chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Rash macular, Vaccination site induration
Clinical narrative: Noticed red blotches and rash on arm going from shoulder to elbow; Its painful under the arm, and painful behind arm; Site is swollen and hard; Site is swollen and hard; Lymph node is swollen; Had Headaches; Fever; Had Chills; Had Muscle pain; Felt tired; Had joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Noticed red blotches and rash on arm going from shoulder to elbow), PAIN IN EXTREMITY (Its painful under the arm, and painful behind arm), VACCINATION SITE INDURATION (Site is swollen and hard), HEADACHE (Had Headaches) and PYREXIA (Fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-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) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced HEADACHE (Had Headaches), PYREXIA (Fever), CHILLS (Had Chills), MYALGIA (Had Muscle pain), FATIGUE (Felt tired) and ARTHRALGIA (Had joint pain). On 26-Apr-2021, the patient experienced RASH MACULAR (Noticed red blotches and rash on arm going from shoulder to elbow), PAIN IN EXTREMITY (Its painful under the arm, and painful behind arm), VACCINATION SITE INDURATION (Site is swollen and hard), VACCINATION SITE SWELLING (Site is swollen and hard) and LYMPHADENOPATHY (Lymph node is swollen). The patient was treated with IBUPROFEN on 25-Apr-2021 for Adverse event, at an unspecified dose and frequency. On 26-Apr-2021, HEADACHE (Had Headaches), PYREXIA (Fever), CHILLS (Had Chills), MYALGIA (Had Muscle pain), FATIGUE (Felt tired) and ARTHRALGIA (Had joint pain) had resolved. At the time of the report, RASH MACULAR (Noticed red blotches and rash on arm going from shoulder to elbow), PAIN IN EXTREMITY (Its painful under the arm, and painful behind arm), VACCINATION SITE INDURATION (Site is swollen and hard), VACCINATION SITE SWELLING (Site is swollen and hard) and LYMPHADENOPATHY (Lymph node is swollen) outcome was unknown.            No concomitant Medications were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Noticed red blotches and rash on arm going from shoulder to elbow; Its painful under the arm, and painful behind arm; Site is swollen and hard; Site is swollen and hard; Lymph node is swollen; Had Headaches; Fever; Had Chills; Had Muscle pain; Felt tired; Had joint pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Noticed red blotches and rash on arm going from shoulder to elbow), PAIN IN EXTREMITY (Its painful under the arm, and painful behind arm), VACCINATION SITE INDURATION (Site is swollen and hard), HEADACHE (Had Headaches) and PYREXIA (Fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-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) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced HEADACHE (Had Headaches), PYREXIA (Fever), CHILLS (Had Chills), MYALGIA (Had Muscle pain), FATIGUE (Felt tired) and ARTHRALGIA (Had joint pain). On 26-Apr-2021, the patient experienced RASH MACULAR (Noticed red blotches and rash on arm going from shoulder to elbow), PAIN IN EXTREMITY (Its painful under the arm, and painful behind arm), VACCINATION SITE INDURATION (Site is swollen and hard), VACCINATION SITE SWELLING (Site is swollen and hard) and LYMPHADENOPATHY (Lymph node is swollen). The patient was treated with IBUPROFEN on 25-Apr-2021 for Adverse event, at an unspecified dose and frequency. On 26-Apr-2021, HEADACHE (Had Headaches), PYREXIA (Fever), CHILLS (Had Chills), MYALGIA (Had Muscle pain), FATIGUE (Felt tired) and ARTHRALGIA (Had joint pain) had resolved. At the time of the report, RASH MACULAR (Noticed red blotches and rash on arm going from shoulder to elbow), PAIN IN EXTREMITY (Its painful under the arm, and painful behind arm), VACCINATION SITE INDURATION (Site is swollen and hard), VACCINATION SITE SWELLING (Site is swollen and hard) and LYMPHADENOPATHY (Lymph node is swollen) outcome was unknown.            No concomitant Medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Swollen tongue, Taste disorder
Clinical narrative: Tongue swelling; funny taste of mouth; light headed; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue swelling), TASTE DISORDER (funny taste of mouth) and DIZZINESS (light headed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SWOLLEN TONGUE (Tongue swelling), TASTE DISORDER (funny taste of mouth) and DIZZINESS (light headed). At the time of the report, SWOLLEN TONGUE (Tongue swelling), TASTE DISORDER (funny taste of mouth) and DIZZINESS (light headed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided    This case was linked to US-MODERNATX, INC.-MOD-2021-090190 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090190:Crosslinked case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore for a couple of days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore for a couple of days). At the time of the report, PAIN IN EXTREMITY (arm was sore for a couple of days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported by patient.   