chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site rash
Clinical narrative: rash 3 inches long, 2 inches wide and blotchy; small rash on the patient arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (rash 3 inches long, 2 inches wide and blotchy) and VACCINATION SITE RASH (small rash on the patient arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (small rash on the patient arm). On 17-Mar-2021, the patient experienced RASH MACULAR (rash 3 inches long, 2 inches wide and blotchy). In March 2021, VACCINATION SITE RASH (small rash on the patient arm) had resolved. At the time of the report, RASH MACULAR (rash 3 inches long, 2 inches wide and blotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  The patient was prescribed with an unspecified steroid and antibiotic cream.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of Right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of Right arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer. Concomitant products included ATORVASTATIN, LISINOPRIL and VITAMIN D NOS for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of Right arm). At the time of the report, PAIN IN EXTREMITY (Soreness of Right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication also included an unspecified breast cancer medication.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: TCR attached: Reporter's mailing address updated
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Erythema, Pruritus, Rash pruritic, Rash vesicular
Clinical narrative: rash on forehead - blisters, itchy, there is swelling and it's red; rash on forehead - blisters, itchy, there is swelling and it's red; rash on forehead - blisters, itchy, there is swelling and it's red; rash on forehead - blisters, itchy, there is swelling and it's red; scalp is itchy; This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (rash on forehead - blisters, itchy, there is swelling and it's red), SWELLING (rash on forehead - blisters, itchy, there is swelling and it's red), ERYTHEMA (rash on forehead - blisters, itchy, there is swelling and it's red), RASH VESICULAR (rash on forehead - blisters, itchy, there is swelling and it's red) and PRURITUS (scalp is itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-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) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced RASH PRURITIC (rash on forehead - blisters, itchy, there is swelling and it's red), SWELLING (rash on forehead - blisters, itchy, there is swelling and it's red), ERYTHEMA (rash on forehead - blisters, itchy, there is swelling and it's red), RASH VESICULAR (rash on forehead - blisters, itchy, there is swelling and it's red) and PRURITUS (scalp is itchy). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Adverse event, at a dose of UNK dosage form. In March 2021, RASH PRURITIC (rash on forehead - blisters, itchy, there is swelling and it's red), SWELLING (rash on forehead - blisters, itchy, there is swelling and it's red), ERYTHEMA (rash on forehead - blisters, itchy, there is swelling and it's red), RASH VESICULAR (rash on forehead - blisters, itchy, there is swelling and it's red) and PRURITUS (scalp is itchy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Biopsy: normal (normal) Biopsy over right eye, does not have cancer.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated event outcome and suspect product details.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: rash on forehead - blisters, itchy, there is swelling and it's red; rash on forehead - blisters, itchy, there is swelling and it's red; rash on forehead - blisters, itchy, there is swelling and it's red; rash on forehead - blisters, itchy, there is swelling and it's red; scalp is itchy; This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (rash on forehead - blisters, itchy, there is swelling and it's red), SWELLING (rash on forehead - blisters, itchy, there is swelling and it's red), ERYTHEMA (rash on forehead - blisters, itchy, there is swelling and it's red), RASH VESICULAR (rash on forehead - blisters, itchy, there is swelling and it's red) and PRURITUS (scalp is itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-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) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced RASH PRURITIC (rash on forehead - blisters, itchy, there is swelling and it's red), SWELLING (rash on forehead - blisters, itchy, there is swelling and it's red), ERYTHEMA (rash on forehead - blisters, itchy, there is swelling and it's red), RASH VESICULAR (rash on forehead - blisters, itchy, there is swelling and it's red) and PRURITUS (scalp is itchy). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Adverse event, at a dose of UNK dosage form. In March 2021, RASH PRURITIC (rash on forehead - blisters, itchy, there is swelling and it's red), SWELLING (rash on forehead - blisters, itchy, there is swelling and it's red), ERYTHEMA (rash on forehead - blisters, itchy, there is swelling and it's red), RASH VESICULAR (rash on forehead - blisters, itchy, there is swelling and it's red) and PRURITUS (scalp is itchy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Biopsy: normal (normal) Biopsy over right eye, does not have cancer.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Updated event outcome and suspect product details.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 3 in. diameter rash, perfectly round; This spontaneous case was reported by a consumer and describes the occurrence of RASH (3 in. diameter rash, perfectly round) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.    On 03-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 RASH (3 in. diameter rash, perfectly round). At the time of the report, RASH (3 in. diameter rash, perfectly round) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Sore throat; Sporadic headache lasting 4 hours; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Sporadic headache lasting 4 hours) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     The patient's past medical history included Cancer (Of vocal chords since 4-5 years).    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Sporadic headache lasting 4 hours). On 16-Mar-2021, HEADACHE (Sporadic headache lasting 4 hours) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Rash macular, Vaccination site pruritus
