chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Pruritus, Rash vesicular
Clinical narrative: itchy; Leg and hip pain; Rash with blisters; Leg and hip pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (Rash with blisters), PAIN IN EXTREMITY (Leg and hip pain), PRURITUS (itchy) and ARTHRALGIA (Leg and hip pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE SODIUM (METHOTREXATE INJECTION BP), ESCITALOPRAM OXALATE (LEXAPRO), SIMVASTATIN, MONTELUKAST SODIUM (SINGULAIR), VITAMIN C [ASCORBIC ACID], MAGNESIUM CITRATE, VITAMIN D3, FOLIC ACID and BIOTIN for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced RASH VESICULAR (Rash with blisters), PAIN IN EXTREMITY (Leg and hip pain) and ARTHRALGIA (Leg and hip pain). On an unknown date, the patient experienced PRURITUS (itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency and GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORINE) at an unspecified dose and frequency. At the time of the report, RASH VESICULAR (Rash with blisters), PAIN IN EXTREMITY (Leg and hip pain), PRURITUS (itchy) and ARTHRALGIA (Leg and hip pain) had not resolved.            The action taken with mRNA-1273 in response to the event was not applicable.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: slight fever; soreness in the muscle.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever) and MYALGIA (soreness in the muscle.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Paraplegic (He has broken back from 44 years ago and it's paraplegic.).    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PYREXIA (slight fever) and MYALGIA (soreness in the muscle.). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (slight fever) and MYALGIA (soreness in the muscle.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported. Treatment was reported as Tylenol.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise
Clinical narrative: not feeling well; swollen glands on the neck which was going on and off; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and LYMPHADENOPATHY (swollen glands on the neck which was going on and off) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well) and LYMPHADENOPATHY (swollen glands on the neck which was going on and off). At the time of the report, MALAISE (not feeling well) and LYMPHADENOPATHY (swollen glands on the neck which was going on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: Rib pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Rib pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Parkinson's disease.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Rib pain). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Rib pain) had resolved.            No treatment medication were provided. No concomitant medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: want to do the pregnancy registry thin; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (want to do the pregnancy registry thin) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (want to do the pregnancy registry thin). At the time of the report, EXPOSURE DURING PREGNANCY (want to do the pregnancy registry thin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: lump that feels like a knot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump that feels like a knot) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01SM201A) 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) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE MASS (lump that feels like a knot). At the time of the report, VACCINATION SITE MASS (lump that feels like a knot) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Patient started with really bad leg cramps early morning next day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Patient started with really bad leg cramps early morning next day after receiving 1st dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN and POTASSIUM for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Mar-2021, the patient experienced MUSCLE SPASMS (Patient started with really bad leg cramps early morning next day after receiving 1st dose). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. On 22-Mar-2021, MUSCLE SPASMS (Patient started with really bad leg cramps early morning next day after receiving 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines included Diabetic medications, Blood pressure medication, seizure medication, Cholesterol medication   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received and  Patient declined for further contact.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 73-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment provided include Regeneron (casirivimab and imdevimab) therapy.