This case was linked to US-MODERNATX, INC.-MOD-2021-016969, MOD21-081941 (E2B Linked Report). This case was linked to MOD-2021-090440 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016969: MOD21-081941:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced COVID-19 (contracted COVID). At the time of the report, COVID-19 (contracted COVID) outcome was unknown. Not Provided           No concomitant medication was reported.  Treatment medication included Tx: Inhaler, Zpack, Cough Syrup.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-090465 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090465:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), LORAZEPAM, ATENOLOL, PAROXETINE, ROSUVASTATIN CALCIUM (CRESTOR), QUETIAPINE, CLONAZEPAM, MOMETASONE FUROATE (NASONEX) and LEVOCETIRIZINE for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: arm is real red around where the shot was. It's sore and swollen; real red around where the shot was; arm is real red around where the shot was. It's sore; achy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is real red around where the shot was. It's sore and swollen), VACCINATION SITE ERYTHEMA (real red around where the shot was), VACCINATION SITE PAIN (arm is real red around where the shot was. It's sore) and MYALGIA (achy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025821A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm is real red around where the shot was. It's sore and swollen), VACCINATION SITE ERYTHEMA (real red around where the shot was), VACCINATION SITE PAIN (arm is real red around where the shot was. It's sore) and MYALGIA (achy). At the time of the report, PERIPHERAL SWELLING (arm is real red around where the shot was. It's sore and swollen), VACCINATION SITE ERYTHEMA (real red around where the shot was), VACCINATION SITE PAIN (arm is real red around where the shot was. It's sore) and MYALGIA (achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up information received contains No New Information.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Lethargy, Somnolence, Vaccination site pain
Clinical narrative: Heaviness on the chest; Chest pain; Pain in the injection site; sleepy; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Heaviness on the chest), SOMNOLENCE (sleepy), LETHARGY (Lethargic), CHEST PAIN (Chest pain) and VACCINATION SITE PAIN (Pain in the injection site) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    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 SOMNOLENCE (sleepy), LETHARGY (Lethargic) and VACCINATION SITE PAIN (Pain in the injection site). On 12-Apr-2021, the patient experienced CHEST DISCOMFORT (Heaviness on the chest) and CHEST PAIN (Chest pain). On 09-Apr-2021, VACCINATION SITE PAIN (Pain in the injection site) had resolved. On 10-Apr-2021, SOMNOLENCE (sleepy) and LETHARGY (Lethargic) had resolved. On 23-Apr-2021, CHEST DISCOMFORT (Heaviness on the chest) and CHEST PAIN (Chest pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not take medication to treat symptoms but fasted for 12 hours a couple of days and felt better.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-May-2021 and contains non significant information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Oral mucosal blistering
Clinical narrative: inside of mouth swollen with blisters; left bottom lip bumpy like an orange peel; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (inside of mouth swollen with blisters) and LIP SWELLING (left bottom lip bumpy like an orange peel) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Salivary gland operation (left salivary gland cut out) in October 2019. Concomitant products included DOXYCYCLINE for Eye disorder.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ORAL MUCOSAL BLISTERING (inside of mouth swollen with blisters) and LIP SWELLING (left bottom lip bumpy like an orange peel). At the time of the report, ORAL MUCOSAL BLISTERING (inside of mouth swollen with blisters) and LIP SWELLING (left bottom lip bumpy like an orange peel) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment given included paste to put on mouth sores.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Eye pain, Fatigue, Feeling abnormal
Clinical narrative: Does not have her period; Felt awful; Aches down her entire spine; Aches down her hip flexor; Aches down her knee; Aches down her elbow; Aches down her shoulders; Laid in bed at 7.30pm because of dizziness; Pain behind both eyes; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Laid in bed at 7.30pm because of dizziness), EYE PAIN (Pain behind both eyes), SPINAL PAIN (Aches down her entire spine), FEELING ABNORMAL (Felt awful) and OLIGOMENORRHOEA (Does not have her period) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021 at 9:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021 at 5:00 PM, the patient experienced FATIGUE (Feeling tired). On 14-Apr-2021 at 7:30 PM, the patient experienced DIZZINESS (Laid in bed at 7.30pm because of dizziness) and EYE PAIN (Pain behind both eyes). On 15-Apr-2021 at 3:00 AM, the patient experienced SPINAL PAIN (Aches down her entire spine). 