Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hepatitis C virus test, Insomnia, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Does not seem to be able to recover her energy level back; Loose Stool/ soft stool; Rash on the Neck; Fatigue; Rash on the Injection Site; fever; chills; nausea; body aches; headache/ extreme headache; injection site itches; Weak legs; sleeplessness; stiff neck; This spontaneous case was reported by a consumer and describes the occurrence of FAECES SOFT (Loose Stool/ soft stool), MUSCULAR WEAKNESS (Weak legs), ASTHENIA (Does not seem to be able to recover her energy level back), INSOMNIA (sleeplessness) and MUSCULOSKELETAL STIFFNESS (stiff neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anemic (Mild anemia.), Gastroesophageal reflux disease since 1980, Herpes virus infection, Fibromyalgia since 1990 and Erosive osteoarthritis since 2000. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for Gastroesophageal reflux disease, VALACYCLOVIR [VALACICLOVIR] for Herpes virus infection.   On 06-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Weak legs), HEADACHE (headache/ extreme headache), CHILLS (chills) and NAUSEA (nausea). 07-Mar-2021, the patient experienced INSOMNIA (sleeplessness) and VACCINATION SITE PRURITUS (injection site itches). 07-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and MYALGIA (body aches). On 07-Mar-2021 at 10:30 PM, the patient experienced PYREXIA (fever). On 10-Mar-2021, the patient experienced FAECES SOFT (Loose Stool/ soft stool), RASH (Rash on the Neck), FATIGUE (Fatigue) and VACCINATION SITE RASH (Rash on the Injection Site). On 05-Apr-2021, the patient experienced ASTHENIA (Does not seem to be able to recover her energy level back). On 10-Mar-2021, MUSCULAR WEAKNESS (Weak legs), HEADACHE (headache/ extreme headache), CHILLS (chills) and NAUSEA (nausea) had resolved. On 15-Mar-2021, RASH (Rash on the Neck) and VACCINATION SITE RASH (Rash on the Injection Site) had resolved. At the time of the report, FAECES SOFT (Loose Stool/ soft stool) and FATIGUE (Fatigue) had not resolved and ASTHENIA (Does not seem to be able to recover her energy level back), INSOMNIA (sleeplessness), MUSCULOSKELETAL STIFFNESS (stiff neck), VACCINATION SITE PRURITUS (injection site itches), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood iron: Negative. On an unknown date, Hepatitis C virus test: Negative. On an unknown date, Neutrophil count: Low. On an unknown date, SARS-CoV-2 test: Negative. On an unknown date, Vitamin B12: Negative. On an unknown date, White blood cell count: Low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCULOSKELETAL STIFFNESS (stiff neck) to be possibly related. No further causality assessments were provided for FAECES SOFT (Loose Stool/ soft stool), MUSCULAR WEAKNESS (Weak legs), ASTHENIA (Does not seem to be able to recover her energy level back), INSOMNIA (sleeplessness), RASH (Rash on the Neck), VACCINATION SITE PRURITUS (injection site itches), FATIGUE (Fatigue), HEADACHE (headache/ extreme headache), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE RASH (Rash on the Injection Site) and MYALGIA (body aches).    Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient's demographics, concurrent condition, dose 1 details, events (muscle stiffness and pyrexia) and lab data was updated. On 15-Jul-2021: Follow up received included updated information of concomitant drug and event.