Clinical narrative: Moderna Covid vaccine arm (red round blotchy and itchy at the site of injection); itchy at the site of injection; a shooting pain (very quick) in collar bone on the left side; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (a shooting pain (very quick) in collar bone on the left side), RASH MACULAR (Moderna Covid vaccine arm (red round blotchy and itchy at the site of injection)) and VACCINATION SITE PRURITUS (itchy at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, ROSUVASTATIN, AMLODIPINE and ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced BONE PAIN (a shooting pain (very quick) in collar bone on the left side). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at the site of injection). On 17-Mar-2021, the patient experienced RASH MACULAR (Moderna Covid vaccine arm (red round blotchy and itchy at the site of injection)). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Vaccination site reaction, at a dose of UNK, qd. At the time of the report, BONE PAIN (a shooting pain (very quick) in collar bone on the left side), RASH MACULAR (Moderna Covid vaccine arm (red round blotchy and itchy at the site of injection)) and VACCINATION SITE PRURITUS (itchy at the site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Pain
Clinical narrative: dizziness /lightheadedness; body aches; chills; nausea; body aches; dizziness /light headedness; chills; nausea; This spontaneous case was reported by a patient and describes the occurrence of the second episode of PAIN (body aches), the first episode of PAIN (body aches), DIZZINESS (dizziness /lightheadedness), DIZZINESS (dizziness /light headedness) and the first episode of CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter .  Concomitant products included GABAPENTIN, CARISOPRODOL, LAMOTRIGINE, CLONAZEPAM, TRAMADOL, ESCITALOPRAM, ROSUVASTATIN, VITAMINS NOS and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced the first episode of PAIN (body aches), DIZZINESS (dizziness /light headedness), the first episode of CHILLS (chills) and the first episode of NAUSEA (nausea). On 16-Mar-2021, the patient experienced the second episode of PAIN (body aches), DIZZINESS (dizziness /lightheadedness), the second episode of CHILLS (chills) and the second episode of NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Mar-2021, DIZZINESS (dizziness /light headedness) had resolved. At the time of the report, last episode of PAIN (body aches), DIZZINESS (dizziness /lightheadedness), the last episode of CHILLS (chills) and the last episode of NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had the symptoms at the same night of vaccine administration which lasted for 2 days. The same symptoms came back again on 16-MAR-2021.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in the arm of the injection) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness in the arm of the injection). At the time of the report, VACCINATION SITE PAIN (Soreness in the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: Itchy arm; Swollen arm; Red at site of injection; Pain and soreness in calf muscle like charlie horse; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Pain and soreness in calf muscle like charlie horse), PRURITUS (Itchy arm), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red at site of injection) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain and soreness in calf muscle like charlie horse). On 18-Mar-2021, the patient experienced PRURITUS (Itchy arm), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red at site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in March 2021 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain and soreness in calf muscle like charlie horse), PRURITUS (Itchy arm), PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red at site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified birth control pills.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: sore arm/top of arm hurt; pain all in the muscle area; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm/top of arm hurt) and MYALGIA (pain all in the muscle area) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/top of arm hurt) and MYALGIA (pain all in the muscle area). At the time of the report, PAIN IN EXTREMITY (sore arm/top of arm hurt) and MYALGIA (pain all in the muscle area) had resolved. Not Provided          No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up Received: Patient denied having fax or email. AE's resolved.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: experienced fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (experienced fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M2019) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced FATIGUE (experienced fatigue). On 22-Feb-2021, FATIGUE (experienced fatigue) had resolved.            Concomitant information use was not reported.  Treatment information was not provided.    This case was linked to MOD-2021-014896 (E2B Linked Report).; Sender's Comments:  MOD-2021-014896:1st dose
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram, Feeling abnormal