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mass, Nausea, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of upper left arm), MASS (Big, rock-hard wheal under the skin of upper left arm, described to be by the next day huge as big as a closed fist or open hand), FATIGUE (Tired) and NAUSEA (Nauseated) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to insect sting (Swelling/ histamine reactions to bee and wasp stings). Concomitant products included SIMVASTATIN, VITAMIN D NOS, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), LEVOTHYROXINE and BUPROPION 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 PERIPHERAL SWELLING (Swelling of upper left arm) and MASS (Big, rock-hard wheal under the skin of upper left arm, described to be by the next day huge as big as a closed fist or open hand). On 21-Mar-2021, the patient experienced NAUSEA (Nauseated). On an unknown date, the patient experienced FATIGUE (Tired). On 20-Mar-2021, PERIPHERAL SWELLING (Swelling of upper left arm) and MASS (Big, rock-hard wheal under the skin of upper left arm, described to be by the next day huge as big as a closed fist or open hand) had resolved. On 22-Mar-2021, NAUSEA (Nauseated) had resolved. At the time of the report, FATIGUE (Tired) 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.   No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Nasal congestion, Presyncope
Clinical narrative: vertigo; dizziness; nasal congestion; breaking into sweats; feeling like is going to pass out; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizziness), NASAL CONGESTION (nasal congestion), HYPERHIDROSIS (breaking into sweats) and PRESYNCOPE (feeling like is going to pass out) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A5-22) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VERTIGO (vertigo), DIZZINESS (dizziness), NASAL CONGESTION (nasal congestion), HYPERHIDROSIS (breaking into sweats), PRESYNCOPE (feeling like is going to pass out) and FATIGUE (fatigue). At the time of the report, VERTIGO (vertigo), DIZZINESS (dizziness), NASAL CONGESTION (nasal congestion), HYPERHIDROSIS (breaking into sweats), PRESYNCOPE (feeling like is going to pass out) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications included.  Treatment medications like Claritin (Loratadine) is used for vertigo.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; dizziness; nasal congestion; breaking into sweats; feeling like is going to pass out; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (dizziness), NASAL CONGESTION (nasal congestion), HYPERHIDROSIS (breaking into sweats) and PRESYNCOPE (feeling like is going to pass out) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A5-22) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VERTIGO (vertigo), DIZZINESS (dizziness), NASAL CONGESTION (nasal congestion), HYPERHIDROSIS (breaking into sweats), PRESYNCOPE (feeling like is going to pass out) and FATIGUE (fatigue). At the time of the report, VERTIGO (vertigo), DIZZINESS (dizziness), NASAL CONGESTION (nasal congestion), HYPERHIDROSIS (breaking into sweats), PRESYNCOPE (feeling like is going to pass out) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications included.  Treatment medications like Claritin (Loratadine) is used for vertigo.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Pruritus, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (increased blood pressure), PRURITUS (itchy) and VACCINATION SITE PAIN (soreness in arm at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LOSARTAN, AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 27-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 BLOOD PRESSURE INCREASED (increased blood pressure), PRURITUS (itchy) and VACCINATION SITE PAIN (soreness in arm at injection site). At the time of the report, BLOOD PRESSURE INCREASED (increased blood pressure), PRURITUS (itchy) and VACCINATION SITE PAIN (soreness in arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested covid positive 25 days after first dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Tested covid positive 25 days after first dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested covid positive 25 days after first dose.). At the time of the report, COVID-19 (Tested covid positive 25 days after first dose.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant was provided. Patient treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Myalgia, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Keeps her up at night), CHEST PAIN (Chest pain under left breast), PAIN (Pain is pretty intense) and MYALGIA (Aching and muscle pain in her legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mitral valve prolapse (Patient had a history of mitral valve prolapse which she has had for several years.). Concomitant products included IBUPROFEN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FEELING ABNORMAL (Keeps her up at night), PAIN (Pain is pretty intense) and MYALGIA (Aching and muscle pain in her legs). On 13-Mar-2021, the patient experienced CHEST PAIN (Chest pain under left breast). At the time of the report, FEELING ABNORMAL (Keeps her up at night), CHEST PAIN (Chest pain under left breast), PAIN (Pain is pretty intense) and MYALGIA (Aching and muscle pain in her legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (covid 19) in a 78-year-old male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: postive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment medication: Regeneron therapy
