chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 doses of Moderna COVID-19 vaccine left past 6 hours They kept it in the refrigerator. accidently they gave 2 doses to two patients; A spontaneous report from was received from a healthcare Professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the Potential expired doses administered to two patients .    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05-MAR-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 05-MAR-2021, It was reported that 10 doses of Moderna COVID-19 vaccine were left past 6 hours. They kept it in the refrigerator.The Potential expired doses were administered to two patients.   Laboratory details if provided.  Treatment details if provided or No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event is considered as resolved.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: The arm started itching and turning red and then it broken up all over, itches everything; The arm started itching and turning red and then it broken up all over, itches everything; Arm started itching and turning red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything), INJECTION SITE PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything) and INJECTION SITE ERYTHEMA (Arm started itching and turning red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything), INJECTION SITE PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything) and INJECTION SITE ERYTHEMA (Arm started itching and turning red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything), INJECTION SITE PRURITUS (The arm started itching and turning red and then it broken up all over, itches everything) and INJECTION SITE ERYTHEMA (Arm started itching and turning red) outcome was unknown.            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.  Concomitant product use was not provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: itchy left arm; little hives; swollen upper lip; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy left arm), URTICARIA (little hives) and LIP SWELLING (swollen upper lip) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Diabetes. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) and METFORMIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PRURITUS (itchy left arm), URTICARIA (little hives) and LIP SWELLING (swollen upper lip). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at a dose of 1 dosage form once a day. At the time of the report, PRURITUS (itchy left arm), URTICARIA (little hives) and LIP SWELLING (swollen upper lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included a statin and blood pressure medication.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well) in a female 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 MALAISE (Not feeling well). At the time of the report, MALAISE (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Nasal congestion, Nasopharyngitis
Clinical narrative: feels drained; he felt drugged; brain fog; Headache; congestion; Felt like he was catching a cold; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt like he was catching a cold), PAIN (Body aches), HEADACHE (Headache), NASAL CONGESTION (congestion) and FEELING ABNORMAL (brain fog) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 07-Mar-2021, the patient experienced NASOPHARYNGITIS (Felt like he was catching a cold) and PAIN (Body aches). On 08-Mar-2021, the patient experienced HEADACHE (Headache) and NASAL CONGESTION (congestion). On 09-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog). On an unknown date, the patient experienced FATIGUE (feels drained) and FEELING ABNORMAL (he felt drugged). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day and IBUPROFEN (ADVEL) at a dose of 1 dosage form once a day. On 08-Mar-2021, HEADACHE (Headache) and NASAL CONGESTION (congestion) had resolved. At the time of the report, NASOPHARYNGITIS (Felt like he was catching a cold), PAIN (Body aches) and FEELING ABNORMAL (brain fog) was resolving and FATIGUE (feels drained) and FEELING ABNORMAL (he felt drugged) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient received treatment information includes Tylenol and Advil(Ibuprofen) .   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: A follow up case was received on 15-MAR-2021. Patient demographic details were added.  Product information was added. Events are updated.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: feels drained; he felt drugged; brain fog; Headache; congestion; Felt like he was catching a cold; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt like he was catching a cold), PAIN (Body aches), HEADACHE (Headache), NASAL CONGESTION (congestion) and FEELING ABNORMAL (brain fog) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 07-Mar-2021, the patient experienced NASOPHARYNGITIS (Felt like he was catching a cold) and PAIN (Body aches). On 08-Mar-2021, the patient experienced HEADACHE (Headache) and NASAL CONGESTION (congestion). On 09-Mar-2021, the patient experienced FEELING ABNORMAL (brain fog). On an unknown date, the patient experienced FATIGUE (feels drained) and FEELING ABNORMAL (he felt drugged). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day and IBUPROFEN (ADVEL) at a dose of 1 dosage form once a day. On 08-Mar-2021, HEADACHE (Headache) and NASAL CONGESTION (congestion) had resolved. At the time of the report, NASOPHARYNGITIS (Felt like he was catching a cold), PAIN (Body aches) and FEELING ABNORMAL (brain fog) was resolving and FATIGUE (feels drained) and FEELING ABNORMAL (he felt drugged) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient received treatment information includes Tylenol and Advil(Ibuprofen) .   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: A follow up case was received on 15-MAR-2021. Patient demographic details were added.  Product information was added. Events are updated.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disorientation, Dizziness, Fatigue, Headache
