pyrexia and Chills, at an unspecified dose and frequency. In 2021, VACCINATION COMPLICATION (strong reaction to the first shot/pretty rough night), MYALGIA (very intense body aches), PYREXIA (Fever) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication inhaler was provided.   This case was linked to MOD-2021-307238, MOD-2021-307256 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac discomfort, Chest X-ray, Electrocardiogram, Heart rate
Clinical narrative: My heart was heavy; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (My heart was heavy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC DISCOMFORT (My heart was heavy). At the time of the report, CARDIAC DISCOMFORT (My heart was heavy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Blood test: normal (normal) normal. On 14-Aug-2021, Chest X-ray: normal (normal) normal. On 14-Aug-2021, Electrocardiogram: normal (normal) normal. On 14-Aug-2021, Heart rate: 100 to 78 (abnormal) 100 to 78. On 30-Aug-2021, Blood test: normal (normal) normal. On 30-Aug-2021, Chest X-ray: normal (normal) normal. On 30-Aug-2021, Electrocardiogram: normal (normal) normal.         Concomitant medications were not provided. Treatment medications were not provided. Patient states that on 12-AUG-2021 she started feeling like her heart was heavy. Her watch read her heart rate and the heart rate increased. Even after getting results as normal for labs, these symptoms continue and she has made an appointment with a cardiologist whom she has not yet seen.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.    This case was linked to MOD-2021-307201 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Eye swelling, Inappropriate schedule of product administration, Rash
Clinical narrative: Second dose schedule more than 36 days from first dose; Allergy flare up; Eyes swelling; Rash on face; Rash on neck; Rash on arm and waistline; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swelling), ALLERGY TO VACCINE (Allergy flare up), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedule more than 36 days from first dose), RASH (Rash on arm and waistline) and RASH (Rash on face) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to drug excipient, Latex allergy and Allergy to synthetic fabric. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced RASH (Rash on arm and waistline). On 03-May-2021, the patient experienced EYE SWELLING (Eyes swelling), RASH (Rash on face) and RASH (Rash on neck). On 10-May-2021, the patient experienced ALLERGY TO VACCINE (Allergy flare up). On 04-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedule more than 36 days from first dose). The patient was treated with PREDNISONE (oral) for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Eyes swelling), ALLERGY TO VACCINE (Allergy flare up), RASH (Rash on arm and waistline), RASH (Rash on face) and RASH (Rash on neck) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose schedule more than 36 days from first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Two weeks after vaccination, the patient got a big rash on her arm and waistline. It got worse so she went to an urgent care and was given with corticosteroids and a cream. The symptoms went away but then after a week, it got more severe. The rashes went up to her face and neck and her eyes were swollen and she was then given again with higher dose of steroids. But few days after, for the third time, patient had flare up. She was prescribed with oral prednisone, a different cream and EpiPen incase of possible anaphylactic reaction. The patient was fine afterwards and consulted an allergologist. It was found out that she was allergic to polysorbent 80, latex and fabric polyester.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 102 temp day after the booster shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 temp day after the booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (102 temp day after the booster shot). At the time of the report, PYREXIA (102 temp day after the booster shot) outcome was unknown.            No concomitant medication provided.  No treatment medication provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (aches). At the time of the report, FATIGUE (fatigue), PYREXIA (fever) and MYALGIA (aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: little more soreness than the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (little more soreness than the 1st dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.    In February 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 MYALGIA (little more soreness than the 1st dose). At the time of the report, MYALGIA (little more soreness than the 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication include A-fib medication and Cholesterol medication.  Treatment information was not provided.   This case was linked to MOD-2021-308606, MOD-2021-308612 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: itching was gone again after Moderna booster shot; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (itching was gone again after Moderna booster shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Itching (all over my body that I had for years).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (itching was gone again after Moderna booster shot). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (itching was gone again after Moderna booster shot) had resolved.            No concomitant medications were provided by the reporter.  Treatment information was not provided. My itching all over my body that I had for years disappeared after my first Moderna shot February 1, 2021 the next day. About two weeks ago some of the itching recurred, so I got a Moderna booster shot and my itching was gone again.   