chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full of allergies; Hives from her shoulders to the top/full of hives; Face swelled; Throat closed up; Inflammation; Swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Full of allergies), URTICARIA (Hives from her shoulders to the top/full of hives), SWELLING FACE (Face swelled), THROAT TIGHTNESS (Throat closed up) and INFLAMMATION (Inflammation) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016CA1A) 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 THYROID for an unknown indication.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced HYPERSENSITIVITY (Full of allergies), URTICARIA (Hives from her shoulders to the top/full of hives), SWELLING FACE (Face swelled), THROAT TIGHTNESS (Throat closed up), INFLAMMATION (Inflammation) and LIP SWELLING (Swollen lips). The patient was treated with PREDNISONE for Allergy, at a dose of 10 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) for Allergy, at an unspecified dose and frequency and AMOXICILLIN TRIHYDRATE (AMOXIDIN) for Allergy, at an unspecified dose and frequency. On 09-May-2021, LIP SWELLING (Swollen lips) had resolved. At the time of the report, HYPERSENSITIVITY (Full of allergies), URTICARIA (Hives from her shoulders to the top/full of hives), SWELLING FACE (Face swelled), THROAT TIGHTNESS (Throat closed up) and INFLAMMATION (Inflammation) 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.   The patient had picket at the pharmacy and injections at the hospital   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Document received and does not contain any new information
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of relaxation, Pyrexia
Clinical narrative: "felt good"; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION ("felt good") and PYREXIA (fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included IXEKIZUMAB (TALTZ) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced FEELING OF RELAXATION ("felt good"). 08-May-2021, the patient experienced PYREXIA (fever). At the time of the report, FEELING OF RELAXATION ("felt good") outcome was unknown and PYREXIA (fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Ibuprofen.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Allergic respiratory disease, Rash, Rash erythematous
Clinical narrative: Allergic reaction to pollen in the air; Cherry red rash; body rash; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGIC RESPIRATORY DISEASE (Allergic reaction to pollen in the air), RASH ERYTHEMATOUS (Cherry red rash) and RASH (body rash) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced ALLERGIC RESPIRATORY DISEASE (Allergic reaction to pollen in the air), RASH ERYTHEMATOUS (Cherry red rash) and RASH (body rash). The patient was treated with METHYLPREDNISOLONE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ALLERGIC RESPIRATORY DISEASE (Allergic reaction to pollen in the air), RASH ERYTHEMATOUS (Cherry red rash) and RASH (body rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Aching; Headache; there's no fever only chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching), HEADACHE (Headache) and CHILLS (there's no fever only chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN), AZATHIOPRINE and VITAMIN D NOS for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN (Aching), HEADACHE (Headache) and CHILLS (there's no fever only chills). At the time of the report, PAIN (Aching), HEADACHE (Headache) and CHILLS (there's no fever only chills) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication AZOR to treat blood pressure was reported. Treatment medication is not reported.   This case was linked to MOD-2021-116402 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site erythema, Vaccination site lymphadenopathy, Vaccination site rash
Clinical narrative: painful swelling of the lymph nodes in arm pit area of injected arm; painful swelling of the lymph nodes in arm pit area of injected arm; red rash around the injection site area; red rash around the injection site area; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE LYMPHADENOPATHY (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE RASH (red rash around the injection site area) and VACCINATION SITE ERYTHEMA (red rash around the injection site area) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPH NODE PAIN (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE LYMPHADENOPATHY (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE RASH (red rash around the injection site area) and VACCINATION SITE ERYTHEMA (red rash around the injection site area). At the time of the report, LYMPH NODE PAIN (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE LYMPHADENOPATHY (painful swelling of the lymph nodes in arm pit area of injected arm), VACCINATION SITE RASH (red rash around the injection site area) and VACCINATION SITE ERYTHEMA (red rash around the injection site area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication were provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: delayed itching rash around site of arm injectiion; delayed itching rash around site of arm injectiion; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (delayed itching rash around site of arm injectiion) and VACCINATION SITE RASH (delayed itching rash around site of arm injectiion) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (delayed itching rash around site of arm injectiion) and VACCINATION SITE RASH (delayed itching rash around site of arm injectiion). At the time of the report, VACCINATION SITE PRURITUS (delayed itching rash around site of arm injectiion) and VACCINATION SITE RASH (delayed itching rash around site of arm injectiion) had resolved.