chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine (Allergic to FLU Shot, can not take any shot that contain live or killed virus).    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 VACCINATION SITE PAIN (Soreness on the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provider by the reporter.  Treatment information was not provided.   Patient had first shot of Moderna COVID-19 vaccine three weeks ago .
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: warm to the touch; red bump rash; red bump rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE RASH (red bump rash) and VACCINATION SITE ERYTHEMA (red bump rash) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE RASH (red bump rash) and VACCINATION SITE ERYTHEMA (red bump rash). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE RASH (red bump rash) and VACCINATION SITE ERYTHEMA (red bump rash) outcome was unknown.            Concomitant medication information not provided. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain is almost into his shoulder; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and ARTHRALGIA (pain is almost into his shoulder) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ATENOLOL for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 10-Apr-2021, the patient experienced ARTHRALGIA (pain is almost into his shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 UNK and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form. On 06-Apr-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, ARTHRALGIA (pain is almost into his shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Atenolol  is used as concomitant medication.  Tylenol and Advil were reported as treatment.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Erythema, Mass, Pain in extremity, Pruritus
Clinical narrative: itchiness all over her body; rash all over arm; swelling; tiny bumps,bumps look like bug bites; redness; COVID arm; little pimples on my body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (swelling), MASS (tiny bumps,bumps look like bug bites), ERYTHEMA (redness), PAIN IN EXTREMITY (COVID arm) and ACNE (little pimples on my body) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced SWELLING (swelling), MASS (tiny bumps,bumps look like bug bites), ERYTHEMA (redness), PAIN IN EXTREMITY (COVID arm), ACNE (little pimples on my body) and RASH (rash all over arm). On 14-Apr-2021, the patient experienced PRURITUS (itchiness all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SWELLING (swelling), MASS (tiny bumps,bumps look like bug bites), ERYTHEMA (redness), PAIN IN EXTREMITY (COVID arm) and RASH (rash all over arm) had not resolved and ACNE (little pimples on my body) and PRURITUS (itchiness all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Updated patient details, product details. Added treatment medication. updated event details and event outcome. Added events pain in arm, pimples, rash.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: itchiness all over her body; rash all over arm; swelling; tiny bumps,bumps look like bug bites; redness; COVID arm; little pimples on my body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (swelling), MASS (tiny bumps,bumps look like bug bites), ERYTHEMA (redness), PAIN IN EXTREMITY (COVID arm) and ACNE (little pimples on my body) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced SWELLING (swelling), MASS (tiny bumps,bumps look like bug bites), ERYTHEMA (redness), PAIN IN EXTREMITY (COVID arm), ACNE (little pimples on my body) and RASH (rash all over arm). On 14-Apr-2021, the patient experienced PRURITUS (itchiness all over her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SWELLING (swelling), MASS (tiny bumps,bumps look like bug bites), ERYTHEMA (redness), PAIN IN EXTREMITY (COVID arm) and RASH (rash all over arm) had not resolved and ACNE (little pimples on my body) and PRURITUS (itchiness all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Updated patient details, product details. Added treatment medication. updated event details and event outcome. Added events pain in arm, pimples, rash.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pyrexia
Clinical narrative: weakness; fever of 102.4 degrees Fahrenheit; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 102.4 degrees Fahrenheit) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) 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 18-Apr-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). On 20-Apr-2021, the patient experienced ASTHENIA (weakness) and PYREXIA (fever of 102.4 degrees Fahrenheit). At the time of the report, ASTHENIA (weakness), CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever of 102.4 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment information was not provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Myalgia
