chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Blood pressure increased, Heart rate abnormal, Heart rate increased, Injection site swelling
Clinical narrative: Blood pressure was 130/70; Pulse rate was 133; 48 hours later injection site swelled up to peach size; Fast heart rate, a dozen times a day; Fluctuating heart rate from 20-30 points, difference from 80-120, not steady; Adverse reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE REACTION (Adverse reaction to the vaccine), TACHYCARDIA (Fast heart rate, a dozen times a day), HEART RATE ABNORMAL (Fluctuating heart rate from 20-30 points, difference from 80-120, not steady), BLOOD PRESSURE INCREASED (Blood pressure was 130/70) and HEART RATE INCREASED (Pulse rate was 133) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction and Epilepsy, unspecified. Concurrent medical conditions included Peanut allergy and Migraine, unspecified. Concomitant products included AMITRIPTYLINE and ORAL CONTRACEPTIVE NOS for an unknown indication.   On 04-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) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ADVERSE REACTION (Adverse reaction to the vaccine). On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (Fast heart rate, a dozen times a day), HEART RATE ABNORMAL (Fluctuating heart rate from 20-30 points, difference from 80-120, not steady) and INJECTION SITE SWELLING (48 hours later injection site swelled up to peach size). On 05-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was 130/70) and HEART RATE INCREASED (Pulse rate was 133). At the time of the report, ADVERSE REACTION (Adverse reaction to the vaccine), TACHYCARDIA (Fast heart rate, a dozen times a day), HEART RATE ABNORMAL (Fluctuating heart rate from 20-30 points, difference from 80-120, not steady), BLOOD PRESSURE INCREASED (Blood pressure was 130/70) and HEART RATE INCREASED (Pulse rate was 133) had not resolved and INJECTION SITE SWELLING (48 hours later injection site swelled up to peach size) outcome was unknown.            Treatment for the events included lab work, EKG and chest x-ray. No results provided. Patient was advised to follow-up with Cardiology.   This case was linked toMOD-2021-068409 (E2B Linked Report).; Sender's Comments:  MOD-2021-068409:CROSSLINKED WITH DOSE 1
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Blood pressure was 130/70; Pulse rate was 133; 48 hours later injection site swelled up to peach size; Fast heart rate, a dozen times a day; Fluctuating heart rate from 20-30 points, difference from 80-120, not steady; Adverse reaction to the vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE REACTION (Adverse reaction to the vaccine), TACHYCARDIA (Fast heart rate, a dozen times a day), HEART RATE ABNORMAL (Fluctuating heart rate from 20-30 points, difference from 80-120, not steady), BLOOD PRESSURE INCREASED (Blood pressure was 130/70) and HEART RATE INCREASED (Pulse rate was 133) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction and Epilepsy, unspecified. Concurrent medical conditions included Peanut allergy and Migraine, unspecified. Concomitant products included AMITRIPTYLINE and ORAL CONTRACEPTIVE NOS for an unknown indication.   On 04-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) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced ADVERSE REACTION (Adverse reaction to the vaccine). On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (Fast heart rate, a dozen times a day), HEART RATE ABNORMAL (Fluctuating heart rate from 20-30 points, difference from 80-120, not steady) and INJECTION SITE SWELLING (48 hours later injection site swelled up to peach size). On 05-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was 130/70) and HEART RATE INCREASED (Pulse rate was 133). At the time of the report, ADVERSE REACTION (Adverse reaction to the vaccine), TACHYCARDIA (Fast heart rate, a dozen times a day), HEART RATE ABNORMAL (Fluctuating heart rate from 20-30 points, difference from 80-120, not steady), BLOOD PRESSURE INCREASED (Blood pressure was 130/70) and HEART RATE INCREASED (Pulse rate was 133) had not resolved and INJECTION SITE SWELLING (48 hours later injection site swelled up to peach size) outcome was unknown.            Treatment for the events included lab work, EKG and chest x-ray. No results provided. Patient was advised to follow-up with Cardiology.   This case was linked toMOD-2021-068409 (E2B Linked Report).; Sender's Comments:  MOD-2021-068409:CROSSLINKED WITH DOSE 1
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low grade fever of 99.2 F for about 12 hours.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever of 99.2 F for about 12 hours.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (low grade fever of 99.2 F for about 12 hours.). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (low grade fever of 99.2 F for about 12 hours.) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 99.2 (High) 99.2 Fever.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-068402 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pain in extremity, Peripheral swelling, Vaccination site discolouration
