chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Slightly tired; Pain where the needle went in for the injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Pain where the needle went in for the injection) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Acute pancreatitis (Idiopathic reoccurring acute pancreatitis). Concurrent medical conditions included Hashimoto's disease, Atherosclerosis, Gastroesophageal reflux disease, Hypoglycemia, Heart disorder, Vitamin D deficiency, Joint ache and Digestion impaired. Concomitant products included DOCUSATE SODIUM (COLACE) for Digestion impaired, OMEPRAZOLE for GERD, ACETYLSALICYLIC ACID (ASPIRIN 81), UBIDECARENONE (COQ 10) and FISH OIL (OMEGA 3 [FISH OIL]) for Heart disease, unspecified, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE (GLUCOSAMINE AND CHONDROITIN) for Joint ache, ROSUVASTATIN for Sclerosis multiple, LEVOTHYROXINE SODIUM (UNITHROID) for Thyroid disorder NOS, VITAMIN D3 for Vitamin D deficiency.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Pain where the needle went in for the injection). At the time of the report, FATIGUE (Slightly tired) and VACCINATION SITE PAIN (Pain where the needle went in for the injection) outcome was unknown.        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.   Treatment information was not provided for the first dose.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Hyperhidrosis, Pyrexia
Clinical narrative: Upset stomach; Sweaty; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Sweaty) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045V21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa). Concomitant products included DULOXETINE, GABAPENTIN, MELOXICAM, ATORVASTATIN, VITAMIN D NOS and LISINOPRIL 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 an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Sweaty) and PYREXIA (Fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), HYPERHIDROSIS (Sweaty) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient treatment medication also includes antacids.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received and vaccination facility information was added.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Chills, Insulin resistance, Night sweats, Pyrexia
Clinical narrative: Insulin resistance; Chills; Fever; Arm Soreness; Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), INSULIN RESISTANCE (Insulin resistance), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm Soreness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21 and 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN LISPRO (HUMALOG), AMLODIPINE and ATORVASTATIN for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced NIGHT SWEATS (Night sweats), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm Soreness). On an unknown date, the patient experienced INSULIN RESISTANCE (Insulin resistance). The patient was treated with INSULIN LISPRO (HUMALOG) at an unspecified dose and frequency. On 20-May-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. On 22-May-2021, VACCINATION SITE PAIN (Arm Soreness) had resolved. At the time of the report, NIGHT SWEATS (Night sweats) and INSULIN RESISTANCE (Insulin resistance) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Blood glucose: increased (High) more than 300. On 22-May-2021, Blood glucose: 376 High. On an unknown date, Blood glucose: 306 High.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Insulin resistance; Chills; Fever; Arm Soreness; Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), INSULIN RESISTANCE (Insulin resistance), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm Soreness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21 and 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN LISPRO (HUMALOG), AMLODIPINE and ATORVASTATIN for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced NIGHT SWEATS (Night sweats), CHILLS (Chills), PYREXIA (Fever) and VACCINATION SITE PAIN (Arm Soreness). On an unknown date, the patient experienced INSULIN RESISTANCE (Insulin resistance). The patient was treated with INSULIN LISPRO (HUMALOG) at an unspecified dose and frequency. On 20-May-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. On 22-May-2021, VACCINATION SITE PAIN (Arm Soreness) had resolved. At the time of the report, NIGHT SWEATS (Night sweats) and INSULIN RESISTANCE (Insulin resistance) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Blood glucose: increased (High) more than 300. On 22-May-2021, Blood glucose: 376 High. On an unknown date, Blood glucose: 306 High.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Swelling