Clinical narrative: Fatigue; Chills; Muscle Pain; Headaches; Dizzy; Itchy; Mentally Disoriented; Big red ball at injection site,swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Big red ball at injection site,swelling at injection site), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle Pain) and HEADACHE (Headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Big red ball at injection site,swelling at injection site), CHILLS (Chills), MYALGIA (Muscle Pain), HEADACHE (Headaches), DIZZINESS (Dizzy), PRURITUS (Itchy) and DISORIENTATION (Mentally Disoriented). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day. At the time of the report, VACCINATION SITE SWELLING (Big red ball at injection site,swelling at injection site), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle Pain), HEADACHE (Headaches), DIZZINESS (Dizzy), PRURITUS (Itchy) and DISORIENTATION (Mentally Disoriented) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included for asthma , allergies medications.    This case was linked to MOD-2021-067314 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Vaccination site swelling
Clinical narrative: Fatigue; Chills; Muscle Pain; Headaches; Dizzy; Itchy; Mentally Disoriented; Big red ball at injection site,swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Big red ball at injection site,swelling at injection site), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle Pain) and HEADACHE (Headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Big red ball at injection site,swelling at injection site), CHILLS (Chills), MYALGIA (Muscle Pain), HEADACHE (Headaches), DIZZINESS (Dizzy), PRURITUS (Itchy) and DISORIENTATION (Mentally Disoriented). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day. At the time of the report, VACCINATION SITE SWELLING (Big red ball at injection site,swelling at injection site), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (Muscle Pain), HEADACHE (Headaches), DIZZINESS (Dizzy), PRURITUS (Itchy) and DISORIENTATION (Mentally Disoriented) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included for asthma , allergies medications.    This case was linked to MOD-2021-067314 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Urticaria
Clinical narrative: Pain in my left arm; It is like a welt; Very large red rash on my muscle on my left arm; About 5 in. x 4 in. across my bicep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in my left arm), URTICARIA (It is like a welt), RASH (Very large red rash on my muscle on my left arm) and RASH (About 5 in. x 4 in. across my bicep) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (In the left arm.). Concurrent medical conditions included Heart disease, unspecified (taking heart medication.) and Arthritis (In Left shoulder.).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in my left arm), URTICARIA (It is like a welt), RASH (Very large red rash on my muscle on my left arm) and RASH (About 5 in. x 4 in. across my bicep). At the time of the report, PAIN IN EXTREMITY (Pain in my left arm), URTICARIA (It is like a welt), RASH (Very large red rash on my muscle on my left arm) and RASH (About 5 in. x 4 in. across my bicep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: feeling pain at injection site; injection site is turned into black and blue in color; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (feeling pain at injection site) and VACCINATION SITE DISCOLOURATION (injection site is turned into black and blue in color) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (feeling pain at injection site) and VACCINATION SITE DISCOLOURATION (injection site is turned into black and blue in color). At the time of the report, VACCINATION SITE PAIN (feeling pain at injection site) and VACCINATION SITE DISCOLOURATION (injection site is turned into black and blue in color) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine administration to a 16 year old; A spontaneous report was received from a nurse concerning a 16-year-old, female who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 19 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19 Feb 2021, it was reported that the Moderna COVID-19 vaccine was administered to 16-year-old. No adverse events were reported.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   On 19 Feb 2021, the outcome of the event, product administered to patient of inappropriate age, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 007M20A) with no associated AEs reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Tachycardia, Vaccination site pain, Vaccination site warmth