Clinical narrative: around the injection the size of a cherry had black and blue; gold color; upper arm pain; intense fatigue; swelling on the upper arm about the size of an orange; redness, like tomato red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on the upper arm about the size of an orange), VACCINATION SITE DISCOLOURATION (around the injection the size of a cherry had black and blue), VACCINATION SITE DISCOLOURATION (gold color), PAIN IN EXTREMITY (upper arm pain) and ERYTHEMA (redness, like tomato red) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling on the upper arm about the size of an orange) and ERYTHEMA (redness, like tomato red). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (around the injection the size of a cherry had black and blue), VACCINATION SITE DISCOLOURATION (gold color), PAIN IN EXTREMITY (upper arm pain) and FATIGUE (intense fatigue). The patient was treated with PARACETAMOL (TYLENOL) (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling on the upper arm about the size of an orange), PAIN IN EXTREMITY (upper arm pain), ERYTHEMA (redness, like tomato red) and FATIGUE (intense fatigue) outcome was unknown and VACCINATION SITE DISCOLOURATION (around the injection the size of a cherry had black and blue) and VACCINATION SITE DISCOLOURATION (gold color) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked toMOD-2021-068416 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-068416:Original Case : MOD-2021-068416
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Myalgia
Clinical narrative: Achy body overall; Pain in joints; Temperature 101F; Chills; Pains in muscles; Felt almost like she had kidney infection (no shooting pains); Stomach cramps; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Felt almost like she had kidney infection (no shooting pains)), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), PAIN (Achy body overall) and ARTHRALGIA (Pain in joints) in a 35-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 (No medical history reported).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). On 03-Apr-2021, the patient experienced UNEVALUABLE EVENT (Felt almost like she had kidney infection (no shooting pains)), ABDOMINAL PAIN UPPER (Stomach cramps), PAIN (Achy body overall), ARTHRALGIA (Pain in joints), PYREXIA (Temperature 101F), CHILLS (Chills) and MYALGIA (Pains in muscles). On 06-Apr-2021, ABDOMINAL PAIN UPPER (Stomach cramps), PYREXIA (Temperature 101F) and CHILLS (Chills) had resolved. At the time of the report, UNEVALUABLE EVENT (Felt almost like she had kidney infection (no shooting pains)), PAIN (Achy body overall), ARTHRALGIA (Pain in joints) and MYALGIA (Pains in muscles) had resolved and DIARRHOEA (Diarrhea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment for the events was fluids only, no medications.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Unevaluable event
Clinical narrative: Achy body overall; Pain in joints; Temperature 101F; Chills; Pains in muscles; Felt almost like she had kidney infection (no shooting pains); Stomach cramps; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Felt almost like she had kidney infection (no shooting pains)), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), PAIN (Achy body overall) and ARTHRALGIA (Pain in joints) in a 35-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 (No medical history reported).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). On 03-Apr-2021, the patient experienced UNEVALUABLE EVENT (Felt almost like she had kidney infection (no shooting pains)), ABDOMINAL PAIN UPPER (Stomach cramps), PAIN (Achy body overall), ARTHRALGIA (Pain in joints), PYREXIA (Temperature 101F), CHILLS (Chills) and MYALGIA (Pains in muscles). On 06-Apr-2021, ABDOMINAL PAIN UPPER (Stomach cramps), PYREXIA (Temperature 101F) and CHILLS (Chills) had resolved. At the time of the report, UNEVALUABLE EVENT (Felt almost like she had kidney infection (no shooting pains)), PAIN (Achy body overall), ARTHRALGIA (Pain in joints) and MYALGIA (Pains in muscles) had resolved and DIARRHOEA (Diarrhea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment for the events was fluids only, no medications.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Product administered to patient of inappropriate age
Clinical narrative: Patient is 17-years-old; Irritability; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17-years-old), IRRITABILITY (Irritability) and FATIGUE (Fatigue) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17-years-old), IRRITABILITY (Irritability) and FATIGUE (Fatigue). On 06-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient is 17-years-old) had resolved. At the time of the report, IRRITABILITY (Irritability) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product used was not provided by reporter. Treatment for events was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: follow up information received it does not contain any new information.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills; Muscle pains; Fatigue; Headache; Joint pain; Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Muscle pains), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a 44-year-old male 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 05-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CHILLS (Chills), MYALGIA (Muscle pains), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Mild fever). At the time of the report, CHILLS (Chills), MYALGIA (Muscle pains), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Mild fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment for the events was not provided by the reporter.