Clinical narrative: underarm was in pain; chills; underarm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), SWELLING (underarm was swollen) and AXILLARY PAIN (underarm was in pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced CHILLS (chills) and SWELLING (underarm was swollen). On an unknown date, the patient experienced AXILLARY PAIN (underarm was in pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, CHILLS (chills), SWELLING (underarm was swollen) and AXILLARY PAIN (underarm was in pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: Missed window for second dose; Moderna arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Moderna arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed window for second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced VACCINATION COMPLICATION (Moderna arm). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed window for second dose). At the time of the report, VACCINATION COMPLICATION (Moderna arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed window for second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Product administration error) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042b21a) for COVID-19 vaccination. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Product administration error). On 05-May-2021, PRODUCT ADMINISTRATION ERROR (Product administration error) 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. Concomitant product use was unknown by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat after the second dose; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat after the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat after the second dose). At the time of the report, OROPHARYNGEAL PAIN (sore throat after the second dose) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Arthritis pain intensified; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis pain intensified) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Arthritis pain intensified). At the time of the report, ARTHRITIS (Arthritis pain intensified) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant was reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeding disorder, Headache, Malaise
Clinical narrative: dizzy; can't eat; I got my 2nd shot 10 days ago and I'm still sick; headache; nauseous; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FEEDING DISORDER (can't eat), MALAISE (I got my 2nd shot 10 days ago and I'm still sick), HEADACHE (headache) and NAUSEA (nauseous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DIZZINESS (dizzy), FEEDING DISORDER (can't eat), MALAISE (I got my 2nd shot 10 days ago and I'm still sick), HEADACHE (headache), NAUSEA (nauseous) and CHILLS (chills). At the time of the report, DIZZINESS (dizzy), FEEDING DISORDER (can't eat), MALAISE (I got my 2nd shot 10 days ago and I'm still sick), HEADACHE (headache), NAUSEA (nauseous) and CHILLS (chills) outcome was unknown.            No concomitant product information is provided  No treatment product information is provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: dizzy; can't eat; I got my 2nd shot 10 days ago and I'm still sick; headache; nauseous; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FEEDING DISORDER (can't eat), MALAISE (I got my 2nd shot 10 days ago and I'm still sick), HEADACHE (headache) and NAUSEA (nauseous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DIZZINESS (dizzy), FEEDING DISORDER (can't eat), MALAISE (I got my 2nd shot 10 days ago and I'm still sick), HEADACHE (headache), NAUSEA (nauseous) and CHILLS (chills). At the time of the report, DIZZINESS (dizzy), FEEDING DISORDER (can't eat), MALAISE (I got my 2nd shot 10 days ago and I'm still sick), HEADACHE (headache), NAUSEA (nauseous) and CHILLS (chills) outcome was unknown.            No concomitant product information is provided  No treatment product information is provided   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Back pain, Body temperature, Erythema
Clinical narrative: Loss of taste; lower back felt like someone tore them off; redness; Unusual taste; Feeling hot; Flushing; Rash; her hips felt like someone tore them off; severe arm pain; fever of 100.3F; fatigue; Vomiting; headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), BACK PAIN (lower back felt like someone tore them off), ERYTHEMA (redness), TASTE DISORDER (Unusual taste) and FEELING HOT (Feeling hot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contraception. Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for Birth control.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced AGEUSIA (Loss of taste), BACK PAIN (lower back felt like someone tore them off), ERYTHEMA (redness), TASTE DISORDER (Unusual taste), FEELING HOT (Feeling hot), FLUSHING (Flushing), RASH (Rash), ARTHRALGIA (her hips felt like someone tore them off), VACCINATION SITE PAIN (severe arm pain), PYREXIA (fever of 100.3F), FATIGUE (fatigue), VOMITING (Vomiting), HEADACHE (headache) and NAUSEA (Nausea). On 25-May-2021, AGEUSIA (Loss of taste), BACK PAIN (lower back felt like someone tore them off), ERYTHEMA (redness), TASTE DISORDER (Unusual taste), FEELING HOT (Feeling hot), FLUSHING (Flushing), RASH (Rash), ARTHRALGIA (her hips felt like someone tore them off), VACCINATION SITE PAIN (severe arm pain), PYREXIA (fever of 100.3F), FATIGUE (fatigue), VOMITING (Vomiting), HEADACHE (headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Body temperature: 100.3 (High) 100.3F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Treatment information was reported.   This case was linked to MOD-2021-162977 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow Up received, contains Non-Significant information, Email added. On 30-Jul-2021: Follow up received and contains Significant FU : Patient information, Concomitant medications and Event outcome date and outcome were updated.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Flushing, Headache, Nausea