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever at 100 degrees F; extreme headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever at 100 degrees F), HEADACHE (extreme headache) and CHILLS (Chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Azor                                                           for her blood pressure for Blood pressure high, VITAMIN D NOS, CALCIUM CARBONATE, COLECALCIFEROL (Hydroxychloroquin) and AZATHIOPRINE for an unknown indication.    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PYREXIA (fever at 100 degrees F), HEADACHE (extreme headache) and CHILLS (Chills). At the time of the report, PYREXIA (fever at 100 degrees F), HEADACHE (extreme headache) and CHILLS (Chills) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details include 200mg of Advil total of 4 tablets after she got home   This case was linked to MOD-2021-116398.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Severe hair loss (bold on top of head); This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Severe hair loss (bold on top of head)) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Severe hair loss (bold on top of head)). The patient was treated with MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) at a dose of 1 dosage form. At the time of the report, ALOPECIA (Severe hair loss (bold on top of head)) outcome was unknown. Not Provided          The action taken with mRNA-1273 with the events was considered as not applicable No concomitant medications was provided.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: NNI, email or fax number requested from consumer, consumer declined to share email address
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose administered on 21 days after the first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered on 21 days after the first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered on 21 days after the first shot). On 10-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered on 21 days after the first shot) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chills, Dyspnoea, Pain in extremity
Clinical narrative: I felt shortness of breath; I loss taste and smell,"I can only taste salt"; fever; chills and stuffs; My arm hurting; Weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm hurting), ASTHENIA (Weak), AGEUSIA (I loss taste and smell,"I can only taste salt"), DYSPNOEA (I felt shortness of breath) and PYREXIA (fever) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced PAIN IN EXTREMITY (My arm hurting), ASTHENIA (Weak), PYREXIA (fever) and CHILLS (chills and stuffs). On 05-May-2021, the patient experienced AGEUSIA (I loss taste and smell,"I can only taste salt"). On 06-May-2021, the patient experienced DYSPNOEA (I felt shortness of breath). On 06-May-2021, ASTHENIA (Weak), PYREXIA (fever) and CHILLS (chills and stuffs) had resolved. At the time of the report, PAIN IN EXTREMITY (My arm hurting), AGEUSIA (I loss taste and smell,"I can only taste salt") and DYSPNOEA (I felt shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I felt shortness of breath; I loss taste and smell,"I can only taste salt"; fever; chills and stuffs; My arm hurting; Weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm hurting), ASTHENIA (Weak), AGEUSIA (I loss taste and smell,"I can only taste salt"), DYSPNOEA (I felt shortness of breath) and PYREXIA (fever) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced PAIN IN EXTREMITY (My arm hurting), ASTHENIA (Weak), PYREXIA (fever) and CHILLS (chills and stuffs). On 05-May-2021, the patient experienced AGEUSIA (I loss taste and smell,"I can only taste salt"). On 06-May-2021, the patient experienced DYSPNOEA (I felt shortness of breath). On 06-May-2021, ASTHENIA (Weak), PYREXIA (fever) and CHILLS (chills and stuffs) had resolved. At the time of the report, PAIN IN EXTREMITY (My arm hurting), AGEUSIA (I loss taste and smell,"I can only taste salt") and DYSPNOEA (I felt shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza like illness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of influenza-like illness (flu-like symptoms) and diarrhea in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025B21A and 005C21A) for COVID-19 immunization. No medical history reported. On Apr 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 1, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 1, 2021, patient experienced influenza-like illness (flu-like symptoms) and diarrhea. On May 3, 2021, influenza-like illness (flu-like symptoms) and diarrhea resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. This case linked to MOD-2021-080333 (patient link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received first dose on 12Mar2021 and has not received second dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received first dose on 12Mar2021 and has not received second dose yet) 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. On 12-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (received first dose on 12Mar2021 and has not received second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose on 12Mar2021 and has not received second dose yet) 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 medication details was reported. No treatment medication details was reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Myalgia, Tonsillar inflammation
