Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Flatulence, Headache, Limb discomfort
Clinical narrative: horrible sore throat; lost their taste and smell; lost their taste and smell; winded; dizziness; slight cough; sinus congestion; bad headache; Recently contracted COVID; Lack of efficacy; Arm pain/Dead arm; fatigue; Body aches/horrible body aches; arm felt heavy; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm felt heavy), OROPHARYNGEAL PAIN (horrible sore throat), ANOSMIA (lost their taste and smell), AGEUSIA (lost their taste and smell) and FLATULENCE (winded) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced LIMB DISCOMFORT (arm felt heavy), PAIN IN EXTREMITY (Arm pain/Dead arm), FATIGUE (fatigue) and MYALGIA (Body aches/horrible body aches). On 02-Aug-2021, the patient experienced COVID-19 (Recently contracted COVID) and DRUG INEFFECTIVE (Lack of efficacy). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (horrible sore throat), ANOSMIA (lost their taste and smell), AGEUSIA (lost their taste and smell), FLATULENCE (winded), DIZZINESS (dizziness), COUGH (slight cough), SINUS CONGESTION (sinus congestion) and HEADACHE (bad headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 UNK and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 UNK. On 19-Mar-2021, LIMB DISCOMFORT (arm felt heavy) outcome was unknown, PAIN IN EXTREMITY (Arm pain/Dead arm), FATIGUE (fatigue) and MYALGIA (Body aches/horrible body aches) had resolved. At the time of the report, OROPHARYNGEAL PAIN (horrible sore throat), ANOSMIA (lost their taste and smell), AGEUSIA (lost their taste and smell), FLATULENCE (winded), DIZZINESS (dizziness), COUGH (slight cough), SINUS CONGESTION (sinus congestion), COVID-19 (Recently contracted COVID), DRUG INEFFECTIVE (Lack of efficacy) and HEADACHE (bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: positive (Positive) nasopharyngeal sample- rapid results.         Patient was reported to develop no events after the first dose. Patient was reported to take a generic allergy medication daily during summer months.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Live Follow up received and new event-became sick was added. On 27-Sep-2021: Follow up was received. COVID-19 test date was added.; Sender's Comments: This case concerns a  46-year-old, male patient with no disclosed medical history who experienced the unexpected events of limb discomfort, pain in extremity and Covid 19 (AESI) and expected events of headache, faigue and myalgia. The events limb discomfort, pain in extremity, fatigue and myalgia occurred approximately 1 day after the second dose of Moderna vaccine. The event Drug ineffective was considered an additional event after patient was diagnosed with Covid 19 approximately 5 months after the second dose. During the time patient had Covid, he experienced anosmia, ageusia, oropharyngeal pain, dizziness, flatulence, cough,headache and sinus congestion. The rechallenge was unknown since no information about the first dose was disclosed. The events fatigue and myalgia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this  report.