15-Apr-2021 at 3:00 AM, the patient experienced ARTHRALGIA (Aches down her hip flexor), ARTHRALGIA (Aches down her knee), ARTHRALGIA (Aches down her elbow) and ARTHRALGIA (Aches down her shoulders). On 15-Apr-2021 at 7:30 AM, the patient experienced FEELING ABNORMAL (Felt awful). On 18-Apr-2021, the patient experienced OLIGOMENORRHOEA (Does not have her period). At the time of the report, DIZZINESS (Laid in bed at 7.30pm because of dizziness), SPINAL PAIN (Aches down her entire spine), FEELING ABNORMAL (Felt awful), FATIGUE (Feeling tired), ARTHRALGIA (Aches down her knee), ARTHRALGIA (Aches down her elbow) and ARTHRALGIA (Aches down her shoulders) outcome was unknown and EYE PAIN (Pain behind both eyes), OLIGOMENORRHOEA (Does not have her period) and ARTHRALGIA (Aches down her hip flexor) had not resolved.            She took pregnancy test and was negative. No concomitant medications reported. Treatment information was not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea, Spinal pain
Clinical narrative: Does not have her period; Felt awful; Aches down her entire spine; Aches down her hip flexor; Aches down her knee; Aches down her elbow; Aches down her shoulders; Laid in bed at 7.30pm because of dizziness; Pain behind both eyes; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Laid in bed at 7.30pm because of dizziness), EYE PAIN (Pain behind both eyes), SPINAL PAIN (Aches down her entire spine), FEELING ABNORMAL (Felt awful) and OLIGOMENORRHOEA (Does not have her period) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021 at 9:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021 at 5:00 PM, the patient experienced FATIGUE (Feeling tired). On 14-Apr-2021 at 7:30 PM, the patient experienced DIZZINESS (Laid in bed at 7.30pm because of dizziness) and EYE PAIN (Pain behind both eyes). On 15-Apr-2021 at 3:00 AM, the patient experienced SPINAL PAIN (Aches down her entire spine). 15-Apr-2021 at 3:00 AM, the patient experienced ARTHRALGIA (Aches down her hip flexor), ARTHRALGIA (Aches down her knee), ARTHRALGIA (Aches down her elbow) and ARTHRALGIA (Aches down her shoulders). On 15-Apr-2021 at 7:30 AM, the patient experienced FEELING ABNORMAL (Felt awful). On 18-Apr-2021, the patient experienced OLIGOMENORRHOEA (Does not have her period). At the time of the report, DIZZINESS (Laid in bed at 7.30pm because of dizziness), SPINAL PAIN (Aches down her entire spine), FEELING ABNORMAL (Felt awful), FATIGUE (Feeling tired), ARTHRALGIA (Aches down her knee), ARTHRALGIA (Aches down her elbow) and ARTHRALGIA (Aches down her shoulders) outcome was unknown and EYE PAIN (Pain behind both eyes), OLIGOMENORRHOEA (Does not have her period) and ARTHRALGIA (Aches down her hip flexor) had not resolved.            She took pregnancy test and was negative. No concomitant medications reported. Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: arm was sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was sore for a couple of days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (arm was sore for a couple of days). At the time of the report, MYALGIA (arm was sore for a couple of days) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-016969, MOD21-081941 (E2B Linked Report). This case was linked to MOD-2021-090431 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016969: MOD21-081941:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Ear discomfort, SARS-CoV-2 test, Suffocation feeling
Clinical narrative: Suffocating sensation; Cannot breath deeply, difficulty breathing; Sensation of having an insect in the ear; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SUFFOCATION FEELING (Suffocating sensation), DYSPNOEA (Cannot breath deeply, difficulty breathing) and EAR DISCOMFORT (Sensation of having an insect in the ear) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic shock. Concurrent medical conditions included Asthmatic. Concomitant products included MONTELUKAST for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced SUFFOCATION FEELING (Suffocating sensation), DYSPNOEA (Cannot breath deeply, difficulty breathing) and EAR DISCOMFORT (Sensation of having an insect in the ear). At the time of the report, SUFFOCATION FEELING (Suffocating sensation), DYSPNOEA (Cannot breath deeply, difficulty breathing) and EAR DISCOMFORT (Sensation of having an insect in the ear) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: results not provided Results not provided. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, X-ray: results not provided Results not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient went to emergency room (ER), where a computed tomography (CT) scan, X-Ray diagnosis were made. The patient spoke with different doctors, Clinical, Cardiologist and Pneumologist. She was given medication but symptoms did not subside. She took Montelukast, Prednisone, Albuterol spray and Alprazolam. to treat symptoms.