Clinical narrative: Inflamed tonsils; Anxiety; Sore arms; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR INFLAMMATION (Inflamed tonsils), ANXIETY (Anxiety) and MYALGIA (Sore arms) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No reported medical history reported.  The patient's past medical history included No adverse reaction.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced TONSILLAR INFLAMMATION (Inflamed tonsils), ANXIETY (Anxiety) and MYALGIA (Sore arms). At the time of the report, TONSILLAR INFLAMMATION (Inflamed tonsils), ANXIETY (Anxiety) and MYALGIA (Sore arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose 2 weeks after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after 1st dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C218) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LISINOPRIL and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose appointment; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-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 PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: skipped the second dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (skipped the second dose of vaccination) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-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 PRODUCT DOSE OMISSION ISSUE (skipped the second dose of vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (skipped the second dose of vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, COVID-19: positive (Positive) tested positive for corona.         No concomitant medication was reported. The treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.  patient received a plasma infusion therapy on 13 February 2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Inappropriate schedule of product administration, Malaise, Nasopharyngitis, Upper-airway cough syndrome
Clinical narrative: postnasal drip; not feeling well/feels like she is not getting any better; postponed her second dose of Moderna COVID-19 Vaccine; been coughing/ hacking cough; has horrible cold/ developed a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (has horrible cold/ developed a cold), UPPER-AIRWAY COUGH SYNDROME (postnasal drip), MALAISE (not feeling well/feels like she is not getting any better), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (postponed her second dose of Moderna COVID-19 Vaccine) and COUGH (been coughing/ hacking cough) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced NASOPHARYNGITIS (has horrible cold/ developed a cold) and COUGH (been coughing/ hacking cough). On an unknown date, the patient experienced UPPER-AIRWAY COUGH SYNDROME (postnasal drip), MALAISE (not feeling well/feels like she is not getting any better) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (postponed her second dose of Moderna COVID-19 Vaccine). The patient was treated with AMOXICILLIN on 07-May-2021 at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE DM) on 15-May-2021 at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (has horrible cold/ developed a cold), UPPER-AIRWAY COUGH SYNDROME (postnasal drip), MALAISE (not feeling well/feels like she is not getting any better) and COUGH (been coughing/ hacking cough) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (postponed her second dose of Moderna COVID-19 Vaccine) 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 concomitant medications were mentioned.    Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received on 17-may-2021 new AE updated. On 24-May-2021: Non-Significant follow up received on 24-may-2021,  includes vaccination facility information and second dose postponed.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hypersomnia, Pyrexia, Tremor
Clinical narrative: slept for 40 hours; shaking so bad; fever of 103; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for 40 hours), TREMOR (shaking so bad), PYREXIA (fever of 103) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced HYPERSOMNIA (slept for 40 hours), TREMOR (shaking so bad), PYREXIA (fever of 103) and HEADACHE (headache). On 25-Feb-2021, HYPERSOMNIA (slept for 40 hours), TREMOR (shaking so bad), PYREXIA (fever of 103) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 103 (High) fever of 103.         Concomitant product use was not provided by the reporter.   Patient took pain medication (oxy).  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeding disorder, Myalgia, Nausea
Clinical narrative: Red Injection Site about 3" round; Vomiting; Tired; nausea; Muscle Pain; Joint pain; Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before; Not Eating; Swollen Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before), FEEDING DISORDER (Not Eating), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site about 3" round) and VOMITING (Vomiting) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen Injection Site). On 04-May-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before), FEEDING DISORDER (Not Eating), VACCINATION SITE ERYTHEMA (Red Injection Site about 3" round), VOMITING (Vomiting), FATIGUE (Tired), NAUSEA (nausea), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION SITE WARMTH (Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before) was resolving, FEEDING DISORDER (Not Eating), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site about 3" round), FATIGUE (Tired), NAUSEA (nausea), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint pain) had not resolved and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information not provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth, Vomiting