Clinical narrative: feels a little weak; fever of 102.5 and went up 102.9, then 104.2; achiness; fever; uncontrollable shivering; chills; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels a little weak), PAIN (achiness), PYREXIA (fever), CHILLS (uncontrollable shivering) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Transfusion since an unknown date. Concomitant products included LETROZOL, ACYCLOVIR [ACICLOVIR], ALPRAZOLAM (XANAX) and TEMAZEPAM for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 28-Jan-2021, the patient experienced PAIN (achiness), PYREXIA (fever), CHILLS (uncontrollable shivering), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 29-Jan-2021, the patient experienced PYREXIA (fever of 102.5 and went up 102.9, then 104.2). On an unknown date, the patient experienced ASTHENIA (feels a little weak). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 31-Jan-2021, PAIN (achiness), PYREXIA (fever), CHILLS (uncontrollable shivering), CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PYREXIA (fever of 102.5 and went up 102.9, then 104.2) had resolved. At the time of the report, ASTHENIA (feels a little weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 102.5 degree Celsius High, 102.9 degree Celsius High and 104.2 degree Celsius High.         Treatment included ice pack.   This case was linked to MOD-2021-016748 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: feels a little weak; fever of 102.5 and went up 102.9, then 104.2; achiness; fever; uncontrollable shivering; chills; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels a little weak), PAIN (achiness), PYREXIA (fever), CHILLS (uncontrollable shivering) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Transfusion since an unknown date. Concomitant products included LETROZOL, ACYCLOVIR [ACICLOVIR], ALPRAZOLAM (XANAX) and TEMAZEPAM for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 28-Jan-2021, the patient experienced PAIN (achiness), PYREXIA (fever), CHILLS (uncontrollable shivering), CHILLS (chills), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 29-Jan-2021, the patient experienced PYREXIA (fever of 102.5 and went up 102.9, then 104.2). On an unknown date, the patient experienced ASTHENIA (feels a little weak). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 31-Jan-2021, PAIN (achiness), PYREXIA (fever), CHILLS (uncontrollable shivering), CHILLS (chills), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and PYREXIA (fever of 102.5 and went up 102.9, then 104.2) had resolved. At the time of the report, ASTHENIA (feels a little weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 102.5 degree Celsius High, 102.9 degree Celsius High and 104.2 degree Celsius High.         Treatment included ice pack.   This case was linked to MOD-2021-016748 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, AMLODIPINE, PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 19-Apr-2021, the patient experienced FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) had resolved.            Treatment medication was not provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Vaccination site erythema
Clinical narrative: soreness on arm; spot was hot to touch; redness on arm/spreading down the arm a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on arm), FEELING HOT (spot was hot to touch) and VACCINATION SITE ERYTHEMA (redness on arm/spreading down the arm a little bit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness on arm), FEELING HOT (spot was hot to touch) and VACCINATION SITE ERYTHEMA (redness on arm/spreading down the arm a little bit). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (soreness on arm), FEELING HOT (spot was hot to touch) and VACCINATION SITE ERYTHEMA (redness on arm/spreading down the arm a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.     Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up information received on 07-JUN-2021 contains non-significant information.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Vaccination site bruising; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising). At the time of the report, VACCINATION SITE BRUISING (Vaccination site bruising) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications information was not reported. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: follow-up received on 21 may 2021.Additional info received such as event outcome.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pulmonary pain, Sinusitis
Clinical narrative: Really bad sinus infection; Hurting all over his body in lungs and sides; Hurting all over his body in lungs and sides; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Really bad sinus infection), PULMONARY PAIN (Hurting all over his body in lungs and sides) and MYALGIA (Hurting all over his body in lungs and sides) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Congenital cystic kidney disease. Concomitant products included OMEPRAZOLE, AMLODIPINE, VALSARTAN, TRAZODONE and PRAZOSIN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced SINUSITIS (Really bad sinus infection), PULMONARY PAIN (Hurting all over his body in lungs and sides) and MYALGIA (Hurting all over his body in lungs and sides). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (THERAFLU [CHLORPHENAMINE MALEATE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, SINUSITIS (Really bad sinus infection), PULMONARY PAIN (Hurting all over his body in lungs and sides) and MYALGIA (Hurting all over his body in lungs and sides) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product colour issue
Clinical narrative: 1st vaccine looked brown in color.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT COLOUR ISSUE (1st vaccine looked brown in color.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PRODUCT COLOUR ISSUE (1st vaccine looked brown in color.). At the time of the report, PRODUCT COLOUR ISSUE (1st vaccine looked brown in color.) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment medication was reported.   This case was linked to MOD-2021-081240 (Patient Link).