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Suffocating sensation; Cannot breath deeply, difficulty breathing; Sensation of having an insect in the ear; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SUFFOCATION FEELING (Suffocating sensation), DYSPNOEA (Cannot breath deeply, difficulty breathing) and EAR DISCOMFORT (Sensation of having an insect in the ear) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic shock. Concurrent medical conditions included Asthmatic. Concomitant products included MONTELUKAST for an unknown indication.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced SUFFOCATION FEELING (Suffocating sensation), DYSPNOEA (Cannot breath deeply, difficulty breathing) and EAR DISCOMFORT (Sensation of having an insect in the ear). At the time of the report, SUFFOCATION FEELING (Suffocating sensation), DYSPNOEA (Cannot breath deeply, difficulty breathing) and EAR DISCOMFORT (Sensation of having an insect in the ear) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: results not provided Results not provided. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, X-ray: results not provided Results not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient went to emergency room (ER), where a computed tomography (CT) scan, X-Ray diagnosis were made. The patient spoke with different doctors, Clinical, Cardiologist and Pneumologist. She was given medication but symptoms did not subside. She took Montelukast, Prednisone, Albuterol spray and Alprazolam. to treat symptoms.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test positive
Clinical narrative: Tested Positive for COVID-19; Sick with COVID-19 symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19) and ILLNESS (Sick with COVID-19 symptoms) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced ILLNESS (Sick with COVID-19 symptoms). On 22-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested Positive for COVID-19) and ILLNESS (Sick with COVID-19 symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: significant follow-up (events stop date has been updated)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Shivering; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Shivering) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced CHILLS (Shivering). At the time of the report, CHILLS (Shivering) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included Reflux medication and Ashtma medication when needed. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090371, US-MODERNATX, INC.-MOD-2021-090451 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up document added 27-May-2021 contains non significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090371:Son's case US-MODERNATX, INC.-MOD-2021-090451:Dose 2 case
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Insomnia, Loss of personal independence in daily activities, Pyrexia, Vaccination site pain
Clinical narrative: tingling sensation of the injection arm; not able to perform daily routine activities; lack of sleep; left arm has no strength like before; shooting pain over the shoulder, back, arm, hand of injection arm; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PARAESTHESIA (tingling sensation of the injection arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to perform daily routine activities), INSOMNIA (lack of sleep), ASTHENIA (left arm has no strength like before ) and VACCINATION SITE PAIN (shooting pain over the shoulder, back, arm, hand of injection arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PARAESTHESIA (tingling sensation of the injection arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to perform daily routine activities), INSOMNIA (lack of sleep), ASTHENIA (left arm has no strength like before ), VACCINATION SITE PAIN (shooting pain over the shoulder, back, arm, hand of injection arm) and PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 21-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PARAESTHESIA (tingling sensation of the injection arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to perform daily routine activities), INSOMNIA (lack of sleep), ASTHENIA (left arm has no strength like before ) and VACCINATION SITE PAIN (shooting pain over the shoulder, back, arm, hand of injection arm) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information included muscle relaxants.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site paraesthesia