Clinical narrative: Loss of taste; lower back felt like someone tore them off; redness; Unusual taste; Feeling hot; Flushing; Rash; her hips felt like someone tore them off; severe arm pain; fever of 100.3F; fatigue; Vomiting; headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), BACK PAIN (lower back felt like someone tore them off), ERYTHEMA (redness), TASTE DISORDER (Unusual taste) and FEELING HOT (Feeling hot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contraception. Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for Birth control.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced AGEUSIA (Loss of taste), BACK PAIN (lower back felt like someone tore them off), ERYTHEMA (redness), TASTE DISORDER (Unusual taste), FEELING HOT (Feeling hot), FLUSHING (Flushing), RASH (Rash), ARTHRALGIA (her hips felt like someone tore them off), VACCINATION SITE PAIN (severe arm pain), PYREXIA (fever of 100.3F), FATIGUE (fatigue), VOMITING (Vomiting), HEADACHE (headache) and NAUSEA (Nausea). On 25-May-2021, AGEUSIA (Loss of taste), BACK PAIN (lower back felt like someone tore them off), ERYTHEMA (redness), TASTE DISORDER (Unusual taste), FEELING HOT (Feeling hot), FLUSHING (Flushing), RASH (Rash), ARTHRALGIA (her hips felt like someone tore them off), VACCINATION SITE PAIN (severe arm pain), PYREXIA (fever of 100.3F), FATIGUE (fatigue), VOMITING (Vomiting), HEADACHE (headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Body temperature: 100.3 (High) 100.3F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Treatment information was reported.   This case was linked to MOD-2021-162977 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow Up received, contains Non-Significant information, Email added. On 30-Jul-2021: Follow up received and contains Significant FU : Patient information, Concomitant medications and Event outcome date and outcome were updated.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Taste disorder, Vaccination site pain, Vomiting
Clinical narrative: Loss of taste; lower back felt like someone tore them off; redness; Unusual taste; Feeling hot; Flushing; Rash; her hips felt like someone tore them off; severe arm pain; fever of 100.3F; fatigue; Vomiting; headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste), BACK PAIN (lower back felt like someone tore them off), ERYTHEMA (redness), TASTE DISORDER (Unusual taste) and FEELING HOT (Feeling hot) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contraception. Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for Birth control.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced AGEUSIA (Loss of taste), BACK PAIN (lower back felt like someone tore them off), ERYTHEMA (redness), TASTE DISORDER (Unusual taste), FEELING HOT (Feeling hot), FLUSHING (Flushing), RASH (Rash), ARTHRALGIA (her hips felt like someone tore them off), VACCINATION SITE PAIN (severe arm pain), PYREXIA (fever of 100.3F), FATIGUE (fatigue), VOMITING (Vomiting), HEADACHE (headache) and NAUSEA (Nausea). On 25-May-2021, AGEUSIA (Loss of taste), BACK PAIN (lower back felt like someone tore them off), ERYTHEMA (redness), TASTE DISORDER (Unusual taste), FEELING HOT (Feeling hot), FLUSHING (Flushing), RASH (Rash), ARTHRALGIA (her hips felt like someone tore them off), VACCINATION SITE PAIN (severe arm pain), PYREXIA (fever of 100.3F), FATIGUE (fatigue), VOMITING (Vomiting), HEADACHE (headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Body temperature: 100.3 (High) 100.3F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Treatment information was reported.   This case was linked to MOD-2021-162977 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow Up received, contains Non-Significant information, Email added. On 30-Jul-2021: Follow up received and contains Significant FU : Patient information, Concomitant medications and Event outcome date and outcome were updated.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.            Concomitant medications and Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Cytology, Dyspnoea, Full blood count, SARS-CoV-2 test
