chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Dry mouth, Erythema, Flushing, Peripheral swelling
Clinical narrative: Redness on thumb; Swelling of thumb; Swollen Face; Swollen Nose; Swollen Tongue; Dry Mouth; Dry Eyes; Blurred Vision; Mark on Face; Flushing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swollen Face), SWELLING (Swollen Nose), SWOLLEN TONGUE (Swollen Tongue), DRY MOUTH (Dry Mouth) and DRY EYE (Dry Eyes) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholecystectomy, Appendectomy and Vagotomy. Concurrent medical conditions included Penicillin allergy, Latex allergy and Food allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING FACE (Swollen Face), SWELLING (Swollen Nose), SWOLLEN TONGUE (Swollen Tongue), DRY MOUTH (Dry Mouth), DRY EYE (Dry Eyes), VISION BLURRED (Blurred Vision), RASH (Mark on Face) and FLUSHING (Flushing). On 04-Mar-2021, the patient experienced ERYTHEMA (Redness on thumb) and PERIPHERAL SWELLING (Swelling of thumb). At the time of the report, SWELLING FACE (Swollen Face), SWELLING (Swollen Nose), SWOLLEN TONGUE (Swollen Tongue), DRY MOUTH (Dry Mouth), DRY EYE (Dry Eyes), VISION BLURRED (Blurred Vision), RASH (Mark on Face), FLUSHING (Flushing), ERYTHEMA (Redness on thumb) and PERIPHERAL SWELLING (Swelling of thumb) 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Swelling face, Swollen tongue, Vision blurred
Clinical narrative: Redness on thumb; Swelling of thumb; Swollen Face; Swollen Nose; Swollen Tongue; Dry Mouth; Dry Eyes; Blurred Vision; Mark on Face; Flushing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swollen Face), SWELLING (Swollen Nose), SWOLLEN TONGUE (Swollen Tongue), DRY MOUTH (Dry Mouth) and DRY EYE (Dry Eyes) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholecystectomy, Appendectomy and Vagotomy. Concurrent medical conditions included Penicillin allergy, Latex allergy and Food allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SWELLING FACE (Swollen Face), SWELLING (Swollen Nose), SWOLLEN TONGUE (Swollen Tongue), DRY MOUTH (Dry Mouth), DRY EYE (Dry Eyes), VISION BLURRED (Blurred Vision), RASH (Mark on Face) and FLUSHING (Flushing). On 04-Mar-2021, the patient experienced ERYTHEMA (Redness on thumb) and PERIPHERAL SWELLING (Swelling of thumb). At the time of the report, SWELLING FACE (Swollen Face), SWELLING (Swollen Nose), SWOLLEN TONGUE (Swollen Tongue), DRY MOUTH (Dry Mouth), DRY EYE (Dry Eyes), VISION BLURRED (Blurred Vision), RASH (Mark on Face), FLUSHING (Flushing), ERYTHEMA (Redness on thumb) and PERIPHERAL SWELLING (Swelling of thumb) 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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Chills, Dizziness, Fatigue
Clinical narrative: Missed her 2nd dose; Chills; Fever; Body aches; Fatigue, tiredness; Elevated BP; Dizziness; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated BP), DIZZINESS (Dizziness), ASTHENIA (Weakness), PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose) and CHILLS (Chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (while taking care of patients with Covid-19).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated BP), DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Fatigue, tiredness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose). At the time of the report, BLOOD PRESSURE INCREASED (Elevated BP), DIZZINESS (Dizziness), ASTHENIA (Weakness), PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Fatigue, tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     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 relevant concomitant medications were provided.  The patient reported that she missed her second dose due to death in family and due to severe adverse event (AE) she experienced after first dose of vaccination. The patient reported that she felt like Covid-19 all over again after the vaccination. The patient was inquiring about should she get the second dose of vaccination since it has been >42 days and she was positive for Covid-19 antibodies at the time of reporting.  No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Missed her 2nd dose; Chills; Fever; Body aches; Fatigue, tiredness; Elevated BP; Dizziness; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated BP), DIZZINESS (Dizziness), ASTHENIA (Weakness), PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose) and CHILLS (Chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (while taking care of patients with Covid-19).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated BP), DIZZINESS (Dizziness), ASTHENIA (Weakness), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Fatigue, tiredness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose). At the time of the report, BLOOD PRESSURE INCREASED (Elevated BP), DIZZINESS (Dizziness), ASTHENIA (Weakness), PRODUCT DOSE OMISSION ISSUE (Missed her 2nd dose), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Fatigue, tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     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 relevant concomitant medications were provided.  The patient reported that she missed her second dose due to death in family and due to severe adverse event (AE) she experienced after first dose of vaccination. The patient reported that she felt like Covid-19 all over again after the vaccination. The patient was inquiring about should she get the second dose of vaccination since it has been >42 days and she was positive for Covid-19 antibodies at the time of reporting.  No treatment information was provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm swelling; This spontaneous case was reported by a health care professional and describes the occurrence of PERIPHERAL SWELLING (Arm swelling) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling). At the time of the report, PERIPHERAL SWELLING (Arm swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. The patient  had exercised to get rid of arm swelling.   This case was linked to MOD-2021-215057 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Pain in extremity
