chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported. No concomitant medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia, Pain in extremity
Clinical narrative: sore arm; Chills; Headache; swollen lymph nodes; Fever; Myalgia; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache), LYMPHADENOPATHY (swollen lymph nodes) and PYREXIA (Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache), LYMPHADENOPATHY (swollen lymph nodes), PYREXIA (Fever) and MYALGIA (Myalgia). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache), LYMPHADENOPATHY (swollen lymph nodes), PYREXIA (Fever) and MYALGIA (Myalgia) outcome was unknown.            N o relevant concomitant medications reported.  Action taken with mRNA-123 is not applicable.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore arm; Chills; Headache; swollen lymph nodes; Fever; Myalgia; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache), LYMPHADENOPATHY (swollen lymph nodes) and PYREXIA (Fever) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache), LYMPHADENOPATHY (swollen lymph nodes), PYREXIA (Fever) and MYALGIA (Myalgia). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache), LYMPHADENOPATHY (swollen lymph nodes), PYREXIA (Fever) and MYALGIA (Myalgia) outcome was unknown.            N o relevant concomitant medications reported.  Action taken with mRNA-123 is not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Sore at injection site; Fatigue; Chills; Waking up in the middle of the night feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at injection site), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Waking up in the middle of the night feeling feverish) 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 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore at injection site), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Waking up in the middle of the night feeling feverish). On 06-Feb-2021, VACCINATION SITE PAIN (Sore at injection site), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Waking up in the middle of the night feeling feverish) had resolved.            Concomitant medications were not provided. Treatment information was not provided. Action taken with mRNA-123 is not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Rash macular, Vaccination site erythema
Clinical narrative: bump at the injection site it was about 1 inch in diameter; Red ring; large Blotchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (bump at the injection site it was about 1 inch in diameter), VACCINATION SITE ERYTHEMA (Red ring) and RASH MACULAR (large Blotchy at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE MASS (bump at the injection site it was about 1 inch in diameter), VACCINATION SITE ERYTHEMA (Red ring) and RASH MACULAR (large Blotchy at injection site). At the time of the report, INJECTION SITE MASS (bump at the injection site it was about 1 inch in diameter), VACCINATION SITE ERYTHEMA (Red ring) and RASH MACULAR (large Blotchy at injection site) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided.  No Treatments were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Eating disorder, Faeces soft, Interchange of vaccine products
Clinical narrative: Cramping; urgency; Either liquid or extremely soft stools; Weight loss; Inability to eat; Chose not to get a Moderna vaccine, but in early May got Johnson and Johson; Diarrhea/ Urgency; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea/ Urgency), ABDOMINAL PAIN (Cramping), DIARRHOEA (urgency), FAECES SOFT (Either liquid or extremely soft stools) and WEIGHT DECREASED (Weight loss) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 05-Mar-2021, the patient experienced DIARRHOEA (Diarrhea/ Urgency). In May 2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Chose not to get a Moderna vaccine, but in early May got Johnson and Johson). On an unknown date, the patient experienced ABDOMINAL PAIN (Cramping), DIARRHOEA (urgency), FAECES SOFT (Either liquid or extremely soft stools), WEIGHT DECREASED (Weight loss) and EATING DISORDER (Inability to eat). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of 1 dosage form twice a day. At the time of the report, DIARRHOEA (Diarrhea/ Urgency), ABDOMINAL PAIN (Cramping), DIARRHOEA (urgency), FAECES SOFT (Either liquid or extremely soft stools), WEIGHT DECREASED (Weight loss), EATING DISORDER (Inability to eat) and INTERCHANGE OF VACCINE PRODUCTS (Chose not to get a Moderna vaccine, but in early May got Johnson and Johson) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-Jul-2021 contains significant information. The vaccine Batch/Lot number was updated. New events were added.