Clinical narrative: Shortness of breath; This spontaneous case was reported by a physician and describes the occurrence of DYSPNOEA (Shortness of breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lung cancer in 2007 and Lung cancer recurrent (Relapse in 2010 treated with radiation. In remission since.). Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension, Restless leg syndrome, Tobacco user, Neuropathy and Hyperlipidemia. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), GABAPENTIN, IRBESARTAN, ROPINIROLE, INSULIN GLARGINE (LANTUS), METOPROLOL and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2021, Computerised tomogram: other (abnormal) CT scan of chest showed vague ground-glass opacities left lung base possibly representing pneumonitis or atelectasis. Confluent right hilar lymphadenopathy and a large effusion was seen.. On 16-May-2021, Cytology: other (Inconclusive) Cytology was significant for reactive mesothelial cells and negative for any malignancy.. On 16-May-2021, Full blood count: other (normal) Result: normal. On 16-May-2021, SARS-CoV-2 test: other (Negative) Result: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2021-162971 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Constipation, Dizziness, Fatigue, Peripheral coldness
Clinical narrative: Left hand turned cold for 2 days; Very less thirst; Reduced urine output; Constipation; Sleep disturbance and sleep pattern changed; Vision disturbance; Difficulty focussing; Dreams frequency has increased and are more lucid; Pain at injection site; Fatigue; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), CONSTIPATION (Constipation) and DIZZINESS (Light headedness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002179) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced DIZZINESS (Light headedness). On an unknown date, the patient experienced PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), CONSTIPATION (Constipation), SLEEP DISORDER (Sleep disturbance and sleep pattern changed), VISUAL IMPAIRMENT (Vision disturbance), VISION BLURRED (Difficulty focussing), ABNORMAL DREAMS (Dreams frequency has increased and are more lucid), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue). On 21-May-2021, SLEEP DISORDER (Sleep disturbance and sleep pattern changed) had resolved. At the time of the report, PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), VISUAL IMPAIRMENT (Vision disturbance), VISION BLURRED (Difficulty focussing), ABNORMAL DREAMS (Dreams frequency has increased and are more lucid), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue) outcome was unknown and CONSTIPATION (Constipation) and DIZZINESS (Light headedness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported  No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Thirst decreased, Urine output decreased, Vaccination site pain, Vision blurred
Clinical narrative: Left hand turned cold for 2 days; Very less thirst; Reduced urine output; Constipation; Sleep disturbance and sleep pattern changed; Vision disturbance; Difficulty focussing; Dreams frequency has increased and are more lucid; Pain at injection site; Fatigue; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), CONSTIPATION (Constipation) and DIZZINESS (Light headedness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002179) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced DIZZINESS (Light headedness). On an unknown date, the patient experienced PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), CONSTIPATION (Constipation), SLEEP DISORDER (Sleep disturbance and sleep pattern changed), VISUAL IMPAIRMENT (Vision disturbance), VISION BLURRED (Difficulty focussing), ABNORMAL DREAMS (Dreams frequency has increased and are more lucid), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue). On 21-May-2021, SLEEP DISORDER (Sleep disturbance and sleep pattern changed) had resolved. At the time of the report, PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), VISUAL IMPAIRMENT (Vision disturbance), VISION BLURRED (Difficulty focussing), ABNORMAL DREAMS (Dreams frequency has increased and are more lucid), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue) outcome was unknown and CONSTIPATION (Constipation) and DIZZINESS (Light headedness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported  No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Left hand turned cold for 2 days; Very less thirst; Reduced urine output; Constipation; Sleep disturbance and sleep pattern changed; Vision disturbance; Difficulty focussing; Dreams frequency has increased and are more lucid; Pain at injection site; Fatigue; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), CONSTIPATION (Constipation) and DIZZINESS (Light headedness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002179) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced DIZZINESS (Light headedness). On an unknown date, the patient experienced PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), CONSTIPATION (Constipation), SLEEP DISORDER (Sleep disturbance and sleep pattern changed), VISUAL IMPAIRMENT (Vision disturbance), VISION BLURRED (Difficulty focussing), ABNORMAL DREAMS (Dreams frequency has increased and are more lucid), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue). On 21-May-2021, SLEEP DISORDER (Sleep disturbance and sleep pattern changed) had resolved. At the time of the report, PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), VISUAL IMPAIRMENT (Vision disturbance), VISION BLURRED (Difficulty focussing), ABNORMAL DREAMS (Dreams frequency has increased and are more lucid), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue) outcome was unknown and CONSTIPATION (Constipation) and DIZZINESS (Light headedness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported  No treatment information was provided