This case was linked to MOD-2021-278963 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: A little sore arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (A little sore arm after second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Psoriasis. Concomitant products included RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for an unknown indication.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (A little sore arm after second dose). On 09-Apr-2021, MYALGIA (A little sore arm after second dose) had resolved.            Patient took Skyrizi injection in Feb 2021 (600mg) and May 2021 (300mg) and she was scheduled to have another Skyrizi injection in Sep 2021. Treatment Information was not provided. The patient had a little sore arm which lasted for 2 days.   This case was linked to MOD-2021-307186, MOD-2021-307237 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia
Clinical narrative: A little sore arm after third dose; Second dose on 07-APR-2021 and the third dose on 19-AUG-2021; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (A little sore arm after third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 07-APR-2021 and the third dose on 19-AUG-2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Autoimmune disorder. Concomitant products included RISANKIZUMAB RZAA (SKYRIZI [RISANKIZUMAB RZAA]) for an unknown indication.    On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced MYALGIA (A little sore arm after third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 07-APR-2021 and the third dose on 19-AUG-2021). On 19-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 07-APR-2021 and the third dose on 19-AUG-2021) had resolved. On 21-Aug-2021, MYALGIA (A little sore arm after third dose) had resolved.            Patient took Skyrizi injection in Feb 2021 (600mg) and May 2021 (300mg) and she was scheduled to have another Skyrizi injection in Sep 2021.  Treatment Information was not provided.   This case was linked to MOD-2021-307186, MOD-2021-307235 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination complication
Clinical narrative: felt a little punky; fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt a little punky), FATIGUE (fatigue) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Fibromyalgia, Arthritis and Food allergy (breaks in hives in response to foods).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, 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 experienced VACCINATION COMPLICATION (felt a little punky), FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, VACCINATION COMPLICATION (felt a little punky), FATIGUE (fatigue) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included inhaler.  No treatment medications were reported for second dose.   This case was linked to MOD-2021-307220, MOD-2021-307256 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Heart rate, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021); achy; feels like heart is beating too fast; slightly elevated temperature; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)), MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 014F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for Diabetes, APIXABAN (ELIQUIS) for an unknown indication.   On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)) had resolved and MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Body temperature: 100f (High) temperature is about 100F. On 04-Sep-2021, Heart rate: 97 beats per minute (High) Patient feels like his heart is beating a little bit too fast with 97 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient taken concomitant drug Blood pressure pill Treatment information was not provided
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021); achy; feels like heart is beating too fast; slightly elevated temperature; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)), MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 014F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for Diabetes, APIXABAN (ELIQUIS) for an unknown indication.   On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered(15-AUG-2021 Dose 1/2nd dose of Moderna vaccine 03Sept2021)) had resolved and MYALGIA (achy), HEART RATE INCREASED (feels like heart is beating too fast) and BODY TEMPERATURE INCREASED (slightly elevated temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Body temperature: 100f (High) temperature is about 100F. On 04-Sep-2021, Heart rate: 97 beats per minute (High) Patient feels like his heart is beating a little bit too fast with 97 beats per minute.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient taken concomitant drug Blood pressure pill Treatment information was not provided
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: first two shots were Pfizer and third dose as Moderna; first two shots were Pfizer and third dose as Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first two shots were Pfizer and third dose as Moderna) and INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer and third dose as Moderna) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first two shots were Pfizer and third dose as Moderna) and INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer and third dose as Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first two shots were Pfizer and third dose as Moderna) had resolved and INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer and third dose as Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took his first dose of Pfizer COVID-19 Vaccine on 07-JAN-2021 and second dose on 06-FEB-2021. No concomitant medications were reported. No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Product dose omission issue, Vaccination site rash