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year-old was administered the first dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old was administered the first dose of Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old was administered the first dose of Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old was administered the first dose of Moderna vaccine) 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 provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She also mentioned that the first shot hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She also mentioned that the first shot hurt) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032MZ0A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.    On 19-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 VACCINATION SITE PAIN (She also mentioned that the first shot hurt). At the time of the report, VACCINATION SITE PAIN (She also mentioned that the first shot hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Tylenol and Ibuprofen were used as both concomitant and treatment medications   This case was linked to US-MODERNATX, INC.-MOD-2021-081232 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081232:CROSSLINKED WITH DOSE 2
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Muscular weakness
Clinical narrative: Two falls after receiving second dose of vaccine; Having jelly legs after receiving second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Two falls after receiving second dose of vaccine) and MUSCULAR WEAKNESS (Having jelly legs after receiving second dose of vaccine) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 002B21A) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM, METOPROLOL, PARACETAMOL (TYLENOL), WARFARIN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced FALL (Two falls after receiving second dose of vaccine) and MUSCULAR WEAKNESS (Having jelly legs after receiving second dose of vaccine). At the time of the report, FALL (Two falls after receiving second dose of vaccine) and MUSCULAR WEAKNESS (Having jelly legs after receiving second dose of vaccine) outcome was unknown. Not Provided          No treatment drugs were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site swelling
Clinical narrative: can't stay awake; slept for 30 hours straight from Saturday to Sunday; size of a baseball popped up at the injection site; it's red and hurts a little bit; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (can't stay awake; slept for 30 hours straight from Saturday to Sunday) and VACCINATION SITE SWELLING (size of a baseball popped up at the injection site; it's red and hurts a little bit) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 032MZ0A) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced SOMNOLENCE (can't stay awake; slept for 30 hours straight from Saturday to Sunday) and VACCINATION SITE SWELLING (size of a baseball popped up at the injection site; it's red and hurts a little bit). At the time of the report, SOMNOLENCE (can't stay awake; slept for 30 hours straight from Saturday to Sunday) and VACCINATION SITE SWELLING (size of a baseball popped up at the injection site; it's red and hurts a little bit) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-081229 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081229:CROSSLINKED WITH DOSE 1
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Bruising below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising below the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Bruising below the injection site). At the time of the report, VACCINATION SITE BRUISING (Bruising below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  Treatment medication was not provided
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Glycosylated haemoglobin increased, Malaise
Clinical narrative: blood sugar has still be all over the place all this time; HgB A1C was reported to be 9.5% while normally it stays around 8%; Was not feeling great after first shot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Was not feeling great after first shot), GLYCOSYLATED HAEMOGLOBIN INCREASED (HgB A1C was reported to be 9.5% while normally it stays around 8%) and BLOOD GLUCOSE INCREASED (blood sugar has still be all over the place all this time) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MALAISE (Was not feeling great after first shot). On 12-Mar-2021, the patient experienced GLYCOSYLATED HAEMOGLOBIN INCREASED (HgB A1C was reported to be 9.5% while normally it stays around 8%). On 19-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar has still be all over the place all this time). At the time of the report, MALAISE (Was not feeling great after first shot), GLYCOSYLATED HAEMOGLOBIN INCREASED (HgB A1C was reported to be 9.5% while normally it stays around 8%) and BLOOD GLUCOSE INCREASED (blood sugar has still be all over the place all this time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment medication was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-081237 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: The Telephone Contact Report form received on 17-MAY-2021.No new information is added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081237:2nd dose of vaccine