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nasopharyngitis, Pyrexia
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (cold), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 immunisation.     The patient's past medical history included No adverse event. Concomitant products included RIVAROXABAN (XARELTO), ATEZOLIZUMAB, CARBOPLATIN, MORPHINE SULFATE, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), PRIMIDONE, FLUOXETINE, ONDANSETRON, PROCHLORPERAZINE (COMPAZINE SPANSULE), RANITIDINE and ALPRAZOLAM (XANAX) for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, NASOPHARYNGITIS (cold), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient experienced a wave of symptoms. Concomitant information included Unisom and Albuterol inhaler and nebulizer. Treatment was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-054186 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054186:
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling). At the time of the report, PARAESTHESIA (tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided.   No treatment information was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Moderna Covid-19 vaccine at the age of 17; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at the age of 17) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at the age of 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received Moderna Covid-19 vaccine at the age of 17) 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.   This report refers to a case of Inappropriate age at vaccine administered, for mRNA-1273, lot #: unknown,  with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate age at vaccine administered, for mRNA-1273, lot #: unknown,  with no associated AEs.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; chills; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had history of covid-19 six month back was noted.).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, PYREXIA (Fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Body temperature increased: 102 (High) fever, 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Myalgia, Pain in extremity, Pruritus
Clinical narrative: Pain down her left arm; Red and itchy down her arm; Red and itchy down her arm; Low grade fever of 101 or less; Pain all over her body; Soreness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain down her left arm), ERYTHEMA (Red and itchy down her arm), PRURITUS (Red and itchy down her arm), VACCINATION SITE PAIN (Soreness around injection site) and PYREXIA (Low grade fever of 101 or less) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness around injection site) and MYALGIA (Pain all over her body). On 18-Mar-2021, the patient experienced PYREXIA (Low grade fever of 101 or less). On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain down her left arm), ERYTHEMA (Red and itchy down her arm) and PRURITUS (Red and itchy down her arm). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Pain, at an unspecified dose and frequency. On 18-Mar-2021, PYREXIA (Low grade fever of 101 or less) and MYALGIA (Pain all over her body) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain down her left arm), ERYTHEMA (Red and itchy down her arm), PRURITUS (Red and itchy down her arm) and VACCINATION SITE PAIN (Soreness around injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101 (High) Body temperature was 101 degree Fahrenheit or less.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Pain down her left arm; Red and itchy down her arm; Red and itchy down her arm; Low grade fever of 101 or less; Pain all over her body; Soreness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain down her left arm), ERYTHEMA (Red and itchy down her arm), PRURITUS (Red and itchy down her arm), VACCINATION SITE PAIN (Soreness around injection site) and PYREXIA (Low grade fever of 101 or less) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness around injection site) and MYALGIA (Pain all over her body). On 18-Mar-2021, the patient experienced PYREXIA (Low grade fever of 101 or less). On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain down her left arm), ERYTHEMA (Red and itchy down her arm) and PRURITUS (Red and itchy down her arm). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Pain, at an unspecified dose and frequency. On 18-Mar-2021, PYREXIA (Low grade fever of 101 or less) and MYALGIA (Pain all over her body) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain down her left arm), ERYTHEMA (Red and itchy down her arm), PRURITUS (Red and itchy down her arm) and VACCINATION SITE PAIN (Soreness around injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 101 (High) Body temperature was 101 degree Fahrenheit or less.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: more than 36 days without receiving second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days without receiving second dose) 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 07-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days without receiving second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days without receiving second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Malaise, Muscle spasms