Clinical narrative: felt terrible /felt horrible/felt bad; weak; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt terrible /felt horrible/felt bad) and ASTHENIA (weak) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (felt terrible /felt horrible/felt bad) and ASTHENIA (weak). At the time of the report, FEELING ABNORMAL (felt terrible /felt horrible/felt bad) and ASTHENIA (weak) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Computerised tomogram: inconclusive (Inconclusive) inconclusive.         Action taken with mRNA-1273 in response to the events was not applicable.  Patient was on Blood pressure medication and Blood thinner x2 for irregular heart beat. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD21-057566, MOD-2021-049422 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Back pain, Chest pain, Erythema
Clinical narrative: Lost of taste; Lost of smell; Pain in chest, back, middle to right side; Pain in chest, back, middle to right side; Tingling in my jaws, whole mouth, something was happening there; Redness in leg; Heaviness in my head; Buzzing in my ear; Non-sense irritation on site of injection; Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room; Tired all the time, sleep 3 hrs a day; Nausea, took tums and did magic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side) and PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer and Reflux gastritis. Concomitant products included LETROZOLE for Antiestrogen therapy, OMEPRAZOLE (MEDOPRAZOLE) for Reflux esophagitis, LEVOTHYROXINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side), PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there), ERYTHEMA (Redness in leg), HEAD DISCOMFORT (Heaviness in my head), TINNITUS (Buzzing in my ear), SKIN IRRITATION (Non-sense irritation on site of injection), FEELING ABNORMAL (Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room), FATIGUE (Tired all the time, sleep 3 hrs a day) and NAUSEA (Nausea, took tums and did magic). At the time of the report, AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side), PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there), ERYTHEMA (Redness in leg), HEAD DISCOMFORT (Heaviness in my head), TINNITUS (Buzzing in my ear), SKIN IRRITATION (Non-sense irritation on site of injection), FEELING ABNORMAL (Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room), FATIGUE (Tired all the time, sleep 3 hrs a day) and NAUSEA (Nausea, took tums and did magic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications was not provided by the reporter   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Head discomfort, Nausea, Paraesthesia oral
Clinical narrative: Lost of taste; Lost of smell; Pain in chest, back, middle to right side; Pain in chest, back, middle to right side; Tingling in my jaws, whole mouth, something was happening there; Redness in leg; Heaviness in my head; Buzzing in my ear; Non-sense irritation on site of injection; Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room; Tired all the time, sleep 3 hrs a day; Nausea, took tums and did magic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side) and PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer and Reflux gastritis. Concomitant products included LETROZOLE for Antiestrogen therapy, OMEPRAZOLE (MEDOPRAZOLE) for Reflux esophagitis, LEVOTHYROXINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side), PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there), ERYTHEMA (Redness in leg), HEAD DISCOMFORT (Heaviness in my head), TINNITUS (Buzzing in my ear), SKIN IRRITATION (Non-sense irritation on site of injection), FEELING ABNORMAL (Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room), FATIGUE (Tired all the time, sleep 3 hrs a day) and NAUSEA (Nausea, took tums and did magic). At the time of the report, AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side), PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there), ERYTHEMA (Redness in leg), HEAD DISCOMFORT (Heaviness in my head), TINNITUS (Buzzing in my ear), SKIN IRRITATION (Non-sense irritation on site of injection), FEELING ABNORMAL (Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room), FATIGUE (Tired all the time, sleep 3 hrs a day) and NAUSEA (Nausea, took tums and did magic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications was not provided by the reporter   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Skin irritation, Tinnitus
Clinical narrative: Lost of taste; Lost of smell; Pain in chest, back, middle to right side; Pain in chest, back, middle to right side; Tingling in my jaws, whole mouth, something was happening there; Redness in leg; Heaviness in my head; Buzzing in my ear; Non-sense irritation on site of injection; Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room; Tired all the time, sleep 3 hrs a day; Nausea, took tums and did magic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side) and PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer and Reflux gastritis. Concomitant products included LETROZOLE for Antiestrogen therapy, OMEPRAZOLE (MEDOPRAZOLE) for Reflux esophagitis, LEVOTHYROXINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side), PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there), ERYTHEMA (Redness in leg), HEAD DISCOMFORT (Heaviness in my head), TINNITUS (Buzzing in my ear), SKIN IRRITATION (Non-sense irritation on site of injection), FEELING ABNORMAL (Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room), FATIGUE (Tired all the time, sleep 3 hrs a day) and NAUSEA (Nausea, took tums and did magic). At the time of the report, AGEUSIA (Lost of taste), ANOSMIA (Lost of smell), CHEST PAIN (Pain in chest, back, middle to right side), BACK PAIN (Pain in chest, back, middle to right side), PARAESTHESIA ORAL (Tingling in my jaws, whole mouth, something was happening there), ERYTHEMA (Redness in leg), HEAD DISCOMFORT (Heaviness in my head), TINNITUS (Buzzing in my ear), SKIN IRRITATION (Non-sense irritation on site of injection), FEELING ABNORMAL (Awful and was similar to being positive with covid-19, Covid brain, Could not take myself to emergency room), FATIGUE (Tired all the time, sleep 3 hrs a day) and NAUSEA (Nausea, took tums and did magic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications was not provided by the reporter   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Feeling hot, Hyperhidrosis, Pyrexia