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Glycosylated haemoglobin
Clinical narrative: morning sugar was reported to be 600mg/dL; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (morning sugar was reported to be 600mg/dL) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (morning sugar was reported to be 600mg/dL). At the time of the report, BLOOD GLUCOSE INCREASED (morning sugar was reported to be 600mg/dL) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Glycosylated haemoglobin increased: 9.5 % (High) while normally it stays around 8%.. On 19-Apr-2021, Blood glucose: 600 mg/dl (High) increased.         No treatment and concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081236 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081236:1st dose of vaccine
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Bad hives on all over her body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Bad hives on all over her body) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A211A) 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 12-Apr-2021, the patient experienced URTICARIA (Bad hives on all over her body). At the time of the report, URTICARIA (Bad hives on all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Dizziness, Nausea, Vertigo
Clinical narrative: Feelings of passing out/dizziness; room spinning; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feelings of passing out/dizziness), VERTIGO (room spinning) and NAUSEA (nausea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included METFORMIN and ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DIZZINESS (Feelings of passing out/dizziness), VERTIGO (room spinning) and NAUSEA (nausea). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feelings of passing out/dizziness), VERTIGO (room spinning) and NAUSEA (nausea) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Blood pressure measurement: normal (normal) Normal.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Product colour issue, Product quality issue, Wrong technique in product usage process
Clinical narrative: 1st vaccine looked brown in color.; 1st vaccine looked brown in color.; 1st vaccine looked brown in color.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT COLOUR ISSUE (1st vaccine looked brown in color.), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1st vaccine looked brown in color.) and PRODUCT QUALITY ISSUE (1st vaccine looked brown in color.) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 001C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 22-Mar-2021, the patient experienced PRODUCT COLOUR ISSUE (1st vaccine looked brown in color.), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1st vaccine looked brown in color.) and PRODUCT QUALITY ISSUE (1st vaccine looked brown in color.). At the time of the report, PRODUCT COLOUR ISSUE (1st vaccine looked brown in color.), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (1st vaccine looked brown in color.) and PRODUCT QUALITY ISSUE (1st vaccine looked brown in color.) outcome was unknown. Not Provided          No concomitant medications were provided. No Treatment history was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Myalgia, Pyrexia
Clinical narrative: fever; body aches; Feels weak; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (body aches), ASTHENIA (Feels weak) and DECREASED APPETITE (no appetite) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced PYREXIA (fever), MYALGIA (body aches), ASTHENIA (Feels weak) and DECREASED APPETITE (no appetite). Not Provided
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain, Pruritus
Clinical narrative: 2 inch circle rash round on arm near injection; itchiness; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash), PRURITUS (Itchy) and PAIN (Soreness) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash), PRURITUS (Itchy) and PAIN (Soreness). On 08-Apr-2021, VACCINATION SITE RASH (Vaccination site rash), PRURITUS (Itchy) and PAIN (Soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown by the reporter. Treatment medication include Diphenhydramine
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Cough, Dyspnoea, Pain in extremity
Clinical narrative: Asthma attack; shortness of breath; Tightness in chest; coughing; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma attack), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (Tightness in chest), COUGH (coughing) and PAIN IN EXTREMITY (Sore arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (From birth), Postural orthostatic tachycardia syndrome (recent changes in status of chronic condition  with symptoms of fatigue lightheadedness, mental fog) since 2010, Drug allergy (Allergy to Imitrez), Contrast media allergy (CT dye), Drug allergy (Allergy to Zomig) and Drug allergy (Allergy to dioxicycline). Concomitant products included ESTRADIOL for Hormone therapy, ZOLPIDEM TARTRATE (AMBIEN) for Sleep difficult.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ASTHMA (Asthma attack), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (Tightness in chest), COUGH (coughing) and PAIN IN EXTREMITY (Sore arm). On 27-Jan-2021, ASTHMA (Asthma attack) had resolved. At the time of the report, DYSPNOEA (shortness of breath), CHEST DISCOMFORT (Tightness in chest) and COUGH (coughing) had resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       (EMT) advised her to use asthma inhaler. Oxygen and blood pressure were monitored for 30 minutes.   This case was linked to US-MODERNATX, INC.-MOD-2021-081259 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Pt height, weight, race/ethnicity and AE's updated.  Concomitant meds and history also provided.(the response received from the reporter for dose 2) On 02-Jun-2021: Follow up included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081259:2nd dose