Clinical narrative: Bodyache; Painful to walk; Muscle spasm; Sick feeling; Soreness of body; Chills; High Fever; Fatigued; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Bodyache), GAIT DISTURBANCE (Painful to walk), MUSCLE SPASMS (Muscle spasm), MALAISE (Sick feeling) and PAIN (Soreness of body) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by reporter.  Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and FISH OIL for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (Bodyache), GAIT DISTURBANCE (Painful to walk), MUSCLE SPASMS (Muscle spasm), MALAISE (Sick feeling), PAIN (Soreness of body), CHILLS (Chills), PYREXIA (High Fever) and FATIGUE (Fatigued). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN (Bodyache), GAIT DISTURBANCE (Painful to walk), MUSCLE SPASMS (Muscle spasm), MALAISE (Sick feeling), CHILLS (Chills), PYREXIA (High Fever) and FATIGUE (Fatigued) had resolved and PAIN (Soreness of body) 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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Bodyache; Painful to walk; Muscle spasm; Sick feeling; Soreness of body; Chills; High Fever; Fatigued; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Bodyache), GAIT DISTURBANCE (Painful to walk), MUSCLE SPASMS (Muscle spasm), MALAISE (Sick feeling) and PAIN (Soreness of body) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by reporter.  Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and FISH OIL for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (Bodyache), GAIT DISTURBANCE (Painful to walk), MUSCLE SPASMS (Muscle spasm), MALAISE (Sick feeling), PAIN (Soreness of body), CHILLS (Chills), PYREXIA (High Fever) and FATIGUE (Fatigued). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN (Bodyache), GAIT DISTURBANCE (Painful to walk), MUSCLE SPASMS (Muscle spasm), MALAISE (Sick feeling), CHILLS (Chills), PYREXIA (High Fever) and FATIGUE (Fatigued) had resolved and PAIN (Soreness of body) 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.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: feeling lots of malaise; dizziness; short of breath; lots of sleep; headache; fever; lots of chills; lots of tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling lots of malaise), DIZZINESS (dizziness), DYSPNOEA (short of breath), HYPERSOMNIA (lots of sleep) and HEADACHE (headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MALAISE (feeling lots of malaise), DIZZINESS (dizziness), DYSPNOEA (short of breath), HYPERSOMNIA (lots of sleep), HEADACHE (headache), PYREXIA (fever), CHILLS (lots of chills) and FATIGUE (lots of tiredness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, MALAISE (feeling lots of malaise), DIZZINESS (dizziness), DYSPNOEA (short of breath), HYPERSOMNIA (lots of sleep), HEADACHE (headache), PYREXIA (fever), CHILLS (lots of chills) and FATIGUE (lots of tiredness) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Malaise, Pyrexia
Clinical narrative: feeling lots of malaise; dizziness; short of breath; lots of sleep; headache; fever; lots of chills; lots of tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling lots of malaise), DIZZINESS (dizziness), DYSPNOEA (short of breath), HYPERSOMNIA (lots of sleep) and HEADACHE (headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MALAISE (feeling lots of malaise), DIZZINESS (dizziness), DYSPNOEA (short of breath), HYPERSOMNIA (lots of sleep), HEADACHE (headache), PYREXIA (fever), CHILLS (lots of chills) and FATIGUE (lots of tiredness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, MALAISE (feeling lots of malaise), DIZZINESS (dizziness), DYSPNOEA (short of breath), HYPERSOMNIA (lots of sleep), HEADACHE (headache), PYREXIA (fever), CHILLS (lots of chills) and FATIGUE (lots of tiredness) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00122073) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (little sore arm). On 02-Mar-2021, PAIN IN EXTREMITY (little sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-054748 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up contained no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054748:wife Case
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Hurting in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Hurting in the injection site) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045a21a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included INSULIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (Hurting in the injection site). On 22-Mar-2021, VACCINATION SITE PAIN (Hurting in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included high blood pressure medication.  The patent did not receive any treatment medication.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was aching/ sore), PERIPHERAL SWELLING (Swollen), ASTHENIA (Weakness), BACK PAIN (Her upper back is in pain) and PALPITATIONS (Her heart was racing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 26-Mar-2020.