Clinical narrative: Tachycardia; Fever reaching 102 degrees Fahrenheit; Injection site was sore; Injection site warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), VACCINATION SITE WARMTH (Injection site warm to touch), PYREXIA (Fever reaching 102 degrees Fahrenheit) and VACCINATION SITE PAIN (Injection site was sore) in a 60-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 Kidney failure, COVID-19 and Dialysis.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch) and VACCINATION SITE PAIN (Injection site was sore). On 25-Feb-2021, the patient experienced PYREXIA (Fever reaching 102 degrees Fahrenheit). On 26-Feb-2021, the patient experienced TACHYCARDIA (Tachycardia). On 25-Feb-2021, PYREXIA (Fever reaching 102 degrees Fahrenheit) had resolved. On 28-Feb-2021, VACCINATION SITE WARMTH (Injection site warm to touch) and VACCINATION SITE PAIN (Injection site was sore) had resolved. On 05-Mar-2021, TACHYCARDIA (Tachycardia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees fahrenheit (Inconclusive) 102 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  2 CAT scans performed (result not reported). No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Product dose omission issue
Clinical narrative: the patient had to wait 90 days before he could receive his 2nd dose of Moderna vaccine; he tested positive for covid after being exposed to someone who was positive for covid; diagnosed with COVID-19 7 days after First dose of vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (diagnosed with COVID-19 7 days after First dose of vaccine), PRODUCT DOSE OMISSION ISSUE (the patient had to wait 90 days before he could receive his 2nd dose of Moderna vaccine) and EXPOSURE TO SARS-COV-2 (he tested positive for covid after being exposed to someone who was positive for covid) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 003C21A) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy (the colonoscopy is a 5-year routine exam and had it 3 times in the past per the patient prior to Moderna vaccine). Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN, ATORVASTATIN, METOPROLOL and CLOPIDOGREL for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced COVID-19 (diagnosed with COVID-19 7 days after First dose of vaccine) and EXPOSURE TO SARS-COV-2 (he tested positive for covid after being exposed to someone who was positive for covid). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (the patient had to wait 90 days before he could receive his 2nd dose of Moderna vaccine). At the time of the report, COVID-19 (diagnosed with COVID-19 7 days after First dose of vaccine) and EXPOSURE TO SARS-COV-2 (he tested positive for covid after being exposed to someone who was positive for covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (the patient had to wait 90 days before he could receive his 2nd dose of Moderna vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient reported that he went on to take regeneron monoclonal antibodies due to his age. He has beentold by his physician that he can not take the COVID-19 vaccine within 90 days of his regeneron medication.  No laboratory details was given. No treatment information was given.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up was received on 10-MAY-2021 which contained the contact information and second dose details of the suspect product were added.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose decreased, Blood glucose fluctuation, Blood pressure decreased, Blood pressure measurement
Clinical narrative: sore arm; tired; throat started burning; weak; sores around mouth; chills; sugar dropped; blood pressure dropped; body aches; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills) and BLOOD GLUCOSE DECREASED (sugar dropped) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills), BLOOD GLUCOSE DECREASED (sugar dropped), BLOOD PRESSURE DECREASED (blood pressure dropped) and MYALGIA (body aches). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). At the time of the report, THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills), BLOOD GLUCOSE DECREASED (sugar dropped), BLOOD PRESSURE DECREASED (blood pressure dropped), MYALGIA (body aches) and PAIN IN EXTREMITY (sore arm) had resolved and FATIGUE (tired) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Blood glucose fluctuation: 24-feb-2021 abnormal Low. On 24-Feb-2021, Blood pressure measurement: lower abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Consumer declined to provide contact information. No other information was provided
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Stomatitis
Clinical narrative: sore arm; tired; throat started burning; weak; sores around mouth; chills; sugar dropped; blood pressure dropped; body aches; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills) and BLOOD GLUCOSE DECREASED (sugar dropped) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills), BLOOD GLUCOSE DECREASED (sugar dropped), BLOOD PRESSURE DECREASED (blood pressure dropped) and MYALGIA (body aches). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). At the time of the report, THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills), BLOOD GLUCOSE DECREASED (sugar dropped), BLOOD PRESSURE DECREASED (blood pressure dropped), MYALGIA (body aches) and PAIN IN EXTREMITY (sore arm) had resolved and FATIGUE (tired) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Blood glucose fluctuation: 24-feb-2021 abnormal Low. On 24-Feb-2021, Blood pressure measurement: lower abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Consumer declined to provide contact information. No other information was provided