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills; Muscle pains; Fatigue; Headache; Joint pain; Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Muscle pains), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in a 44-year-old male 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 05-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced CHILLS (Chills), MYALGIA (Muscle pains), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Mild fever). At the time of the report, CHILLS (Chills), MYALGIA (Muscle pains), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain) and PYREXIA (Mild fever) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment for the events was not provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb discomfort
Clinical narrative: Left arm numb and dysfunctional for 36 hours after vaccination; Left arm numb and dysfunctional for 36 hours after vaccination; Cannot move or do anything with left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left arm numb and dysfunctional for 36 hours after vaccination), LIMB DISCOMFORT (Left arm numb and dysfunctional for 36 hours after vaccination) and LIMB DISCOMFORT (Cannot move or do anything with left arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 HYPOAESTHESIA (Left arm numb and dysfunctional for 36 hours after vaccination), LIMB DISCOMFORT (Left arm numb and dysfunctional for 36 hours after vaccination) and LIMB DISCOMFORT (Cannot move or do anything with left arm). At the time of the report, HYPOAESTHESIA (Left arm numb and dysfunctional for 36 hours after vaccination), LIMB DISCOMFORT (Left arm numb and dysfunctional for 36 hours after vaccination) and LIMB DISCOMFORT (Cannot move or do anything with left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not reported.  No treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inappropriate schedule of product administration, Peripheral swelling, Urticaria
Clinical narrative: noticed giant welts over the chest, upper arms, both thighs, and stomach; noticed a bright red coin shape lesion around 3 inches in size.; right arm was swollen; second dose given 42 days after first; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (right arm was swollen), URTICARIA (noticed giant welts over the chest, upper arms, both thighs, and stomach), ERYTHEMA (noticed a bright red coin shape lesion around 3 inches in size.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given 42 days after first) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given 42 days after first). On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (right arm was swollen) and ERYTHEMA (noticed a bright red coin shape lesion around 3 inches in size.). On 04-Mar-2021, the patient experienced URTICARIA (noticed giant welts over the chest, upper arms, both thighs, and stomach). On 17-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given 42 days after first) had resolved. At the time of the report, PERIPHERAL SWELLING (right arm was swollen), URTICARIA (noticed giant welts over the chest, upper arms, both thighs, and stomach) and ERYTHEMA (noticed a bright red coin shape lesion around 3 inches in size.) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) on 05-Apr-2021 for Fever, at an unspecified dose and frequency. On 06-Apr-2021, PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fall
Clinical narrative: kept on falling; couldn't get up; she started feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of FALL (kept on falling), DYSSTASIA (couldn't get up) and DIZZINESS (she started feeling dizzy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney stones, Fibromyalgia and Acid reflux (oesophageal). Concurrent medical conditions included Blood pressure high, High cholesterol, Parkinson's disease, Breast cancer, Arthritis, Osteoarthritis, Neuropathy, Diabetes and Hepatic disease. Concomitant products included GABAPENTIN, INSULIN GLARGINE (BASAGLAR), LISINOPRIL, CARBIDOPA, LEVODOPA, FISH OIL (FISH OIL OMEGA 3), TRAMADOL, EZETIMIBE, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), CARBIDOPA, LEVODOPA (CARBIDOPA + L-DOPA) and ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced DIZZINESS (she started feeling dizzy). On 18-Mar-2021, the patient experienced FALL (kept on falling) and DYSSTASIA (couldn't get up). On 20-Mar-2021, FALL (kept on falling), DYSSTASIA (couldn't get up) and DIZZINESS (she started feeling dizzy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was reported as doctor increased her Parkinson's disease medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-068365 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068365:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: can not describe the symptoms, can not explain the adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (can not describe the symptoms, can not explain the adverse event) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cirrhosis liver (as a pre-existing condition).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ADVERSE DRUG REACTION (can not describe the symptoms, can not explain the adverse event). At the time of the report, ADVERSE DRUG REACTION (can not describe the symptoms, can not explain the adverse event) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had treatment for Cirrhosis in the Liver.    This case was linked toMOD-2021-068314 (E2B Linked Report).; Sender's Comments:  MOD-2021-068314:Cross-linked