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was aching/ sore) and PERIPHERAL SWELLING (Swollen). On 15-Mar-2021, the patient experienced ASTHENIA (Weakness), FATIGUE (Began experiencing fatigue), HEADACHE (Headaches) and ARTHRALGIA (Her joints hurt). On 22-Mar-2021, the patient experienced BACK PAIN (Her upper back is in pain) and PALPITATIONS (Her heart was racing). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) (oral) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was aching/ sore), PERIPHERAL SWELLING (Swollen), ASTHENIA (Weakness), BACK PAIN (Her upper back is in pain), PALPITATIONS (Her heart was racing), FATIGUE (Began experiencing fatigue), HEADACHE (Headaches) and ARTHRALGIA (Her joints hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was aching/ sore), PERIPHERAL SWELLING (Swollen), ASTHENIA (Weakness), BACK PAIN (Her upper back is in pain) and PALPITATIONS (Her heart was racing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 26-Mar-2020.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was aching/ sore) and PERIPHERAL SWELLING (Swollen). On 15-Mar-2021, the patient experienced ASTHENIA (Weakness), FATIGUE (Began experiencing fatigue), HEADACHE (Headaches) and ARTHRALGIA (Her joints hurt). On 22-Mar-2021, the patient experienced BACK PAIN (Her upper back is in pain) and PALPITATIONS (Her heart was racing). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) (oral) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was aching/ sore), PERIPHERAL SWELLING (Swollen), ASTHENIA (Weakness), BACK PAIN (Her upper back is in pain), PALPITATIONS (Her heart was racing), FATIGUE (Began experiencing fatigue), HEADACHE (Headaches) and ARTHRALGIA (Her joints hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 08-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved.        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.   Relevant concomitant medications included medications for blood pressure, HIV medicine, allergy pills, appetite pills and stomach pills. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-054413 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: form was attached and patient declined further follow up.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054413:second dose
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Malaise, Nausea, Retching
Clinical narrative: constantly salivating, spitting; gagging; stomach pain; not able to function very well; headache; extreme nausea; This spontaneous case was reported by a physician assistant and describes the occurrence of SALIVARY HYPERSECRETION (constantly salivating, spitting), RETCHING (gagging), ABDOMINAL PAIN UPPER (stomach pain), MALAISE (not able to function very well) and HEADACHE (headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Anxiety. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX (YAZ [DROSPIRENONE;ETHINYLESTRADIOL BETADEX]) for Birth control, ESCITALOPRAM OXALATE (LEXAPRO) for Depression and Anxiety.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced SALIVARY HYPERSECRETION (constantly salivating, spitting), RETCHING (gagging), ABDOMINAL PAIN UPPER (stomach pain), MALAISE (not able to function very well), HEADACHE (headache) and NAUSEA (extreme nausea). At the time of the report, SALIVARY HYPERSECRETION (constantly salivating, spitting), RETCHING (gagging), ABDOMINAL PAIN UPPER (stomach pain), MALAISE (not able to function very well), HEADACHE (headache) and NAUSEA (extreme nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Salivary hypersecretion
Clinical narrative: constantly salivating, spitting; gagging; stomach pain; not able to function very well; headache; extreme nausea; This spontaneous case was reported by a physician assistant and describes the occurrence of SALIVARY HYPERSECRETION (constantly salivating, spitting), RETCHING (gagging), ABDOMINAL PAIN UPPER (stomach pain), MALAISE (not able to function very well) and HEADACHE (headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression and Anxiety. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX (YAZ [DROSPIRENONE;ETHINYLESTRADIOL BETADEX]) for Birth control, ESCITALOPRAM OXALATE (LEXAPRO) for Depression and Anxiety.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced SALIVARY HYPERSECRETION (constantly salivating, spitting), RETCHING (gagging), ABDOMINAL PAIN UPPER (stomach pain), MALAISE (not able to function very well), HEADACHE (headache) and NAUSEA (extreme nausea). At the time of the report, SALIVARY HYPERSECRETION (constantly salivating, spitting), RETCHING (gagging), ABDOMINAL PAIN UPPER (stomach pain), MALAISE (not able to function very well), HEADACHE (headache) and NAUSEA (extreme nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: red in color; mild rash/annoying; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red in color) and RASH (mild rash/annoying) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A.) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red in color) and RASH (mild rash/annoying). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (red in color) and RASH (mild rash/annoying) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.