Clinical narrative: She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna; Rash on arm (injection site); Difficulty breathing; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), VACCINATION SITE RASH (Rash on arm (injection site)), DIZZINESS (Light headedness) and PRODUCT DOSE OMISSION ISSUE (She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tylenol) and Drug allergy (Codeine). Concomitant products included VITAMINS NOS, APPLE CIDER VINEGAR and OMEPRAZOLE (PRILOSEC [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 28-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), VACCINATION SITE RASH (Rash on arm (injection site)) and DIZZINESS (Light headedness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna). The patient was treated with EPINEPHRINE (intravenous) on 28-Feb-2021 for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 28-Feb-2021 for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, DYSPNOEA (Difficulty breathing), VACCINATION SITE RASH (Rash on arm (injection site)) and DIZZINESS (Light headedness) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (She said she got her first shot last 28Feb2021,She wants to get the second dose of Moderna) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient confirmed that she felt fine after taking treatment drugs. As per her doctor, she's not allergic to anything.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06EZ1A) for COVID-19 vaccination.     No medical history was reported by patient.  Concurrent medical conditions included COPD, Constipation, Heart disorder, Anxiety, GERD and Spasticity. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for COPD, ISOSORBIDE for Cardiac disorder, LUBIPROSTONE (AMITIZA) for Constipation, PANTOPRAZOL [PANTOPRAZOLE] for GERD, ACETYLSALICYLIC ACID (ASPIRINE) for Heart disorder, BACLOFEN for Spasticity, PARACETAMOL (TYLENOL) for an unknown indication.    On 21-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            Patient took diazepine as a concomitant medication for anxiety  No treatment medication was reported by patient.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Arthralgia, Chills, Cough, Insomnia
Clinical narrative: coughing; swelling under his left arm; kept him up; yelling at my wife is a side effect too; eight hours later patient had fever; chills; lymph nodes are swelled up; Frequent pain in knee; still has a fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too) and PYREXIA (still has a fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PYREXIA (still has a fever). On an unknown date, the patient experienced COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too), PYREXIA (eight hours later patient had fever), CHILLS (chills), LYMPHADENOPATHY (lymph nodes are swelled up) and ARTHRALGIA (Frequent pain in knee). The patient was treated with PARACETAMOL (TYLENOL) on 02-Sep-2021 for Adverse event, at a dose of 1 dosage form and IVERMECTIN for Adverse event, at a dose of 1 dosage form. At the time of the report, COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too), PYREXIA (eight hours later patient had fever), CHILLS (chills), LYMPHADENOPATHY (lymph nodes are swelled up) and ARTHRALGIA (Frequent pain in knee) outcome was unknown and PYREXIA (still has a fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medicine: Patient took advil on 03-sep-2021 for fever  No concomitant medicine were reported by the reporter
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: coughing; swelling under his left arm; kept him up; yelling at my wife is a side effect too; eight hours later patient had fever; chills; lymph nodes are swelled up; Frequent pain in knee; still has a fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too) and PYREXIA (still has a fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PYREXIA (still has a fever). On an unknown date, the patient experienced COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too), PYREXIA (eight hours later patient had fever), CHILLS (chills), LYMPHADENOPATHY (lymph nodes are swelled up) and ARTHRALGIA (Frequent pain in knee). The patient was treated with PARACETAMOL (TYLENOL) on 02-Sep-2021 for Adverse event, at a dose of 1 dosage form and IVERMECTIN for Adverse event, at a dose of 1 dosage form. At the time of the report, COUGH (coughing), PERIPHERAL SWELLING (swelling under his left arm), INSOMNIA (kept him up), ABNORMAL BEHAVIOUR (yelling at my wife is a side effect too), PYREXIA (eight hours later patient had fever), CHILLS (chills), LYMPHADENOPATHY (lymph nodes are swelled up) and ARTHRALGIA (Frequent pain in knee) outcome was unknown and PYREXIA (still has a fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medicine: Patient took advil on 03-sep-2021 for fever  No concomitant medicine were reported by the reporter
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Malaise, Somnolence, Tachycardia
Clinical narrative: very sleepy; I feel nervous; I feel like something is not ok; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy), ANXIETY (I feel nervous), MALAISE (I feel like something is not ok) and TACHYCARDIA (tachycardia) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced SOMNOLENCE (very sleepy), ANXIETY (I feel nervous), MALAISE (I feel like something is not ok) and TACHYCARDIA (tachycardia). At the time of the report, SOMNOLENCE (very sleepy), ANXIETY (I feel nervous) and MALAISE (I feel like something is not ok) outcome was unknown and TACHYCARDIA (tachycardia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Blood pressure measurement: 128/75 (High) 128/75.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Patient did not have history of myocarditis/pericarditis. However, patient mentioned that his heart was big. Patient's blood pressure was also high 128/75 (Patient usually had it around 65/70).