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Cramping; urgency; Either liquid or extremely soft stools; Weight loss; Inability to eat; Chose not to get a Moderna vaccine, but in early May got Johnson and Johson; Diarrhea/ Urgency; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea/ Urgency), ABDOMINAL PAIN (Cramping), DIARRHOEA (urgency), FAECES SOFT (Either liquid or extremely soft stools) and WEIGHT DECREASED (Weight loss) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 05-Mar-2021, the patient experienced DIARRHOEA (Diarrhea/ Urgency). In May 2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Chose not to get a Moderna vaccine, but in early May got Johnson and Johson). On an unknown date, the patient experienced ABDOMINAL PAIN (Cramping), DIARRHOEA (urgency), FAECES SOFT (Either liquid or extremely soft stools), WEIGHT DECREASED (Weight loss) and EATING DISORDER (Inability to eat). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of 1 dosage form twice a day. At the time of the report, DIARRHOEA (Diarrhea/ Urgency), ABDOMINAL PAIN (Cramping), DIARRHOEA (urgency), FAECES SOFT (Either liquid or extremely soft stools), WEIGHT DECREASED (Weight loss), EATING DISORDER (Inability to eat) and INTERCHANGE OF VACCINE PRODUCTS (Chose not to get a Moderna vaccine, but in early May got Johnson and Johson) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-Jul-2021 contains significant information. The vaccine Batch/Lot number was updated. New events were added.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chest discomfort, Dizziness, Flushing, Headache
Clinical narrative: Tightness in chest; Sleepiness; Temperature; Flushed; Grogginess; Headache; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), SOMNOLENCE (Sleepiness), BODY TEMPERATURE INCREASED (Temperature), FLUSHING (Flushed) and DIZZINESS (Grogginess) in a 74-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.     Concomitant products included CARVEDILOL, LEVOTHYROXINE SODIUM (SYNTHROID), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K), LANSOPRAZOLE (PREVACID), HYDRALAZINE, ENALAPRIL and CLONIDINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE PAIN (Injection site soreness). On 03-Mar-2021, the patient experienced CHEST DISCOMFORT (Tightness in chest), SOMNOLENCE (Sleepiness), BODY TEMPERATURE INCREASED (Temperature), FLUSHING (Flushed), DIZZINESS (Grogginess) and HEADACHE (Headache). On 05-Mar-2021, CHEST DISCOMFORT (Tightness in chest), SOMNOLENCE (Sleepiness), BODY TEMPERATURE INCREASED (Temperature), FLUSHING (Flushed) and DIZZINESS (Grogginess) had resolved. At the time of the report, INJECTION SITE PAIN (Injection site soreness) had resolved and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature increased: high (High) Body temperature increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the soreness included icing of the site   This case was linked to MOD-2021-036424 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Somnolence
Clinical narrative: Tightness in chest; Sleepiness; Temperature; Flushed; Grogginess; Headache; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), SOMNOLENCE (Sleepiness), BODY TEMPERATURE INCREASED (Temperature), FLUSHING (Flushed) and DIZZINESS (Grogginess) in a 74-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.     Concomitant products included CARVEDILOL, LEVOTHYROXINE SODIUM (SYNTHROID), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K), LANSOPRAZOLE (PREVACID), HYDRALAZINE, ENALAPRIL and CLONIDINE for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE PAIN (Injection site soreness). On 03-Mar-2021, the patient experienced CHEST DISCOMFORT (Tightness in chest), SOMNOLENCE (Sleepiness), BODY TEMPERATURE INCREASED (Temperature), FLUSHING (Flushed), DIZZINESS (Grogginess) and HEADACHE (Headache). On 05-Mar-2021, CHEST DISCOMFORT (Tightness in chest), SOMNOLENCE (Sleepiness), BODY TEMPERATURE INCREASED (Temperature), FLUSHING (Flushed) and DIZZINESS (Grogginess) had resolved. At the time of the report, INJECTION SITE PAIN (Injection site soreness) had resolved and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature increased: high (High) Body temperature increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the soreness included icing of the site   This case was linked to MOD-2021-036424 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Resting Heart Rate is 125; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Resting Heart Rate is 125) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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 13-Mar-2021, the patient experienced HEART RATE INCREASED (Resting Heart Rate is 125). At the time of the report, HEART RATE INCREASED (Resting Heart Rate is 125) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Heart rate: 125 (High) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Pain