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Sneezing
Clinical narrative: started having allergies like sneezing; started having allergies like sneezing and coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SNEEZING (started having allergies like sneezing) and COUGH (started having allergies like sneezing and coughing) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No historical conditions were reported.  Concomitant products included COLESEVELAM HYDROCHLORIDE (WELCHOL) for Acid reflux (oesophageal), MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced SNEEZING (started having allergies like sneezing) and COUGH (started having allergies like sneezing and coughing). At the time of the report, SNEEZING (started having allergies like sneezing) and COUGH (started having allergies like sneezing and coughing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were reported as blood pressure medication, cholesterol medication, anxiety medication and acid reflux medication. No treatment information was reported.  Patient was concerned if she can take her second dose with respect to the events occurred after first dose. Her physician directed her to take her second dose.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Working on scheduling for second dose of Moderna vaccine more than 42 days after first dose; Diagnosed with COVID-19 one week after first dose of Moderna vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Diagnosed with COVID-19 one week after first dose of Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Working on scheduling for second dose of Moderna vaccine more than 42 days after first dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No historical conditions were reported.  Concomitant products included DUTASTERIDE (AVODART), PRAZOSIN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Diagnosed with COVID-19 one week after first dose of Moderna vaccine). On 06-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Working on scheduling for second dose of Moderna vaccine more than 42 days after first dose). At the time of the report, COVID-19 (Diagnosed with COVID-19 one week after first dose of Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Working on scheduling for second dose of Moderna vaccine more than 42 days after first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 06-Feb-2021, the patient was treated with Lilly COVID-19 antibody infusion.   This case was linked to MOD-2021-068455 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Dyspnoea, Fatigue, Myalgia
Clinical narrative: difficulty in taking deep breaths/ Feels like I have to force myself for deep breaths; Pain in the back near kidney area; diarrhea; fatigue; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (difficulty in taking deep breaths/ Feels like I have to force myself for deep breaths), BACK PAIN (Pain in the back near kidney area), DIARRHOEA (diarrhea), FATIGUE (fatigue) and MYALGIA (Muscle pain) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) 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) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DYSPNOEA (difficulty in taking deep breaths/ Feels like I have to force myself for deep breaths), BACK PAIN (Pain in the back near kidney area), DIARRHOEA (diarrhea), FATIGUE (fatigue) and MYALGIA (Muscle pain). At the time of the report, DYSPNOEA (difficulty in taking deep breaths/ Feels like I have to force myself for deep breaths), BACK PAIN (Pain in the back near kidney area), DIARRHOEA (diarrhea), FATIGUE (fatigue) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant medications were not reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: injection arm is really hurting; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (injection arm is really hurting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Cholesterol, Type 2 diabetes mellitus and Reflux gastritis.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (injection arm is really hurting). At the time of the report, PAIN IN EXTREMITY (injection arm is really hurting) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not receive treatment for the events, but she enquired if she can consume Aspirin or Tylenol as treatment.  Concomitant medications were taken for high blood pressure, cholesterol, diabetes type 2 and reflux.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medications were not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Cough, Migraine, Muscular weakness