Clinical narrative: extremly hot; extremely swollen; quarter sized blisters; covid arm; sweats; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (extremly hot), SWELLING (extremely swollen), BLISTER (quarter sized blisters), VACCINATION SITE REACTION (covid arm) and HYPERHIDROSIS (sweats) in a 71-year-old female patient 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 an unknown date, the patient experienced FEELING HOT (extremly hot), SWELLING (extremely swollen), BLISTER (quarter sized blisters), VACCINATION SITE REACTION (covid arm), HYPERHIDROSIS (sweats), CHILLS (chills) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN at a dose of 2 dosage form. At the time of the report, FEELING HOT (extremly hot), SWELLING (extremely swollen), BLISTER (quarter sized blisters), VACCINATION SITE REACTION (covid arm), HYPERHIDROSIS (sweats), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site reaction
Clinical narrative: extremly hot; extremely swollen; quarter sized blisters; covid arm; sweats; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (extremly hot), SWELLING (extremely swollen), BLISTER (quarter sized blisters), VACCINATION SITE REACTION (covid arm) and HYPERHIDROSIS (sweats) in a 71-year-old female patient 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 an unknown date, the patient experienced FEELING HOT (extremly hot), SWELLING (extremely swollen), BLISTER (quarter sized blisters), VACCINATION SITE REACTION (covid arm), HYPERHIDROSIS (sweats), CHILLS (chills) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN at a dose of 2 dosage form. At the time of the report, FEELING HOT (extremly hot), SWELLING (extremely swollen), BLISTER (quarter sized blisters), VACCINATION SITE REACTION (covid arm), HYPERHIDROSIS (sweats), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Delayed throbbing, radiating pain in arm after 2nd dose; Initial soreness in arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Initial soreness in arm after 2nd dose) and PAIN (Delayed throbbing, radiating pain in arm after 2nd dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029l20a and 003a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-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 PAIN IN EXTREMITY (Initial soreness in arm after 2nd dose). On an unknown date, the patient experienced PAIN (Delayed throbbing, radiating pain in arm after 2nd dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and TYLENOL at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Initial soreness in arm after 2nd dose) and PAIN (Delayed throbbing, radiating pain in arm after 2nd dose) outcome was unknown. Not Provided          Patient tried pain relieving creams No  Concomitant medications were provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Malaise, Pain in extremity
Clinical narrative: arm was so sore she could not lift it; fatigue; stomach issues; general unwell feeling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was so sore she could not lift it), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (stomach issues) and MALAISE (general unwell feeling) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (arm was so sore she could not lift it), FATIGUE (fatigue), ABDOMINAL DISCOMFORT (stomach issues) and MALAISE (general unwell feeling). In March 2021, PAIN IN EXTREMITY (arm was so sore she could not lift it) outcome was unknown. At the time of the report, FATIGUE (fatigue), ABDOMINAL DISCOMFORT (stomach issues) and MALAISE (general unwell feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Tachycardia
Clinical narrative: fast heart rate; dizziness; weakness; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (fast heart rate), DIZZINESS (dizziness), ASTHENIA (weakness) and DYSPNOEA (difficulty breathing) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, METFORMIN and LISINOPRIL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced TACHYCARDIA (fast heart rate), DIZZINESS (dizziness), ASTHENIA (weakness) and DYSPNOEA (difficulty breathing). At the time of the report, TACHYCARDIA (fast heart rate), DIZZINESS (dizziness), ASTHENIA (weakness) and DYSPNOEA (difficulty breathing) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching in different part of the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in different part of the body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic and Drug allergy. Concomitant products included FAMOTIDINE for Acid reflux (esophageal), MONTELUKAST for Allergy, SIMVASTATIN for Cholesterol high, SERTRALINE and BUSPIRONE for Panic disorder.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021 at 11:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Itching in different part of the body). On 19-Mar-2021 at 1:00 PM, PRURITUS (Itching in different part of the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14 Jul 2021 contains : Patient Details Updated, Event Stop date & Duration Updated