Clinical narrative: Little more like a flu; (Second shot)body ache a little stronger; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Little more like a flu), PAIN ((Second shot)body ache a little stronger) and FATIGUE (Tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-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. On 31-Jan-2021, the patient experienced INFLUENZA (Little more like a flu), PAIN ((Second shot)body ache a little stronger) and FATIGUE (Tired). At the time of the report, INFLUENZA (Little more like a flu), PAIN ((Second shot)body ache a little stronger) and FATIGUE (Tired) outcome was unknown.             No relevant concomitant medications were reported. Treatment details was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-025543 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Short lived soreness of arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (short lived soreness of arm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine)(Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (short lived soreness of arm). At the time of the report, PAIN IN EXTREMITY (short lived soreness of arm) had resolved.            No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K202A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 19-Nov-2020. Concomitant products included THYROID (ARMOUR THYROID) and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). The patient was treated with ONDANSETRON (ZOFRAN MELT) at an unspecified dose and frequency; PARACETAMOL (TYLENOL EXTRA-STRENGTH) at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) at an unspecified dose and frequency. On 08-Jan-2021, PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included zofran, ginger, extra strength tylenol, Claritin D,.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-029213.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Lactose intolerance
Clinical narrative: Patient developed lactose intolerance; This spontaneous case was reported by a consumer and describes the occurrence of LACTOSE INTOLERANCE (Patient developed lactose intolerance) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012LM0A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LACTOSE INTOLERANCE (Patient developed lactose intolerance). At the time of the report, LACTOSE INTOLERANCE (Patient developed lactose intolerance) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Decreased appetite
Clinical narrative: Lack of appetite; Aches; Sleepiness; Lethargy; weakness; Body chills; Sharp pain in her joints (shoulders and knees); Nauseated; fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lack of appetite), PAIN (Aches), SOMNOLENCE (Sleepiness), LETHARGY (Lethargy) and ASTHENIA (weakness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced DECREASED APPETITE (Lack of appetite), PAIN (Aches), SOMNOLENCE (Sleepiness), LETHARGY (Lethargy), ASTHENIA (weakness), CHILLS (Body chills), ARTHRALGIA (Sharp pain in her joints (shoulders and knees)), NAUSEA (Nauseated) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse reaction, at a dose of 1 dosage form once a day. On 08-Mar-2021, DECREASED APPETITE (Lack of appetite), SOMNOLENCE (Sleepiness), ASTHENIA (weakness), CHILLS (Body chills), ARTHRALGIA (Sharp pain in her joints (shoulders and knees)), NAUSEA (Nauseated) and PYREXIA (fever) had resolved. At the time of the report, PAIN (Aches) and LETHARGY (Lethargy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: 99-102 degrees f (High) fever.         No concomitant medications reported.    This case was linked to MOD-2021-037190 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: Lack of appetite; Aches; Sleepiness; Lethargy; weakness; Body chills; Sharp pain in her joints (shoulders and knees); Nauseated; fever; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lack of appetite), PAIN (Aches), SOMNOLENCE (Sleepiness), LETHARGY (Lethargy) and ASTHENIA (weakness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced DECREASED APPETITE (Lack of appetite), PAIN (Aches), SOMNOLENCE (Sleepiness), LETHARGY (Lethargy), ASTHENIA (weakness), CHILLS (Body chills), ARTHRALGIA (Sharp pain in her joints (shoulders and knees)), NAUSEA (Nauseated) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse reaction, at a dose of 1 dosage form once a day. On 08-Mar-2021, DECREASED APPETITE (Lack of appetite), SOMNOLENCE (Sleepiness), ASTHENIA (weakness), CHILLS (Body chills), ARTHRALGIA (Sharp pain in her joints (shoulders and knees)), NAUSEA (Nauseated) and PYREXIA (fever) had resolved. At the time of the report, PAIN (Aches) and LETHARGY (Lethargy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Body temperature: 99-102 degrees f (High) fever.         No concomitant medications reported.    This case was linked to MOD-2021-037190 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. No medical history reported. Concomitant products included HYDROCHLOROTHIAZIDE and IRBESARTAN for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Mild headache) outcome was unknown. Action taken with mRNA-1273 in response to the event  was  not applicable. This case was linked to MOD-2021-020629 (E2B Linked Report).; Sender's Comments:  MOD-2021-020629:Same patient, 2nd dose
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: lactating; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPOSURE VIA BREAST MILK (lactating) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (lactating). At the time of the report, EXPOSURE VIA BREAST MILK (lactating) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported.   This case was linked to MOD-2021-032368 (Parent-Child Link).   See case MOD-2021-032368 for details regarding the child case.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema, Vaccination site swelling