Clinical narrative: Couldn't grip anything with her hands; Started presenting an excruciating back pain after making a specific movement; 102°F fever; Nausea; Extreme shaking; Migraine; When the fever was high she developed a pretty consistent dry cough; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Extreme shaking), MIGRAINE (Migraine), COUGH (When the fever was high she developed a pretty consistent dry cough), BACK PAIN (Started presenting an excruciating back pain after making a specific movement) and PYREXIA (102°F fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TREMOR (Extreme shaking), MIGRAINE (Migraine), COUGH (When the fever was high she developed a pretty consistent dry cough), PYREXIA (102°F fever) and NAUSEA (Nausea). On 06-Mar-2021, the patient experienced BACK PAIN (Started presenting an excruciating back pain after making a specific movement). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Couldn't grip anything with her hands). The patient was treated with Physical therapy for Back pain. At the time of the report, TREMOR (Extreme shaking), MIGRAINE (Migraine), COUGH (When the fever was high she developed a pretty consistent dry cough), NAUSEA (Nausea) and MUSCULAR WEAKNESS (Couldn't grip anything with her hands) outcome was unknown and BACK PAIN (Started presenting an excruciating back pain after making a specific movement) and PYREXIA (102°F fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 102 (High) 102.         This case was linked to MOD-2021-068265 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Non significant follow up received on 20-MAY-2021, event updated; Sender's Comments:  MOD-2021-068265:Same reporter
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Couldn't grip anything with her hands; Started presenting an excruciating back pain after making a specific movement; 102°F fever; Nausea; Extreme shaking; Migraine; When the fever was high she developed a pretty consistent dry cough; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Extreme shaking), MIGRAINE (Migraine), COUGH (When the fever was high she developed a pretty consistent dry cough), BACK PAIN (Started presenting an excruciating back pain after making a specific movement) and PYREXIA (102°F fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced TREMOR (Extreme shaking), MIGRAINE (Migraine), COUGH (When the fever was high she developed a pretty consistent dry cough), PYREXIA (102°F fever) and NAUSEA (Nausea). On 06-Mar-2021, the patient experienced BACK PAIN (Started presenting an excruciating back pain after making a specific movement). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Couldn't grip anything with her hands). The patient was treated with Physical therapy for Back pain. At the time of the report, TREMOR (Extreme shaking), MIGRAINE (Migraine), COUGH (When the fever was high she developed a pretty consistent dry cough), NAUSEA (Nausea) and MUSCULAR WEAKNESS (Couldn't grip anything with her hands) outcome was unknown and BACK PAIN (Started presenting an excruciating back pain after making a specific movement) and PYREXIA (102°F fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 102 (High) 102.         This case was linked to MOD-2021-068265 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Non significant follow up received on 20-MAY-2021, event updated; Sender's Comments:  MOD-2021-068265:Same reporter
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: body felt very weak; sore throat; running nose; coughing too much; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RHINORRHOEA (running nose), COUGH (coughing too much), ASTHENIA (body felt very weak) and OROPHARYNGEAL PAIN (sore throat) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included OMEPRAZOLE, LORATADINE, PARACETAMOL (TYLENOL) and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced RHINORRHOEA (running nose) and COUGH (coughing too much). On 05-Apr-2021, the patient experienced ASTHENIA (body felt very weak) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, RHINORRHOEA (running nose), COUGH (coughing too much), ASTHENIA (body felt very weak) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown. Not Provided          Reporter stated that the patient did not experience any symptoms after her first dose. Reporter asked on behalf of patient if it was normal to experience these events post vaccination. Patient received treatment as Tylenol and Advil.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: high temperature (104F); convulsion-type chills (could not stop shaking); Headache; sore muscles; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high temperature (104F)), CHILLS (convulsion-type chills (could not stop shaking)), HEADACHE (Headache), MYALGIA (sore muscles) and NAUSEA (nauseous) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (high temperature (104F)), CHILLS (convulsion-type chills (could not stop shaking)), HEADACHE (Headache), MYALGIA (sore muscles) and NAUSEA (nauseous). On 14-Mar-2021, PYREXIA (high temperature (104F)), CHILLS (convulsion-type chills (could not stop shaking)), HEADACHE (Headache), MYALGIA (sore muscles) and NAUSEA (nauseous) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient got vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got vaccine). On 26-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product details was not reported. Treatment details was not reported .   This case was linked to MOD-2021-068453 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up information received on 16 Jun 2021 contains non-significant information - Reporter Address and Patient demographic details were updated. On 19-Jul-2021: Follow-up information received on 19 Jul 2021 contains non-significant information, Patient confirms there were no other adverse event.