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic shock, COVID-19
Clinical narrative: Anaphylatic shock; Got Covid-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylatic shock) in a patient of an unknown age and gender 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 Animal protein allergy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC SHOCK (Anaphylatic shock) (seriousness criterion medically significant) and COVID-19 (Got Covid-19). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylatic shock) and COVID-19 (Got Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  A few people who had anaphylatic shock after getting the Covid-19 Vaccine got Covid.  Company Comment : Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. Regarding the event anaphylactic shock very limited information provided, however a causal relationship can not be excluded.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. Regarding the event anaphylactic shock very limited information provided, however a causal relationship can not be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: I have a large red area that is hard and its also hot, kinda itchy; I have a large red area that is hard and its also hot, kinda itchy; I have a large red area that is hard and its also hot, kinda itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (I have a large red area that is hard and its also hot, kinda itchy), FEELING HOT (I have a large red area that is hard and its also hot, kinda itchy) and PRURITUS (I have a large red area that is hard and its also hot, kinda itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (I have a large red area that is hard and its also hot, kinda itchy), FEELING HOT (I have a large red area that is hard and its also hot, kinda itchy) and PRURITUS (I have a large red area that is hard and its also hot, kinda itchy). At the time of the report, ERYTHEMA (I have a large red area that is hard and its also hot, kinda itchy), FEELING HOT (I have a large red area that is hard and its also hot, kinda itchy) and PRURITUS (I have a large red area that is hard and its also hot, kinda itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant and Treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Paraesthesia, Rash, Swelling
Clinical narrative: A friend of mine got her first dose today and seems to have an allergic reaction; rash; swelling; tingling in her neck and face; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (A friend of mine got her first dose today and seems to have an allergic reaction), RASH (rash), SWELLING (swelling) and PARAESTHESIA (tingling in her neck and face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (A friend of mine got her first dose today and seems to have an allergic reaction), RASH (rash), SWELLING (swelling) and PARAESTHESIA (tingling in her neck and face). At the time of the report, ALLERGY TO VACCINE (A friend of mine got her first dose today and seems to have an allergic reaction), RASH (rash), SWELLING (swelling) and PARAESTHESIA (tingling in her neck and face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Is leg tingling a side effect?; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Is leg tingling a side effect?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Is leg tingling a side effect?). At the time of the report, PARAESTHESIA (Is leg tingling a side effect?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 97.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: first two shots were Pfizer/third dose as Moderna; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer/third dose as Moderna) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 07-Jan-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer/third dose as Moderna). On 06-Feb-2021, INTERCHANGE OF VACCINE PRODUCTS (first two shots were Pfizer/third dose as Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Myalgia, Pruritus
Clinical narrative: The arm felt a little bit warm; Had some redness on the arm; Some itching; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (The arm felt a little bit warm), ERYTHEMA (Had some redness on the arm), PRURITUS (Some itching) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-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 FEELING HOT (The arm felt a little bit warm), ERYTHEMA (Had some redness on the arm), PRURITUS (Some itching) and MYALGIA (Body aches). At the time of the report, FEELING HOT (The arm felt a little bit warm), ERYTHEMA (Had some redness on the arm), PRURITUS (Some itching) and MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that the AE maybe lasted for 2-3 days  No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-307243 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vial punctured more than 12 hours before; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-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 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebrovascular accident, Feeling abnormal, Gait disturbance, Limb discomfort
Clinical narrative: Left arm went limp/ walks with a limp; Has a hard time putting words together; Left leg was heavy; Mind was foggy; Suffered a stroke on his left side; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Suffered a stroke on his left side), GAIT DISTURBANCE (Left arm went limp/ walks with a limp), APHASIA (Has a hard time putting words together), LIMB DISCOMFORT (Left leg was heavy) and FEELING ABNORMAL (Mind was foggy) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Suffered a stroke on his left side) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced GAIT DISTURBANCE (Left arm went limp/ walks with a limp) (seriousness criterion hospitalization), APHASIA (Has a hard time putting words together) (seriousness criterion hospitalization), LIMB DISCOMFORT (Left leg was heavy) (seriousness criterion hospitalization) and FEELING ABNORMAL (Mind was foggy) (seriousness criterion hospitalization). The patient was hospitalized from 17-Aug-2021 to 20-Aug-2021 due to APHASIA, CEREBROVASCULAR ACCIDENT, FEELING ABNORMAL, GAIT DISTURBANCE and LIMB DISCOMFORT. The patient was treated with TPA for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Suffered a stroke on his left side), GAIT DISTURBANCE (Left arm went limp/ walks with a limp), APHASIA (Has a hard time putting words together), LIMB DISCOMFORT (Left leg was heavy) and FEELING ABNORMAL (Mind was foggy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 17-Aug-2021, the patient went to emergency room, was transported to the hospital and was admitted through 20-Aug-2021. The received TPA treatment immediately.  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded. Further information has been requested.