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchiness in her left arm; rash in her left arm; swelling in her left arm; redness in her left arm; soreness; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), VACCINATION SITE PRURITUS (itchiness in her left arm), VACCINATION SITE PAIN (sore left arm), VACCINATION SITE ERYTHEMA (rash in her left arm) and VACCINATION SITE SWELLING (swelling in her left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). On 17-Apr-2021, the patient experienced PAIN (soreness). On 19-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness in her left arm), VACCINATION SITE ERYTHEMA (rash in her left arm), VACCINATION SITE SWELLING (swelling in her left arm) and VACCINATION SITE ERYTHEMA (redness in her left arm). The patient was treated with NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency. On 10-Apr-2021, VACCINATION SITE PAIN (sore left arm) had resolved. On 17-Apr-2021, PAIN (soreness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchiness in her left arm), VACCINATION SITE ERYTHEMA (rash in her left arm), VACCINATION SITE SWELLING (swelling in her left arm) and VACCINATION SITE ERYTHEMA (redness in her left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided Treatment for the event included ice presses
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 and received the 1st dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 and received the 1st dose of the Moderna COVID19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 and received the 1st dose of the Moderna COVID19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 and received the 1st dose of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old male) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 014M2CA) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included BUPROPION and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 18-Jul-2021. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 08-Apr-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the vaccine) had resolved. Not Provided          Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep talking
Clinical narrative: Talking in her sleep; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP TALKING (Talking in her sleep) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), ATORVASTATIN, CLONAZEPAM and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SLEEP TALKING (Talking in her sleep). On 18-Apr-2021, SLEEP TALKING (Talking in her sleep) had resolved. Not Provided          No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm), PAIN (pain/sore) and SWELLING (swollen armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swollen arm), PAIN (pain/sore) and SWELLING (swollen armpit). At the time of the report, VACCINATION SITE SWELLING (swollen arm), PAIN (pain/sore) and SWELLING (swollen armpit) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment drug was reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Cough that won't go away; when she coughs her nose runs; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough that won't go away) and RHINORRHOEA (when she coughs her nose runs) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-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 03-Apr-2021, the patient experienced COUGH (Cough that won't go away) and RHINORRHOEA (when she coughs her nose runs). At the time of the report, COUGH (Cough that won't go away) and RHINORRHOEA (when she coughs her nose runs) outcome was unknown. Not Provided          No relevant concomitant medications were reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: The TCR follow up received in which second dose information is added.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Epistaxis, Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), EPISTAXIS (nose bleeding), ASTHENIA (really weak), ILLNESS and DIARRHOEA in a 19-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.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), ASTHENIA (really weak), ILLNESS, DIARRHOEA, VOMITING, CHILLS, PYREXIA (fever), MYALGIA (body aches), HEADACHE, and FATIGUE. On 15-Apr-2021, the patient experienced EPISTAXIS (nose bleedings). On 14-Apr-2021, PAIN IN EXTREMITY (her arm hurt really bad, she couldn't lift her arm after first dose), ASTHENIA (weak), ILLNESS, DIARRHOEA, VOMITING, CHILLS, PYREXIA (fever), MYALGIA (body aches), and FATIGUE outcome was unknown. At the time of the report, EPISTAXIS (nose bleedings), and HEADACHE outcome was unknown. Not Provided.          No medical history were provided and concomitant medications include birth control pills. No treatment information provided