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Back pain, Body temperature, Condition aggravated
Clinical narrative: overall "fog-like" feeling; arm swollen; bright red rash under injection; fatigue; headache; joint pain in hips; bright red rash under injection site; puking; It was worse; Lost of taste; Face was swollen; Night sweats; Arm pain; joint pain in lower back; rash hot to the touch; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Arm pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for Birth control.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-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 PYREXIA (pyrexia). On 18-May-2021, the patient experienced CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Arm pain). 18-May-2021, the patient experienced BACK PAIN (joint pain in lower back), VACCINATION SITE WARMTH (rash hot to the touch), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE RASH (bright red rash under injection), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain in hips), VACCINATION SITE ERYTHEMA (bright red rash under injection site) and VOMITING (puking). On an unknown date, the patient experienced FEELING ABNORMAL (overall "fog-like" feeling). At the time of the report, CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Arm pain), BACK PAIN (joint pain in lower back), VACCINATION SITE WARMTH (rash hot to the touch), FEELING ABNORMAL (overall "fog-like" feeling), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE RASH (bright red rash under injection), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain in hips), VACCINATION SITE ERYTHEMA (bright red rash under injection site), VOMITING (puking) and PYREXIA (pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 104 (High) 104.         Treatment information not provided.   This case was linked to MOD-2021-162904 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Significant follow up added on 30-Jul-2021 and updated patient demographics, Added Concomitant medication and new event.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Night sweats, Pain in extremity
Clinical narrative: overall "fog-like" feeling; arm swollen; bright red rash under injection; fatigue; headache; joint pain in hips; bright red rash under injection site; puking; It was worse; Lost of taste; Face was swollen; Night sweats; Arm pain; joint pain in lower back; rash hot to the touch; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Arm pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for Birth control.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-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 PYREXIA (pyrexia). On 18-May-2021, the patient experienced CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Arm pain). 18-May-2021, the patient experienced BACK PAIN (joint pain in lower back), VACCINATION SITE WARMTH (rash hot to the touch), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE RASH (bright red rash under injection), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain in hips), VACCINATION SITE ERYTHEMA (bright red rash under injection site) and VOMITING (puking). On an unknown date, the patient experienced FEELING ABNORMAL (overall "fog-like" feeling). At the time of the report, CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Arm pain), BACK PAIN (joint pain in lower back), VACCINATION SITE WARMTH (rash hot to the touch), FEELING ABNORMAL (overall "fog-like" feeling), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE RASH (bright red rash under injection), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain in hips), VACCINATION SITE ERYTHEMA (bright red rash under injection site), VOMITING (puking) and PYREXIA (pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 104 (High) 104.         Treatment information not provided.   This case was linked to MOD-2021-162904 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Significant follow up added on 30-Jul-2021 and updated patient demographics, Added Concomitant medication and new event.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Swelling face, Vaccination site erythema, Vaccination site rash