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 89-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 03-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) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. Not Provided          No concomitant medication was reported.  No treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: sweaty; heart was pounding really hard; dizzy; arm sore; body aches; fever; headaches; joint aches; very tired; hot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), PALPITATIONS (heart was pounding really hard), DIZZINESS (dizzy), MYALGIA (arm sore) and MYALGIA (body aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Alcohol addiction (Patient states he is a beer drinker). Concomitant products included LORAZEPAM for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 HYPERHIDROSIS (sweaty), PALPITATIONS (heart was pounding really hard), DIZZINESS (dizzy), MYALGIA (arm sore), MYALGIA (body aches), PYREXIA (fever), HEADACHE (headaches), ARTHRALGIA (joint aches), FATIGUE (very tired) and PYREXIA (hot). At the time of the report, HYPERHIDROSIS (sweaty), PALPITATIONS (heart was pounding really hard), DIZZINESS (dizzy), MYALGIA (arm sore), MYALGIA (body aches), PYREXIA (fever), HEADACHE (headaches), ARTHRALGIA (joint aches), FATIGUE (very tired) and PYREXIA (hot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Patient reports taking Tylenol and Advil.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Palpitations, Pyrexia
Clinical narrative: sweaty; heart was pounding really hard; dizzy; arm sore; body aches; fever; headaches; joint aches; very tired; hot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), PALPITATIONS (heart was pounding really hard), DIZZINESS (dizzy), MYALGIA (arm sore) and MYALGIA (body aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Alcohol addiction (Patient states he is a beer drinker). Concomitant products included LORAZEPAM for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 HYPERHIDROSIS (sweaty), PALPITATIONS (heart was pounding really hard), DIZZINESS (dizzy), MYALGIA (arm sore), MYALGIA (body aches), PYREXIA (fever), HEADACHE (headaches), ARTHRALGIA (joint aches), FATIGUE (very tired) and PYREXIA (hot). At the time of the report, HYPERHIDROSIS (sweaty), PALPITATIONS (heart was pounding really hard), DIZZINESS (dizzy), MYALGIA (arm sore), MYALGIA (body aches), PYREXIA (fever), HEADACHE (headaches), ARTHRALGIA (joint aches), FATIGUE (very tired) and PYREXIA (hot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable. Patient reports taking Tylenol and Advil.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Peripheral swelling, Ultrasound scan
Clinical narrative: Leg swelling, "It's different this time"; Sensitivity dorsally from knee to calf; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Leg swelling, "It's different this time") and HYPERAESTHESIA (Sensitivity dorsally from knee to calf) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included DVT (groin to ankle left leg), Benign essential tremor and Factor II deficiency. Concurrent medical conditions included Shellfish allergy, Sulfonamide allergy, Iodine allergy, Gluten sensitivity, Dairy intolerance and Drug allergy. Concomitant products included APIXABAN (ELIQUIS), PROPRANOLOL, LEVOTHYROXINE SODIUM (SYNTHROID), NORTRIPTYLINE, RABEPRAZOLE SODIUM (ACIPHEX), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FUROSEMIDE and BETAMETHASONE for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Leg swelling, "It's different this time") and HYPERAESTHESIA (Sensitivity dorsally from knee to calf). At the time of the report, PERIPHERAL SWELLING (Leg swelling, "It's different this time") and HYPERAESTHESIA (Sensitivity dorsally from knee to calf) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: (Negative) Negative.         The concomitant medication included singular used for an unknown indication.  The treatment medications were not provided.  The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-049437 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Nausea, Paraesthesia
Clinical narrative: Pins and needles sensations all over the body; Lack of sleep due to symptoms; Pain on joints and muscle all over the body; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles sensations all over the body), INSOMNIA (Lack of sleep due to symptoms), ARTHRALGIA (Pain on joints and muscle all over the body) and NAUSEA (Nausea) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included SALBUTAMOL (ALBUTEROL HFA), IPRATROPIUM and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 11-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 PARAESTHESIA (Pins and needles sensations all over the body), INSOMNIA (Lack of sleep due to symptoms), ARTHRALGIA (Pain on joints and muscle all over the body) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Pins and needles sensations all over the body), INSOMNIA (Lack of sleep due to symptoms), ARTHRALGIA (Pain on joints and muscle all over the body) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: hurt and itch a bit; red patch; aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (hurt and itch a bit), ERYTHEMA (red patch) and PAIN IN EXTREMITY (aches and pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (hurt and itch a bit), ERYTHEMA (red patch) and PAIN IN EXTREMITY (aches and pain). At the time of the report, PRURITUS (hurt and itch a bit), ERYTHEMA (red patch) and PAIN IN EXTREMITY (aches and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypogeusia
Clinical narrative: Decreased loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGEUSIA (Decreased loss of taste) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) 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 17-Mar-2021, the patient experienced HYPOGEUSIA (Decreased loss of taste). At the time of the report, HYPOGEUSIA (Decreased loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not mentioned.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given to 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was given to 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was given to 17 year old). On 16-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was given to 17 year old) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.