Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Feeling cold, Headache
Clinical narrative: didn't get my strength back totally; achiness/ sore; had a reaction to the second Moderna COVID-19 vaccination; Freezie; anorexia; Temperature elevated; Rigors; severe headache; queasy/nausea; vomiting; Body aching; Painful shoulder; Fatigue; trembling/shaking/severe shaking/shaking so hard it was unbelievably painful; muscles were contracting/muscle contractions everywhere; diarrhea; cramping; felt like I dislocated my right shoulder; she was anorexic; terribly weak/weak/still felt weak at times/remained weak; no body felt as bad as I did/wasn't feeling 100%; site tenderness; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (had a reaction to the second Moderna COVID-19 vaccination), TENDERNESS (site tenderness), TREMOR (trembling/shaking/severe shaking/shaking so hard it was unbelievably painful), MUSCLE CONTRACTIONS INVOLUNTARY (muscles were contracting/muscle contractions everywhere) and DIARRHOEA (diarrhea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma since 1998, Hypercholesterolemia since 2017, Autoimmune disorder (autoimmune disorder causes urticaria flares.) since 1998, Drug allergy (Allergic to NSAIDs which triggers asthma), Ache, Headache, Sleep disorder, Flu, Central sleep apnea syndrome since December 2016, Drug allergy (Sulfa), Drug allergy (amoxicillin), Drug allergy (Tequin), Drug allergy (Biaxin), Osteoarthritis since December 2020 and Chronic renal failure (chronic renal failure stage 3B) since December 2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) from 2010 to an unknown date for Anticoagulant therapy, ALBUTEROL [SALBUTAMOL] from 1998 to an unknown date for Asthma, METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Asthmatic, OXYMETAZOLINE from January 2017 to an unknown date for Central sleep apnea syndrome, AZITHROMYCIN for Flu, SIMVASTATIN from 2017 to an unknown date for Hypercholesterolemia, MONTELUKAST from 2017 to an unknown date for Intrinsic asthma, MELATONIN from 2010 to an unknown date for Sleep disorder, MULTIVITAMIN [VITAMINS NOS] from 2000 to an unknown date, CALCIUM from 2000 to an unknown date, CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]) from 2000 to an unknown date, ACETAMINOPHEN from 1998 to an unknown date and FLUTICASONE from January 2017 to an unknown date for an unknown indication.   On 03-Mar-2021 at 12:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TENDERNESS (site tenderness). On 01-Apr-2021, the patient experienced TREMOR (trembling/shaking/severe shaking/shaking so hard it was unbelievably painful), MUSCLE CONTRACTIONS INVOLUNTARY (muscles were contracting/muscle contractions everywhere), DIARRHOEA (diarrhea), MUSCLE SPASMS (cramping), MUSCULOSKELETAL DISCOMFORT (felt like I dislocated my right shoulder), DECREASED APPETITE (she was anorexic), ASTHENIA (terribly weak/weak/still felt weak at times/remained weak), FEELING ABNORMAL (no body felt as bad as I did/wasn't feeling 100%), FEELING COLD (Freezie), DECREASED APPETITE (anorexia), BODY TEMPERATURE INCREASED (Temperature elevated), CHILLS (Rigors), HEADACHE (severe headache), NAUSEA (queasy/nausea), VOMITING (vomiting), MYALGIA (Body aching), ARTHRALGIA (Painful shoulder) and FATIGUE (Fatigue). On an unknown date, the patient experienced VACCINATION COMPLICATION (had a reaction to the second Moderna COVID-19 vaccination), MOBILITY DECREASED (didn't get my strength back totally) and PAIN (achiness/ sore). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Ache, at a dose of 650 mg as required. On 03-Apr-2021, DIARRHOEA (diarrhea), DECREASED APPETITE (she was anorexic), DECREASED APPETITE (anorexia), HEADACHE (severe headache) and NAUSEA (queasy/nausea) had resolved. At the time of the report, VACCINATION COMPLICATION (had a reaction to the second Moderna COVID-19 vaccination), TENDERNESS (site tenderness), TREMOR (trembling/shaking/severe shaking/shaking so hard it was unbelievably painful), MUSCLE CONTRACTIONS INVOLUNTARY (muscles were contracting/muscle contractions everywhere), MUSCLE SPASMS (cramping), MUSCULOSKELETAL DISCOMFORT (felt like I dislocated my right shoulder), ASTHENIA (terribly weak/weak/still felt weak at times/remained weak), FEELING ABNORMAL (no body felt as bad as I did/wasn't feeling 100%), MOBILITY DECREASED (didn't get my strength back totally), PAIN (achiness/ sore), CHILLS (Rigors) and VOMITING (vomiting) was resolving and FEELING COLD (Freezie), BODY TEMPERATURE INCREASED (Temperature elevated), MYALGIA (Body aching), ARTHRALGIA (Painful shoulder) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included decongestant antihistamine.   This case was linked to MOD-2021-300234 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow Up information was received on 06-Sep-2021 Updated Patient demographics, medical history, concomitant medications, events and event outcome.