Clinical narrative: chills; left arm has been very swollen; red ever since; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), VACCINATION SITE SWELLING (left arm has been very swollen) and VACCINATION SITE ERYTHEMA (red ever since) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (chills), VACCINATION SITE SWELLING (left arm has been very swollen) and VACCINATION SITE ERYTHEMA (red ever since). On 11-Mar-2021, CHILLS (chills) had resolved. At the time of the report, VACCINATION SITE SWELLING (left arm has been very swollen) and VACCINATION SITE ERYTHEMA (red ever since) had not resolved.            Concomitant medication includes heart medications but no new medications. No treatment details were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache
Clinical narrative: Cough; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Neck surgery (Surgery on neck 3 times). Concurrent medical conditions included Emphysema.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced COUGH (Cough) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Cough) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment include ice, warm and Coricidin.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Breast tenderness, Heat exhaustion, Pyrexia
Clinical narrative: Swelling in the left breast; Tenderness of Breast; Heat Generation on breast; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (Swelling in the left breast), BREAST TENDERNESS (Tenderness of Breast), HEAT EXHAUSTION (Heat Generation on breast) and PYREXIA (Fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 006M20A) 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 BREAST SWELLING (Swelling in the left breast), BREAST TENDERNESS (Tenderness of Breast), HEAT EXHAUSTION (Heat Generation on breast) and PYREXIA (Fever). The patient was treated with IBUPROFEN at a dose of 600 milligram and PARACETAMOL (TYLENOL) at a dose of 500 milligram. On 14-Mar-2021, BREAST SWELLING (Swelling in the left breast), BREAST TENDERNESS (Tenderness of Breast), HEAT EXHAUSTION (Heat Generation on breast) and PYREXIA (Fever) had resolved.            Concomitant medication included past natal vitamins.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia
Clinical narrative: felt weak; chills; muscles hurt all over; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), CHILLS (chills) and MYALGIA (muscles hurt all over) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ASTHENIA (felt weak), CHILLS (chills) and MYALGIA (muscles hurt all over). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 11-Mar-2021, ASTHENIA (felt weak), CHILLS (chills) and MYALGIA (muscles hurt all over) had resolved.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Updated contact information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Hypersensitivity reaction; Swelling of the arm of the injection; Itchiness of the arm of the injection; Redness of the arm of the injection; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE SWELLING (Swelling of the arm of the injection), VACCINATION SITE PRURITUS (Itchiness of the arm of the injection) and VACCINATION SITE ERYTHEMA (Redness of the arm of the injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE SWELLING (Swelling of the arm of the injection), VACCINATION SITE PRURITUS (Itchiness of the arm of the injection) and VACCINATION SITE ERYTHEMA (Redness of the arm of the injection). At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE SWELLING (Swelling of the arm of the injection), VACCINATION SITE PRURITUS (Itchiness of the arm of the injection) and VACCINATION SITE ERYTHEMA (Redness of the arm of the injection) 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.   Concomitant medications were not reported Treatment information were not provided
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Vaccination site pain, Vomiting
Clinical narrative: tired; can throw up anytime; nauseated; pain in his arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in his arm of injection), FATIGUE (tired), VOMITING (can throw up anytime) and NAUSEA (nauseated) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, VENLAFAXINE HYDROCHLORIDE (FLAVIX), SIMVASTATIN, INSULIN GLARGINE (LANTUS), GABAPENTIN and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in his arm of injection). On 13-Mar-2021, the patient experienced FATIGUE (tired), VOMITING (can throw up anytime) and NAUSEA (nauseated). At the time of the report, VACCINATION SITE PAIN (pain in his arm of injection), FATIGUE (tired), VOMITING (can throw up anytime) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment taken by the patient.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headaches predominantly; More pan in places where she usually has pain, in back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (More pan in places where she usually has pain, in back) and HEADACHE (Headaches predominantly) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (More pan in places where she usually has pain, in back) and HEADACHE (Headaches predominantly). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2-3 times, qd. At the time of the report, PAIN (More pan in places where she usually has pain, in back) had resolved and HEADACHE (Headaches predominantly) outcome was unknown.          .