Clinical narrative: Red Injection Site about 3" round; Vomiting; Tired; nausea; Muscle Pain; Joint pain; Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before; Not Eating; Swollen Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before), FEEDING DISORDER (Not Eating), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site about 3" round) and VOMITING (Vomiting) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen Injection Site). On 04-May-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before), FEEDING DISORDER (Not Eating), VACCINATION SITE ERYTHEMA (Red Injection Site about 3" round), VOMITING (Vomiting), FATIGUE (Tired), NAUSEA (nausea), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION SITE WARMTH (Warm to the Touch Injection Site,Injection Site Not As Hot as it was Before) was resolving, FEEDING DISORDER (Not Eating), VACCINATION SITE SWELLING (Swollen Injection Site), VACCINATION SITE ERYTHEMA (Red Injection Site about 3" round), FATIGUE (Tired), NAUSEA (nausea), MYALGIA (Muscle Pain) and ARTHRALGIA (Joint pain) had not resolved and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face, Vaccination site rash
Clinical narrative: around the injection site there was a rash; woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.; woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (around the injection site there was a rash), SWELLING FACE (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.) and EYE SWELLING (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), VITAMIN D NOS, COLLAGEN, MULTIVITAMIN [VITAMINS NOS] and WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]) for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced SWELLING FACE (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.) and EYE SWELLING (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.). On 23-Apr-2021, the patient experienced VACCINATION SITE RASH (around the injection site there was a rash). In April 2021, VACCINATION SITE RASH (around the injection site there was a rash) had resolved. On 17-Apr-2021, SWELLING FACE (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.) and EYE SWELLING (woke up in the night and could feel swelling around her face and her eyes being almost swollen shut.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information include, Benadryl, cold compress.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Product dose omission issue, Rash
Clinical narrative: He developed slight rash underneath injection site 1-2 weeks after receiving vaccine/ Rash went away in 1-2 weeks; He also developed stiffness in left finger joints that started 1-2 weeks after receiving 1st dose/ The stiffness in his left hand's fingers is still there; He is electing not to receive 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (He developed slight rash underneath injection site 1-2 weeks after receiving vaccine/ Rash went away in 1-2 weeks), MUSCULOSKELETAL STIFFNESS (He also developed stiffness in left finger joints that started 1-2 weeks after receiving 1st dose/ The stiffness in his left hand's fingers is still there) and PRODUCT DOSE OMISSION ISSUE (He is electing not to receive 2nd dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 10-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (He is electing not to receive 2nd dose). On an unknown date, the patient experienced RASH (He developed slight rash underneath injection site 1-2 weeks after receiving vaccine/ Rash went away in 1-2 weeks) and MUSCULOSKELETAL STIFFNESS (He also developed stiffness in left finger joints that started 1-2 weeks after receiving 1st dose/ The stiffness in his left hand's fingers is still there). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, RASH (He developed slight rash underneath injection site 1-2 weeks after receiving vaccine/ Rash went away in 1-2 weeks) had resolved and MUSCULOSKELETAL STIFFNESS (He also developed stiffness in left finger joints that started 1-2 weeks after receiving 1st dose/ The stiffness in his left hand's fingers is still there) and PRODUCT DOSE OMISSION ISSUE (He is electing not to receive 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: body aches; low grade fever of 99.9°F (lasted 6-8 hrs); chills; fatigue; my arm felt like someone hit me with baseball bat; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (low grade fever of 99.9°F (lasted 6-8 hrs)), CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (my arm felt like someone hit me with baseball bat) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (body aches), PYREXIA (low grade fever of 99.9°F (lasted 6-8 hrs)), CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (my arm felt like someone hit me with baseball bat). The patient was treated with IBUPROFEN at a dose of 600 milligram. At the time of the