Clinical narrative: Lightheadedness; Arm was in pain for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) and PAIN IN EXTREMITY (Arm was in pain for 2 days) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 (Recovering), Diabetic and Hypertension.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIZZINESS (Lightheadedness) and PAIN IN EXTREMITY (Arm was in pain for 2 days). The patient was treated with METFORMIN at an unspecified dose and frequency; GLIPIZIDE at an unspecified dose and frequency and APPLE CIDER VINEGAR at an unspecified dose and frequency. At the time of the report, DIZZINESS (Lightheadedness) and PAIN IN EXTREMITY (Arm was in pain for 2 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) Very high sugar levels in the range of 200.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  The patient reported that the symptoms started about a week after taking the shot. The patient stated that she tried metformin, and glipizide and it did not work but apple cider vinegar was taking it down. The symptoms were ongoing at the time of reporting.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Myalgia, Pain, Pyrexia
Clinical narrative: Positive for COVID-19; coughing; running nose; symptoms worsened with fever of 99.1; soreness at injection site; mild body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for COVID-19), PAIN (mild body aches), COUGH (coughing), RHINORRHOEA (running nose) and PYREXIA (symptoms worsened with fever of 99.1) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), IRON, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), APIXABAN (ELIQUIS), METFORMIN, LEVOTHYROXINE, ROSUVASTATIN, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN/HYDROCHLOROTHIAZIDE), DOCUSATE SODIUM (STOOL SOFTENER), CALCIUM, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), METOPROLOL, POTASSIUM and ASCORBIC ACID, HESPERIDIN, LYSINE, VITIS VINIFERA SEED (VITROCAP) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (mild body aches) and MYALGIA (soreness at injection site). On 11-Mar-2021, the patient experienced COUGH (coughing), RHINORRHOEA (running nose) and PYREXIA (symptoms worsened with fever of 99.1). On 12-Mar-2021, the patient experienced COVID-19 (Positive for COVID-19). The patient was treated with CARVEDILOL (CARVEDIOL) at an unspecified dose and frequency; QUERCETIN at an unspecified dose and frequency; IVERMECTIN at an unspecified dose and frequency; METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and PROBIOTIC 10 at an unspecified dose and frequency. On 15-Mar-2021, PYREXIA (symptoms worsened with fever of 99.1) had resolved. At the time of the report, COVID-19 (Positive for COVID-19), PAIN (mild body aches), COUGH (coughing), RHINORRHOEA (running nose) and MYALGIA (soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, COVID-19: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Medrol dose pak, ivermectin, zinc, probiotic, quercetin.   Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Positive for COVID-19; coughing; running nose; symptoms worsened with fever of 99.1; soreness at injection site; mild body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for COVID-19), PAIN (mild body aches), COUGH (coughing), RHINORRHOEA (running nose) and PYREXIA (symptoms worsened with fever of 99.1) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21H) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), IRON, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), APIXABAN (ELIQUIS), METFORMIN, LEVOTHYROXINE, ROSUVASTATIN, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN/HYDROCHLOROTHIAZIDE), DOCUSATE SODIUM (STOOL SOFTENER), CALCIUM, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), METOPROLOL, POTASSIUM and ASCORBIC ACID, HESPERIDIN, LYSINE, VITIS VINIFERA SEED (VITROCAP) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (mild body aches) and MYALGIA (soreness at injection site). On 11-Mar-2021, the patient experienced COUGH (coughing), RHINORRHOEA (running nose) and PYREXIA (symptoms worsened with fever of 99.1). On 12-Mar-2021, the patient experienced COVID-19 (Positive for COVID-19). The patient was treated with CARVEDILOL (CARVEDIOL) at an unspecified dose and frequency; QUERCETIN at an unspecified dose and frequency; IVERMECTIN at an unspecified dose and frequency; METHYLPREDNISOLONE (MEDROL DOSEPAK) at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and PROBIOTIC 10 at an unspecified dose and frequency. On 15-Mar-2021, PYREXIA (symptoms worsened with fever of 99.1) had resolved. At the time of the report, COVID-19 (Positive for COVID-19), PAIN (mild body aches), COUGH (coughing), RHINORRHOEA (running nose) and MYALGIA (soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, COVID-19: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Medrol dose pak, ivermectin, zinc, probiotic, quercetin.