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hangover, Increased appetite, Irritability
Clinical narrative: Diarrhea; Sleepy; Hungry; He was irritable; Light weight chills; Nausea; Live hangover; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), INCREASED APPETITE (Hungry), HANGOVER (Live hangover) and IRRITABILITY (He was irritable) in a male patient of an unknown age 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 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HANGOVER (Live hangover). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), INCREASED APPETITE (Hungry), IRRITABILITY (He was irritable), CHILLS (Light weight chills) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), INCREASED APPETITE (Hungry), HANGOVER (Live hangover), CHILLS (Light weight chills) and NAUSEA (Nausea) outcome was unknown and IRRITABILITY (He was irritable) had resolved.            Concomitant product use was not provided.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-160354 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21 May 2021 contains details on: Events( weight chills and diarrhea were added as events). He received 2nd shot on 08 Apr 2021.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Somnolence
Clinical narrative: Diarrhea; Sleepy; Hungry; He was irritable; Light weight chills; Nausea; Live hangover; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), INCREASED APPETITE (Hungry), HANGOVER (Live hangover) and IRRITABILITY (He was irritable) in a male patient of an unknown age 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 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HANGOVER (Live hangover). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), INCREASED APPETITE (Hungry), IRRITABILITY (He was irritable), CHILLS (Light weight chills) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Diarrhea), SOMNOLENCE (Sleepy), INCREASED APPETITE (Hungry), HANGOVER (Live hangover), CHILLS (Light weight chills) and NAUSEA (Nausea) outcome was unknown and IRRITABILITY (He was irritable) had resolved.            Concomitant product use was not provided.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-160354 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21 May 2021 contains details on: Events( weight chills and diarrhea were added as events). He received 2nd shot on 08 Apr 2021.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Achiness; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achiness) and PAIN IN EXTREMITY (Arm soreness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-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 12-Mar-2021, the patient experienced MYALGIA (Achiness) and PAIN IN EXTREMITY (Arm soreness). At the time of the report, MYALGIA (Achiness) and PAIN IN EXTREMITY (Arm soreness) outcome was unknown.            Concomitant product use was not provided by the reporter.   ? Patient wanted to know if it was okay to take Aspirin ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Rash
Clinical narrative: Itching; Rash which is increasing in size; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), RASH (Rash which is increasing in size) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (Fatigue). On 11-Mar-2021, the patient experienced PRURITUS (Itching) and RASH (Rash which is increasing in size). At the time of the report, PRURITUS (Itching) and RASH (Rash which is increasing in size) outcome was unknown and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list include synthetic thyroid medication. Treatment information was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever 101 F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever 101 F) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever 101 F). On 14-Mar-2021, CHILLS (Chills) and PYREXIA (Fever 101 F) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was reported.   No treatment information was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: excessive diarrhea; tender to touch; Hard like knot; swelling at the injection site; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (excessive diarrhea), VACCINATION SITE WARMTH (tender to touch), VACCINATION SITE MASS (Hard like knot), VACCINATION SITE SWELLING (swelling at the injection site) and CHILLS (severe chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and TIOTROPIUM BROMIDE (SPIRIVA RESPIMAT) for Asthma.    On 11-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 DIARRHOEA (excessive diarrhea), VACCINATION SITE WARMTH (tender to touch), VACCINATION SITE MASS (Hard like knot), VACCINATION SITE SWELLING (swelling at the injection site) and CHILLS (severe chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of UNK dosage form. On 13-Mar-2021, DIARRHOEA (excessive diarrhea), VACCINATION SITE WARMTH (tender to touch), VACCINATION SITE MASS (Hard like knot), VACCINATION SITE SWELLING (swelling at the injection site) and CHILLS (severe chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash on her right leg below the knee; hives on her right leg below the knee; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her right leg below the knee) and URTICARIA (hives on her right leg below the knee) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OV1B21A) 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 11-Mar-2021, the patient experienced RASH (rash on her right leg below the knee) and URTICARIA (hives on her right leg below the knee). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH (rash on her right leg below the knee) and URTICARIA (hives on her right leg below the knee) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Diarrhoea, Fatigue
Clinical narrative: Lost sense of taste and smell; Lost sense of taste and smell; Diarrhea; Coughing; Coughing; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Lost sense of taste and smell), AGEUSIA (Lost sense of taste and smell), DIARRHOEA (Diarrhea), COUGH (Coughing) and PYREXIA (Coughing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 DIARRHOEA (Diarrhea), COUGH (Coughing), PYREXIA (Coughing) and FATIGUE (Fatigue). On 14-Mar-2021, the patient experienced ANOSMIA (Lost sense of taste and smell) and AGEUSIA (Lost sense of taste and smell). At the time of the report, ANOSMIA (Lost sense of taste and smell), AGEUSIA (Lost sense of taste and smell), DIARRHOEA (Diarrhea), COUGH (Coughing), PYREXIA (Coughing) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment drugs included no concomitant drugs included   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Significant Followup Appended