Clinical narrative: overall "fog-like" feeling; arm swollen; bright red rash under injection; fatigue; headache; joint pain in hips; bright red rash under injection site; puking; It was worse; Lost of taste; Face was swollen; Night sweats; Arm pain; joint pain in lower back; rash hot to the touch; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Arm pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for Birth control.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-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 PYREXIA (pyrexia). On 18-May-2021, the patient experienced CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Arm pain). 18-May-2021, the patient experienced BACK PAIN (joint pain in lower back), VACCINATION SITE WARMTH (rash hot to the touch), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE RASH (bright red rash under injection), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain in hips), VACCINATION SITE ERYTHEMA (bright red rash under injection site) and VOMITING (puking). On an unknown date, the patient experienced FEELING ABNORMAL (overall "fog-like" feeling). At the time of the report, CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Arm pain), BACK PAIN (joint pain in lower back), VACCINATION SITE WARMTH (rash hot to the touch), FEELING ABNORMAL (overall "fog-like" feeling), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE RASH (bright red rash under injection), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain in hips), VACCINATION SITE ERYTHEMA (bright red rash under injection site), VOMITING (puking) and PYREXIA (pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 104 (High) 104.         Treatment information not provided.   This case was linked to MOD-2021-162904 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Significant follow up added on 30-Jul-2021 and updated patient demographics, Added Concomitant medication and new event.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth, Vomiting
Clinical narrative: overall "fog-like" feeling; arm swollen; bright red rash under injection; fatigue; headache; joint pain in hips; bright red rash under injection site; puking; It was worse; Lost of taste; Face was swollen; Night sweats; Arm pain; joint pain in lower back; rash hot to the touch; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Arm pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for Birth control.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-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 PYREXIA (pyrexia). On 18-May-2021, the patient experienced CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Arm pain). 18-May-2021, the patient experienced BACK PAIN (joint pain in lower back), VACCINATION SITE WARMTH (rash hot to the touch), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE RASH (bright red rash under injection), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain in hips), VACCINATION SITE ERYTHEMA (bright red rash under injection site) and VOMITING (puking). On an unknown date, the patient experienced FEELING ABNORMAL (overall "fog-like" feeling). At the time of the report, CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Arm pain), BACK PAIN (joint pain in lower back), VACCINATION SITE WARMTH (rash hot to the touch), FEELING ABNORMAL (overall "fog-like" feeling), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE RASH (bright red rash under injection), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain in hips), VACCINATION SITE ERYTHEMA (bright red rash under injection site), VOMITING (puking) and PYREXIA (pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 104 (High) 104.         Treatment information not provided.   This case was linked to MOD-2021-162904 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Significant follow up added on 30-Jul-2021 and updated patient demographics, Added Concomitant medication and new event.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Disturbance in attention, Dyspnoea, Facial pain, Fatigue
Clinical narrative: jaw pain; facial pain; cough; harder time breathing; out of focus; weekness in leg; fatigue; redness at covid vaccination injections site; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN JAW (jaw pain), FACIAL PAIN (facial pain), COUGH (cough), DYSPNOEA (harder time breathing) and DISTURBANCE IN ATTENTION (out of focus) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MACITENTAN for Pulmonary hypertension.    Concurrent medical conditions included Pulmonary hypertension. Concomitant products included TREPROSTINIL SODIUM (TYVASO) and TADALAFIL for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and MACITENTAN (Oral) 10 mg. On an unknown date, the patient experienced PAIN IN JAW (jaw pain), FACIAL PAIN (facial pain), COUGH (cough), DYSPNOEA (harder time breathing), DISTURBANCE IN ATTENTION (out of focus), MUSCULAR WEAKNESS (weekness in leg), FATIGUE (fatigue) and INJECTION SITE ERYTHEMA (redness at covid vaccination injections site). At the time of the report, PAIN IN JAW (jaw pain), FACIAL PAIN (facial pain), COUGH (cough), DYSPNOEA (harder time breathing), DISTURBANCE IN ATTENTION (out of focus), MUSCULAR WEAKNESS (weekness in leg), FATIGUE (fatigue) and INJECTION SITE ERYTHEMA (redness at covid vaccination injections site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.