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: sore arm; tired; throat started burning; weak; sores around mouth; chills; sugar dropped; blood pressure dropped; body aches; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills) and BLOOD GLUCOSE DECREASED (sugar dropped) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills), BLOOD GLUCOSE DECREASED (sugar dropped), BLOOD PRESSURE DECREASED (blood pressure dropped) and MYALGIA (body aches). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). At the time of the report, THROAT IRRITATION (throat started burning), ASTHENIA (weak), STOMATITIS (sores around mouth), CHILLS (chills), BLOOD GLUCOSE DECREASED (sugar dropped), BLOOD PRESSURE DECREASED (blood pressure dropped), MYALGIA (body aches) and PAIN IN EXTREMITY (sore arm) had resolved and FATIGUE (tired) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, Blood glucose fluctuation: 24-feb-2021 abnormal Low. On 24-Feb-2021, Blood pressure measurement: lower abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes blood pressure medication.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Consumer declined to provide contact information. No other information was provided
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Influenza like illness, Insomnia
Clinical narrative: fever; insomia; Joint pain; muscle aches; flu like symptoms; Chills; nausea; he was aching; losing appetite; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), INSOMNIA (insomia), ARTHRALGIA (Joint pain), MYALGIA (muscle aches) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (fever), INSOMNIA (insomia), ARTHRALGIA (Joint pain), MYALGIA (muscle aches), INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (Chills), NAUSEA (nausea), PAIN (he was aching) and DECREASED APPETITE (losing appetite). On 07-Mar-2021, PYREXIA (fever), INSOMNIA (insomia), ARTHRALGIA (Joint pain), MYALGIA (muscle aches), INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (Chills), NAUSEA (nausea), PAIN (he was aching) and DECREASED APPETITE (losing appetite) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: fever; insomia; Joint pain; muscle aches; flu like symptoms; Chills; nausea; he was aching; losing appetite; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), INSOMNIA (insomia), ARTHRALGIA (Joint pain), MYALGIA (muscle aches) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (fever), INSOMNIA (insomia), ARTHRALGIA (Joint pain), MYALGIA (muscle aches), INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (Chills), NAUSEA (nausea), PAIN (he was aching) and DECREASED APPETITE (losing appetite). On 07-Mar-2021, PYREXIA (fever), INSOMNIA (insomia), ARTHRALGIA (Joint pain), MYALGIA (muscle aches), INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (Chills), NAUSEA (nausea), PAIN (he was aching) and DECREASED APPETITE (losing appetite) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Migraine, Thinking abnormal
Clinical narrative: weakness; foggy thinking; migraine; exhaustion; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), THINKING ABNORMAL (foggy thinking), MIGRAINE (migraine) and FATIGUE (exhaustion) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced ASTHENIA (weakness), THINKING ABNORMAL (foggy thinking), MIGRAINE (migraine) and FATIGUE (exhaustion). At the time of the report, ASTHENIA (weakness), THINKING ABNORMAL (foggy thinking), MIGRAINE (migraine) and FATIGUE (exhaustion) 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.   Treatment information not provided. List of concomitant medication were not given.
Age: 64.0
Sex: F
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 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 PAIN IN EXTREMITY (Sore arm). On 05-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not taken by patient. Concomitant medication was not provided. Patient was scheduled her cataracts surgery on 17-Mar-2021, and would get second dose of the vaccine on 01-Apr-2021, then she had dental work on 06-Apr-2021.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Sleep disorder
Clinical narrative: weak legs; Extreme sleep-out of character; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weak legs), SLEEP DISORDER (Extreme sleep-out of character) and MYALGIA (sore arm) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weak legs), SLEEP DISORDER (Extreme sleep-out of character) and MYALGIA (sore arm). At the time of the report, MUSCULAR WEAKNESS (weak legs), SLEEP DISORDER (Extreme sleep-out of character) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure medications unknown , blood thinner unknown , eye drops unknown. Treatment History included icepack to arm for soreness.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Mailing Address was updated.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: Zero antibodies on antibody test for COVID antibodies; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Zero antibodies on antibody test for COVID antibodies) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Relapsing-remitting multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Zero antibodies on antibody test for COVID antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (Zero antibodies on antibody test for COVID antibodies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: inconclusive (Inconclusive) Zero antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication are not provided. Treatment information does not provided.   Reporter did not allow further contact
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site induration