Sex: M
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: water blister on one hand after getting the first dose; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (water blister on one hand after getting the first dose) in a male patient of an unknown age 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 was provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLISTER (water blister on one hand after getting the first dose). At the time of the report, BLISTER (water blister on one hand after getting the first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pyrexia
Clinical narrative: fever; Suspected Invalid administration of dose; This spontaneous case was reported by a health care professional and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Suspected Invalid administration of dose) and PYREXIA (fever) in a 62-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 (No relevant medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Suspected Invalid administration of dose). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On 30-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Suspected Invalid administration of dose) had resolved. At the time of the report, PYREXIA (fever) 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.   Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non-Significant Follow up
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: sinus; slight nasal congestion; coughing; fever; positive for covid-19; mildly sore arm; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive for covid-19), SINUSITIS (sinus), COUGH (coughing), PYREXIA (fever) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Overweight.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (headache). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (mildly sore arm). On 03-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive for covid-19). On an unknown date, the patient experienced SINUSITIS (sinus), COUGH (coughing), PYREXIA (fever) and NASAL CONGESTION (slight nasal congestion). On 12-Mar-2021, PAIN IN EXTREMITY (mildly sore arm) had resolved. On 13-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (positive for covid-19), SINUSITIS (sinus), COUGH (coughing), PYREXIA (fever) and NASAL CONGESTION (slight nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Patient reported taking antibiotics (Azithromycin), and acetaminophen (Tylenol).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sinusitis
Clinical narrative: sinus; slight nasal congestion; coughing; fever; positive for covid-19; mildly sore arm; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive for covid-19), SINUSITIS (sinus), COUGH (coughing), PYREXIA (fever) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Overweight.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (headache). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (mildly sore arm). On 03-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive for covid-19). On an unknown date, the patient experienced SINUSITIS (sinus), COUGH (coughing), PYREXIA (fever) and NASAL CONGESTION (slight nasal congestion). On 12-Mar-2021, PAIN IN EXTREMITY (mildly sore arm) had resolved. On 13-Mar-2021, HEADACHE (headache) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (positive for covid-19), SINUSITIS (sinus), COUGH (coughing), PYREXIA (fever) and NASAL CONGESTION (slight nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Patient reported taking antibiotics (Azithromycin), and acetaminophen (Tylenol).
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: high fever after getting the second dose; body aches after getting the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever after getting the second dose) and MYALGIA (body aches after getting the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 PYREXIA (high fever after getting the second dose) and MYALGIA (body aches after getting the second dose). At the time of the report, PYREXIA (high fever after getting the second dose) and MYALGIA (body aches after getting the second dose) outcome was unknown.            Treatment information was not provided. Concomitant medications were not reported.  Action taken with the mRNA-1273 in response to the event is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional information added on 19-May-2021 as no new information.