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Upset; Left arm hurts so bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm hurts so bad) and FEELING ABNORMAL (Upset) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left arm hurts so bad). On an unknown date, the patient experienced FEELING ABNORMAL (Upset). At the time of the report, PAIN IN EXTREMITY (Left arm hurts so bad) and FEELING ABNORMAL (Upset) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Diarhhea; Body aches; Bad headaches; Felt very fatigued; Chills; Very tender arm; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Very tender arm), DIARRHOEA (Diarhhea), MYALGIA (Body aches), HEADACHE (Bad headaches) and FATIGUE (Felt very fatigued) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol since 2000. Concomitant products included PRAVASTATIN from 2010 to an unknown date, TAMSULOSIN from 2019 to an unknown date, VITAMIN C [ASCORBIC ACID] from 1990 to an unknown date, MULTIVITAMIN [VITAMINS NOS] and GLUCOSAMINE HYDROCHLORIDE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Low grade fever). On 05-Mar-2021, the patient experienced TENDERNESS (Very tender arm), MYALGIA (Body aches), HEADACHE (Bad headaches), FATIGUE (Felt very fatigued) and CHILLS (Chills). On an unknown date, the patient experienced DIARRHOEA (Diarhhea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, TENDERNESS (Very tender arm), DIARRHOEA (Diarhhea), MYALGIA (Body aches), HEADACHE (Bad headaches), FATIGUE (Felt very fatigued), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved.            This case was linked to MOD-2021-044530 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07 May 2021 contains contact information of the reporter,  patient's demographics, anatomical location of first and second dose, medical history, concomitant medications and onset date of the event fever On 14-Jul-2021: follow-up information recived on 14-jul-2021, non significant follow up.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness
Clinical narrative: Diarhhea; Body aches; Bad headaches; Felt very fatigued; Chills; Very tender arm; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Very tender arm), DIARRHOEA (Diarhhea), MYALGIA (Body aches), HEADACHE (Bad headaches) and FATIGUE (Felt very fatigued) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included High cholesterol since 2000. Concomitant products included PRAVASTATIN from 2010 to an unknown date, TAMSULOSIN from 2019 to an unknown date, VITAMIN C [ASCORBIC ACID] from 1990 to an unknown date, MULTIVITAMIN [VITAMINS NOS] and GLUCOSAMINE HYDROCHLORIDE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Low grade fever). On 05-Mar-2021, the patient experienced TENDERNESS (Very tender arm), MYALGIA (Body aches), HEADACHE (Bad headaches), FATIGUE (Felt very fatigued) and CHILLS (Chills). On an unknown date, the patient experienced DIARRHOEA (Diarhhea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, TENDERNESS (Very tender arm), DIARRHOEA (Diarhhea), MYALGIA (Body aches), HEADACHE (Bad headaches), FATIGUE (Felt very fatigued), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved.            This case was linked to MOD-2021-044530 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07 May 2021 contains contact information of the reporter,  patient's demographics, anatomical location of first and second dose, medical history, concomitant medications and onset date of the event fever On 14-Jul-2021: follow-up information recived on 14-jul-2021, non significant follow up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injections site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injections site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injections site). On 12-Feb-2021, VACCINATION SITE PAIN (Sore arm at injections site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment was taken for first dose event.   This case was linked to MOD-2021-213138 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Ultrasound scan
Clinical narrative: Received the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011j20a and 031l20a) for COVID-19 vaccination.     The patient's past medical history included Spotting vaginal (Spotting in early weeks). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Dec-2020 and the estimated date of delivery was 14-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Ultrasound scan: normal (normal) Normal.         No treatment information was provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Developed shingles) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Developed shingles). At the time of the report, HERPES ZOSTER (Developed shingles) outcome was unknown.            Treatment details included Anti-viral medication.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Herpes zoster, Neck pain
Clinical narrative: lower back pain; chills; fatigue; neck pain; pain exactly like shingle pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), HERPES ZOSTER (pain exactly like shingle pain), BACK PAIN (lower back pain), CHILLS (chills) and FATIGUE (fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (neck pain), HERPES ZOSTER (pain exactly like shingle pain), BACK PAIN (lower back pain), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, NECK PAIN (neck pain), HERPES ZOSTER (pain exactly like shingle pain) and BACK PAIN (lower back pain) had resolved and CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment medications was not provided    Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Vaccination site pain
Clinical narrative: Pregnant; injection site soreness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (injection site soreness) in a 39-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Symphysis pubis dysfunction. Concurrent medical conditions included Allergy to antibiotic (Tetracycline), Thyroid activity decreased (Treatment change: dose doubled due to pregnancy) since 01-Jan-2018, Gestational diabetes (borderline gestastional diabeties) since 02-Mar-2021 and Sleep apnea (Worsening due to pregnancy). Concomitant products included ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), DOCUSATE SODIUM (STOOL SOFTENER) and CALCIUM, MAGNESIUM (CALCIUM + MAGNESIUM) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Aug-2020 and the estimated date of delivery was 01-Jun-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and VACCINATION SITE PAIN (injection site soreness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Mar-2021, VACCINATION SITE PAIN (injection site soreness) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2020, Pregnancy test: positive (Positive) positive. On 02-Mar-2021, Glucose tolerance test: borderline gestastional diabeties (Inconclusive) borderline gestastional diabeties.     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.   On 13 Oct 2020, genetic testing was done (results reported as "none")  Patient had 02 live births and pregnancy end date was reported as 13-Oct-2015 and 27-Dec-2017 respectively.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Pain in extremity, Tinnitus