Clinical narrative: tingling sensation of the injection arm; not able to perform daily routine activities; lack of sleep; left arm has no strength like before; shooting pain over the shoulder, back, arm, hand of injection arm; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PARAESTHESIA (tingling sensation of the injection arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to perform daily routine activities), INSOMNIA (lack of sleep), ASTHENIA (left arm has no strength like before ) and VACCINATION SITE PAIN (shooting pain over the shoulder, back, arm, hand of injection arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PARAESTHESIA (tingling sensation of the injection arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to perform daily routine activities), INSOMNIA (lack of sleep), ASTHENIA (left arm has no strength like before ), VACCINATION SITE PAIN (shooting pain over the shoulder, back, arm, hand of injection arm) and PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 21-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PARAESTHESIA (tingling sensation of the injection arm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not able to perform daily routine activities), INSOMNIA (lack of sleep), ASTHENIA (left arm has no strength like before ) and VACCINATION SITE PAIN (shooting pain over the shoulder, back, arm, hand of injection arm) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Treatment information included muscle relaxants.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Itchiness; Bigger bump; Red (bump); bumpy at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), RASH (Bigger bump), VACCINATION SITE ERYTHEMA (Red (bump)) and VACCINATION SITE SWELLING (bumpy at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red (bump)) and VACCINATION SITE SWELLING (bumpy at injection site). On 26-Apr-2021, the patient experienced PRURITUS (Itchiness) and RASH (Bigger bump). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness), RASH (Bigger bump), VACCINATION SITE ERYTHEMA (Red (bump)) and VACCINATION SITE SWELLING (bumpy at injection site) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. No Relevant concomitant medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up TCR received on 27-MAY-2021 and declined the follow up.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chest pain, Cough, Dyspnoea, Fatigue
Clinical narrative: Was sick less then two weeks after my vaccine; Runny nose; Congested; Bone ache; Tired; Cough; Difficult breathing not severe; Sore throat; Pain in front of the chest; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DYSPNOEA (Difficult breathing not severe), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Pain in front of the chest) and RHINORRHOEA (Runny nose) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy (Advil) and Drug allergy (ibuprofen). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) and OXYMETAZOLINE HYDROCHLORIDE (ZICAM [OXYMETAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced CHEST PAIN (Pain in front of the chest). On 24-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 25-Apr-2021, the patient experienced COUGH (Cough), DYSPNOEA (Difficult breathing not severe), BONE PAIN (Bone ache) and FATIGUE (Tired). On 26-Apr-2021, the patient experienced RHINORRHOEA (Runny nose) and NASAL CONGESTION (Congested). On an unknown date, the patient experienced ILLNESS (Was sick less then two weeks after my vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and EMERGEN C at an unspecified dose and frequency. At the time of the report, COUGH (Cough), DYSPNOEA (Difficult breathing not severe), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Pain in front of the chest), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congested), BONE PAIN (Bone ache), ILLNESS (Was sick less then two weeks after my vaccine) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-090661 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Newevent were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090661:Case of son
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Was sick less then two weeks after my vaccine; Runny nose; Congested; Bone ache; Tired; Cough; Difficult breathing not severe; Sore throat; Pain in front of the chest; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DYSPNOEA (Difficult breathing not severe), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Pain in front of the chest) and RHINORRHOEA (Runny nose) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Drug allergy (Advil) and Drug allergy (ibuprofen). Concomitant products included LORATADINE (CLARITIN [LORATADINE]) and OXYMETAZOLINE HYDROCHLORIDE (ZICAM [OXYMETAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced CHEST PAIN (Pain in front of the chest). On 24-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 25-Apr-2021, the patient experienced COUGH (Cough), DYSPNOEA (Difficult breathing not severe), BONE PAIN (Bone ache) and FATIGUE (Tired). On 26-Apr-2021, the patient experienced RHINORRHOEA (Runny nose) and NASAL CONGESTION (Congested). On an unknown date, the patient experienced ILLNESS (Was sick less then two weeks after my vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and EMERGEN C at an unspecified dose and frequency. At the time of the report, COUGH (Cough), DYSPNOEA (Difficult breathing not severe), OROPHARYNGEAL PAIN (Sore throat), CHEST PAIN (Pain in front of the chest), RHINORRHOEA (Runny nose), NASAL CONGESTION (Congested), BONE PAIN (Bone ache), ILLNESS (Was sick less then two weeks after my vaccine) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-090661 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Newevent were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090661:Case of son