Clinical narrative: injitching; hard arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (injitching) and VACCINATION SITE INDURATION (hard arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (injitching) and VACCINATION SITE INDURATION (hard arm). At the time of the report, PRURITUS (injitching) and VACCINATION SITE INDURATION (hard arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not provided. Treatment medications was not provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DIZZINESS (Dizziness) and HEART RATE INCREASED (Increased Heart Rate). On 07-Mar-2021, DIZZINESS (Dizziness) and HEART RATE INCREASED (Increased Heart Rate) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Gait disturbance, Hypertension, Pain in extremity, Peripheral swelling
Clinical narrative: blood pressure going high; Leg started swelling up; right leg is swollen and painful; could hardly walk / couldn't walk for weeks; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Leg started swelling up), PAIN IN EXTREMITY (right leg is swollen and painful), GAIT DISTURBANCE (could hardly walk / couldn't walk for weeks) and HYPERTENSION (blood pressure going high ) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 26-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) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PERIPHERAL SWELLING (Leg started swelling up), PAIN IN EXTREMITY (right leg is swollen and painful) and GAIT DISTURBANCE (could hardly walk / couldn't walk for weeks). On 27-Feb-2021, the patient experienced HYPERTENSION (blood pressure going high ). The patient was treated with DICLOFENAC SODIUM for Leg pain, at a dose of 1 UNK. At the time of the report, PERIPHERAL SWELLING (Leg started swelling up), PAIN IN EXTREMITY (right leg is swollen and painful), GAIT DISTURBANCE (could hardly walk / couldn't walk for weeks) and HYPERTENSION (blood pressure going high ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Blood pressure measurement: 202/94 (High) 202/94.         No Concomitant medications were reported.  Action taken with mRNA-1273 in response to the events were Not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Live FU added to Initial case where new events added and case upgraded to due addition of event blood pressure is really high. 202/94. This FU line was not ticked as significant because this leads to change in Regulatory Clock start date. On 21-Jun-2021: Follow up received on 21-06-2021 and treatment medication was updated
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: elevated WBCs; 103 fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (elevated WBCs) and PYREXIA (103 fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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 02-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 WHITE BLOOD CELL COUNT INCREASED (elevated WBCs) and PYREXIA (103 fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, WHITE BLOOD CELL COUNT INCREASED (elevated WBCs) and PYREXIA (103 fever) outcome was unknown.            Treatments for the events included Ibuprofen and paracetamol.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Myalgia
Clinical narrative: the legs turned to jelly, didn't had any strength in the legs; muscle pain; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) in a female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she had to call fire department and police department for the reported events.   Concomitant product use was not provided by the reporter.  Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) in a female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, LIMB DISCOMFORT (the legs turned to jelly, didn't had any strength in the legs), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated she had to call the fire department and police department for the reported events.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. Concomitant products included LEVOFLOXACIN (LOVENOX [LEVOFLOXACIN]), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and L-METHYLFOLATE for an unknown indication. On 05-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 18-Dec-2020 and the estimated date of delivery was 24-Sep-2021. On 05-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Rash
Clinical narrative: Felt sick; Delayed rash on chest and neck; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt sick) and RASH (Delayed rash on chest and neck) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included VALSARTAN, APIXABAN (ELIQUIS), LEVOTHYROXINE and DENOSUMAB (PROLIA) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced RASH (Delayed rash on chest and neck). On an unknown date, the patient experienced ILLNESS (Felt sick). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, ILLNESS (Felt sick) and RASH (Delayed rash on chest and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included antihistamine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow up information was received on 11 Jun 2021: added new event
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Lip oedema, Lip swelling, Oral discomfort
Clinical narrative: Swollen Lips; Fluffy Lips; Funny lips; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISCOMFORT (Funny lips), LIP SWELLING (Swollen Lips) and LIP OEDEMA (Fluffy Lips) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030821A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 ORAL DISCOMFORT (Funny lips). On 06-Mar-2021, the patient experienced LIP SWELLING (Swollen Lips) and LIP OEDEMA (Fluffy Lips). At the time of the report, ORAL DISCOMFORT (Funny lips), LIP SWELLING (Swollen Lips) and LIP OEDEMA (Fluffy Lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  treatment information was not provided.