Clinical narrative: soreness in the arm; Ringing in the ears; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in the ears) and PAIN IN EXTREMITY (soreness in the arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced TINNITUS (Ringing in the ears). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arm). At the time of the report, TINNITUS (Ringing in the ears) and PAIN IN EXTREMITY (soreness in the arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: normal (normal) Normal.     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 relevant concomitant medications were reported. No treatment information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash vesicular
Clinical narrative: Rash on forearms, tummy, back & legs/ progress into blisters; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (Rash on forearms, tummy, back & legs/ progress into blisters) and PAIN IN EXTREMITY (Arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 11-Mar-2021, the patient experienced RASH VESICULAR (Rash on forearms, tummy, back & legs/ progress into blisters). The patient was treated with PREDNISONE for Blistery rash, at a dose of 1 dosage form. On 11-Mar-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, RASH VESICULAR (Rash on forearms, tummy, back & legs/ progress into blisters) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: 42 days might pass; Patient only 17-years-old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17-years-old) and PRODUCT DOSE OMISSION ISSUE (42 days might pass) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17-years-old). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (42 days might pass). On 14-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient only 17-years-old) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (42 days might pass) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow-up received on 21-April-2021.updated event
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Inadequate dose administered due to faulty syringe; Inadequate dose administered due to faulty syringe; A spontaneous report  was received from a consumer concerning a 74-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and Inadequate dose administered due to faulty syringe.  The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 15 Mar 2021, approximately same day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:0001B21A)  intramuscularly for prophylaxis of COVID-19 infection.   On 15 Mar 2021, The patient received Inadequate dose administered due to faulty syringe   Action taken with mRNA-1273 in response to the events was not reported.   The events,Inadequate dose administered due to faulty syringe was considered resolved on 15 Mar 2021,; Reporter's Comments: This report refers to a case of Incorrect dose administered and Syringe issue for mRNA-1273, lot # 0001B21A  with no associated Adverse Events.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Heart rate, Pyrexia, Rash, Rash macular
Clinical narrative: On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced RASH MACULAR (little spot on forehead), RASH (rash on face and chest), ARTHRALGIA (achy joints) and PYREXIA (low grade fever 98.8). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN BAYER) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (little spot on forehead), RASH (rash on face and chest), ARTHRALGIA (achy joints) and PYREXIA (low grade fever 98.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Heart rate: 86 (normal) pulse of 86.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Concomitant medications were not provided
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: itching at injection site; redness "pinky" at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness "pinky" at injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness "pinky" at injection site). At the time of the report, INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness "pinky" at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported No treatment medication was reported
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Really sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Really sore arm) in a 60-year-old female 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) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Really sore arm). At the time of the report, PAIN IN EXTREMITY (Really sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate, Influenza like illness, Malaise
