Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Immunisation reaction, Myalgia
Clinical narrative: Tip of the tongue since then felt like it was burnt on something hot/weird tingling sensation similar to when had a allergic reaction to Allegra; Feels horrible/feels so bad; In pain; Losing sleep; 2 allergy attacks in between with sinus and drainage; Feels like she has a fever but does not have fever; Fatigue; Body aches; Muscle cramps/every single night she has leg muscles and muscles in arms twitches; Twitching/every single night she has leg muscles and muscles in arms twitches; Woke up in the middle of the night with a vibrating, tingling sensation on the left arm, left leg side of the shot (left side of the body)/every single night she has leg and arm muscles tingling; This spontaneous case was reported by a patient and describes the occurrence of ALLERGIC SINUSITIS (2 allergy attacks in between with sinus and drainage), MUSCLE SPASMS (Muscle cramps/every single night she has leg muscles and muscles in arms twitches), MUSCLE TWITCHING (Twitching/every single night she has leg muscles and muscles in arms twitches), PARAESTHESIA ORAL (Tip of the tongue since then felt like it was burnt on something hot/weird tingling sensation similar to when had a allergic reaction to Allegra) and FEELING ABNORMAL (Feels horrible/feels so bad) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 058E21A(4), 032B21A and 030A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allegra), Allergy to antibiotic (sulfa antibiotics) and Drug allergy (Compazine).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022, the patient experienced MUSCLE SPASMS (Muscle cramps/every single night she has leg muscles and muscles in arms twitches), MUSCLE TWITCHING (Twitching/every single night she has leg muscles and muscles in arms twitches), PARAESTHESIA (Woke up in the middle of the night with a vibrating, tingling sensation on the left arm, left leg side of the shot (left side of the body)/every single night she has leg and arm muscles tingling), FATIGUE (Fatigue) and MYALGIA (Body aches). On an unknown date, the patient experienced ALLERGIC SINUSITIS (2 allergy attacks in between with sinus and drainage), PARAESTHESIA ORAL (Tip of the tongue since then felt like it was burnt on something hot/weird tingling sensation similar to when had a allergic reaction to Allegra), FEELING ABNORMAL (Feels horrible/feels so bad), PAIN (In pain), INSOMNIA (Losing sleep) and PYREXIA (Feels like she has a fever but does not have fever). The patient was treated with IBUPROFEN for Myalgia, at an unspecified dose and frequency. At the time of the report, ALLERGIC SINUSITIS (2 allergy attacks in between with sinus and drainage), FEELING ABNORMAL (Feels horrible/feels so bad), PAIN (In pain), INSOMNIA (Losing sleep) and PYREXIA (Feels like she has a fever but does not have fever) outcome was unknown and MUSCLE SPASMS (Muscle cramps/every single night she has leg muscles and muscles in arms twitches), MUSCLE TWITCHING (Twitching/every single night she has leg muscles and muscles in arms twitches), PARAESTHESIA ORAL (Tip of the tongue since then felt like it was burnt on something hot/weird tingling sensation similar to when had a allergic reaction to Allegra), PARAESTHESIA (Woke up in the middle of the night with a vibrating, tingling sensation on the left arm, left leg side of the shot (left side of the body)/every single night she has leg and arm muscles tingling), FATIGUE (Fatigue) and MYALGIA (Body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood iron decreased: Low. On an unknown date, C-reactive protein: elevated. On an unknown date, Red blood cell sedimentation rate: Elevated. On an unknown date, SARS-CoV-2 test: (Negative) Negative. On an unknown date, White blood cell count: Elevated.         No concomitant medication was provided by the reporter  It was reported that the patient took 2nd booster dose and did not seem to be affected but then the following week, patient woke up in the middle of the night with a vibrating, tingling sensation on the left arm, left leg side of the shot (left side of the body). It has been ongoing since that day per the patient and experienced muscle cramps, twitching, body aches, fatigue and stated that she did not know if it was related to the shot.  The patient saw the doctor and stated that they ran test and they were sending patient to neurology and rheumatology as they don't know what it was. The patient was wearing N-95 mask every day at work and does not go out in public buildings, takes temperatures everyday as patient works in a clinic.   This case was linked to MOD-2022-607740 (Patient Link).