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Headache, Myalgia
Clinical narrative: Felt drained; Low grade fever; Extreme headache; Body aches; Felt fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt drained), PYREXIA (Low grade fever), HEADACHE (Extreme headache), MYALGIA (Body aches) and FATIGUE (Felt fatigued) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-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) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ASTHENIA (Felt drained), PYREXIA (Low grade fever), HEADACHE (Extreme headache), MYALGIA (Body aches) and FATIGUE (Felt fatigued). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Felt drained), PYREXIA (Low grade fever), HEADACHE (Extreme headache), MYALGIA (Body aches) and FATIGUE (Felt fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 -101.9 (High) 99.9 -101.9 F.         No relevant concomitant medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Felt drained; Low grade fever; Extreme headache; Body aches; Felt fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt drained), PYREXIA (Low grade fever), HEADACHE (Extreme headache), MYALGIA (Body aches) and FATIGUE (Felt fatigued) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-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) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ASTHENIA (Felt drained), PYREXIA (Low grade fever), HEADACHE (Extreme headache), MYALGIA (Body aches) and FATIGUE (Felt fatigued). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Felt drained), PYREXIA (Low grade fever), HEADACHE (Extreme headache), MYALGIA (Body aches) and FATIGUE (Felt fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 -101.9 (High) 99.9 -101.9 F.         No relevant concomitant medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash pruritic
Clinical narrative: Itchy rash at back of left arm; itching; rash; itchy rash at the back of the right arm; Odd rash on back of both hands after the first dose; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021. The most recent information was received on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash at the back of the right arm), PRURITUS (itching), RASH PRURITIC (Itchy rash at back of left arm), RASH (Odd rash on back of both hands after the first dose) and RASH (rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SOTALOL, RIVAROXABAN (XARELTO), TIMOLOL and KETOROLAC for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced RASH (Odd rash on back of both hands after the first dose). On 26-Apr-2021, the patient experienced RASH PRURITIC (itchy rash at the back of the right arm). On 06-May-2021, the patient experienced PRURITUS (itching) and RASH (rash). On an unknown date, the patient experienced RASH PRURITIC (Itchy rash at back of left arm). At the time of the report, RASH PRURITIC (itchy rash at the back of the right arm), PRURITUS (itching), RASH PRURITIC (Itchy rash at back of left arm), RASH (Odd rash on back of both hands after the first dose) and RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Patient states she had a reaction of a rash on her hands she has never seen before after the first shot and also with the second shot that has not cleared but is fading. Patient has stopped using latex gloves.   This case was linked to MOD21-080705 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: follow-up doc attached on 24 May2021 in which concomitant medication is updated. On 23-Jun-2021: Additional information received on 23-JUNE-2021; Sender's Comments:  MOD21-080705:CrossLinked case
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pruritus
Clinical narrative: Itching in her throat; Myalgia; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in her throat), MYALGIA (Myalgia) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PRURITUS (Itching in her throat), MYALGIA (Myalgia) and FATIGUE (Tiredness). On 26-Apr-2021, PRURITUS (Itching in her throat), MYALGIA (Myalgia) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Pain in extremity
Clinical narrative: nose bleed; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed) and PAIN IN EXTREMITY (sore arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN for Coagulation disorder NOS, METOPROLOL TARTRATE (METOPROLOL XL) for Hypertension, PANTOPRAZOLE for Stomach discomfort.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Apr-2021, the patient experienced EPISTAXIS (nose bleed). On 25-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, EPISTAXIS (nose bleed) outcome was unknown. Not Provided      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 medical history, lab data, and treatment medications are provided