Clinical narrative: Really weak; Really dizzy; Feel like with the flu, but no muscle aches; Not well; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Really weak), DIZZINESS (Really dizzy), INFLUENZA LIKE ILLNESS (Feel like with the flu, but no muscle aches), MALAISE (Not well) and PYREXIA (Fever) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0297AvA) for COVID-19 immunisation.     The patient's past medical history included Atrial fibrillation and Cancer (NOS) (twice). Concurrent medical conditions included Drug intolerance NOS and Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid therapy, METOPROLOL for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Really weak), DIZZINESS (Really dizzy), INFLUENZA LIKE ILLNESS (Feel like with the flu, but no muscle aches), MALAISE (Not well) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Really weak), DIZZINESS (Really dizzy), INFLUENZA LIKE ILLNESS (Feel like with the flu, but no muscle aches), MALAISE (Not well) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) heart rate went up.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant products used included A-fib medication NOS. Patient  have been using the app. The patient reported that last March they had similar symptoms and possibly had COVID-19 since they didn't taste sour cucumbers.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Really weak; Really dizzy; Feel like with the flu, but no muscle aches; Not well; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Really weak), DIZZINESS (Really dizzy), INFLUENZA LIKE ILLNESS (Feel like with the flu, but no muscle aches), MALAISE (Not well) and PYREXIA (Fever) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0297AvA) for COVID-19 immunisation.     The patient's past medical history included Atrial fibrillation and Cancer (NOS) (twice). Concurrent medical conditions included Drug intolerance NOS and Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid therapy, METOPROLOL for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Really weak), DIZZINESS (Really dizzy), INFLUENZA LIKE ILLNESS (Feel like with the flu, but no muscle aches), MALAISE (Not well) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Really weak), DIZZINESS (Really dizzy), INFLUENZA LIKE ILLNESS (Feel like with the flu, but no muscle aches), MALAISE (Not well) and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) heart rate went up.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant products used included A-fib medication NOS. Patient  have been using the app. The patient reported that last March they had similar symptoms and possibly had COVID-19 since they didn't taste sour cucumbers.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: COVID positive after receiving vaccine; high fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID positive after receiving vaccine), PYREXIA (high fever), CHILLS (chills) and FATIGUE (fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MZ0A) for COVID-19 vaccination.     Concomitant products included ACEBUTOLOL, DESVENLAFAXINE SUCCINATE (PRISTIQ), ESTROGENS CONJUGATED (PREMARIN), PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX) and HYDROCHLOROTHIAZIDE (THIAZIDE) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (high fever), CHILLS (chills) and FATIGUE (fatigue). On an unknown date, the patient experienced COVID-19 (COVID positive after receiving vaccine). At the time of the report, COVID-19 (COVID positive after receiving vaccine), PYREXIA (high fever), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: unknown (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, X-ray
Clinical narrative: pain all the way down left leg; joint pain; hip pain; ankle pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain all the way down left leg), ARTHRALGIA (joint pain), ARTHRALGIA (hip pain) and ARTHRALGIA (ankle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain all the way down left leg), ARTHRALGIA (joint pain), ARTHRALGIA (hip pain) and ARTHRALGIA (ankle pain). The patient was treated with TRAMADOL at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain all the way down left leg), ARTHRALGIA (joint pain), ARTHRALGIA (hip pain) and ARTHRALGIA (ankle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: the pain could possibly be (Inconclusive) the pain could possibly be arthritis.         This case was linked to MOD-2021-058614 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: fluid in her right leg; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (fluid in her right leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 73771) for COVID-19 vaccination.    Co-suspect product included non-company product LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    The patient's past medical history included Breast cancer and Chemotherapy NOS on 08-Mar-2021.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LORATADINE (CLARITIN [LORATADINE]) (unknown route) at an unspecified dose. On 12-Mar-2021, the patient experienced OEDEMA PERIPHERAL (fluid in her right leg). At the time of the report, OEDEMA PERIPHERAL (fluid in her right leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included "Chemo" No treatment medications provided by the reporter.   Patient was reported that "the fluid in her right leg" started on 12-Mar-2021 after receiving the vaccine. She elevated her leg and laid down which relieved the swelling for a while. The patient noted that after taking a pill of Claritin the swelling comes back and after elevating her leg and laying down the swelling reduces.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Movement disorder, Musculoskeletal stiffness, Myalgia
Clinical narrative: stiffness; barely able to move; muscle aches; fever of 100.6; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), MOVEMENT DISORDER (barely able to move), MYALGIA (muscle aches), PYREXIA (fever of 100.6) and FATIGUE (Tiredness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-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 04-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), MOVEMENT DISORDER (barely able to move), MYALGIA (muscle aches), PYREXIA (fever of 100.6) and FATIGUE (Tiredness). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), MOVEMENT DISORDER (barely able to move), MYALGIA (muscle aches), PYREXIA (fever of 100.6) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 100.6 (Inconclusive) 100.6.         No treatment information was provided.  No concomitant medications were provided by the reporter.