report, MYALGIA (body aches), PYREXIA (low grade fever of 99.9°F (lasted 6-8 hrs)), CHILLS (chills), FATIGUE (fatigue) and PAIN IN EXTREMITY (my arm felt like someone hit me with baseball bat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product details were provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old son received the Moderna Vaccine; This spontaneous case was reported by an other caregiver and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son received the Moderna Vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son received the Moderna Vaccine). On 08-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son received the Moderna Vaccine) had resolved. Not Provided          No relevant concomitant medication was reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: New event added - Dose 2 administered with no ADRs
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Rash, Vaccination site rash
Clinical narrative: Small rash on his arm; Fever; Really bad chills; Small rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small rash on his arm), PYREXIA (Fever), CHILLS (Really bad chills) and VACCINATION SITE RASH (Small rash at the injection site) in a 67-year-old male 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) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Small rash on his arm), PYREXIA (Fever), CHILLS (Really bad chills) and VACCINATION SITE RASH (Small rash at the injection site). At the time of the report, RASH (Small rash on his arm), PYREXIA (Fever), CHILLS (Really bad chills) and VACCINATION SITE RASH (Small rash at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102F, 101.3 (High) 101.3F and 100.2 (High) 100.2.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-216618 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-JUN-2021, contains reporter information(middle name), patient age, vaccination details (start date of both first and second dose), events (chills, rash), updated action taken. On 18-Jun-2021: Follow-up information received on 18-Jun-2021 contains updated laboratory details.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced COVID-19 (Tested positive for covid-19). At the time of the report, COVID-19 (Tested positive for covid-19) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chest X-ray, Chills
Clinical narrative: COVID-19; Muscle ache; coughing; chills; Headache; Fatigue; Nasal congestion; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and COUGH (coughing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (chills). On 16-Apr-2021, the patient experienced COUGH (coughing). On an unknown date, the patient experienced COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), MYALGIA (Muscle ache), HEADACHE (Headache) and FATIGUE (Fatigue). On 14-Apr-2021, CHILLS (chills) had resolved. At the time of the report, COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), COUGH (coughing), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Chest X-ray: normal (normal) Chest x-ray came back normal. On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) Nasopharyngeal positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: HCP information added as secondary reporter, confirmed positive COVID-19 test On 19-Jun-2021: Follow-up questionnaire provided AE details.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Myalgia, Nasal congestion
Clinical narrative: COVID-19; Muscle ache; coughing; chills; Headache; Fatigue; Nasal congestion; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and COUGH (coughing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (chills). On 16-Apr-2021, the patient experienced COUGH (coughing). On an unknown date, the patient experienced COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), MYALGIA (Muscle ache), HEADACHE (Headache) and FATIGUE (Fatigue). On 14-Apr-2021, CHILLS (chills) had resolved. At the time of the report, COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), COUGH (coughing), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Chest X-ray: normal (normal) Chest x-ray came back normal. On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) Nasopharyngeal positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: HCP information added as secondary reporter, confirmed positive COVID-19 test On 19-Jun-2021: Follow-up questionnaire provided AE details.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: COVID-19; Muscle ache; coughing; chills; Headache; Fatigue; Nasal congestion; Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and COUGH (coughing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced CHILLS (chills). On 16-Apr-2021, the patient experienced COUGH (coughing). On an unknown date, the patient experienced COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), MYALGIA (Muscle ache), HEADACHE (Headache) and FATIGUE (Fatigue). On 14-Apr-2021, CHILLS (chills) had resolved. At the time of the report, COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), COUGH (coughing), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Chest X-ray: normal (normal) Chest x-ray came back normal. On 22-Apr-2021, SARS-CoV-2 test: positive (Positive) Nasopharyngeal positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: HCP information added as secondary reporter, confirmed positive COVID-19 test On 19-Jun-2021: Follow-up questionnaire provided AE details.