Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Insomnia, International normalised ratio
Clinical narrative: anxious; restless; not able to sleep; normal activities could not be complete; shortness of breath; worsening body aches; nausea; bruising on the right arm; fatigue; headaches , right sided headache; given 2.5 ml of the vaccine for 2nd booster dose; This spontaneous case was reported by a nurse and describes the occurrence of CONTUSION (bruising on the right arm), ANXIETY (anxious), RESTLESSNESS (restless), INSOMNIA (not able to sleep) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (normal activities could not be complete) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22-2A, 046L21A, 037B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastritis, Liver cirrhosis, Esophageal varices (without bleeding), Hypertension, Hypothyroidism, Obstructive sleep apnea syndrome, Thyroid carcinoma, Breast cancer female, Depression, Type II diabetes mellitus inadequate control, Hyperlipidemia, Iron deficiency (HCP not sure whether these conditions occurred prior to taking the vaccine.) and Hip arthropathy. Concomitant products included ATORVASTATIN, FUROSEMIDE (LASIX [FUROSEMIDE]), ASCORBIC ACID, BETA VULGARIS ROOT, IRON AMINO ACID CHELATE, ROSA CANINA FRUIT, RUBUS IDAEUS LEAF (IRON SUPPLEMENT WITH VIT C & HERBS), HYDROXYZINE, SITAGLIPTIN PHOSPHATE (JANUVIA), EMPAGLIFLOZIN (JARDIANCE), INSULIN DETEMIR (LEVEMIR PENFILL), LEVOTHYROXINE and METFORMIN for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 28-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 30-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2.5 milliliter. On 30-Jun-2022, the patient experienced ACCIDENTAL OVERDOSE (given 2.5 ml of the vaccine for 2nd booster dose). On 01-Jul-2022, the patient experienced CONTUSION (bruising on the right arm), FATIGUE (fatigue) and HEADACHE (headaches , right sided headache). On 05-Jul-2022, the patient experienced NAUSEA (nausea). On 12-Jul-2022, the patient experienced ANXIETY (anxious), RESTLESSNESS (restless), INSOMNIA (not able to sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (normal activities could not be complete), DYSPNOEA (shortness of breath) and MYALGIA (worsening body aches). The patient was treated with ACETAMINOPHEN for Headache, at an unspecified dose and frequency; ALBUTEROL [SALBUTAMOL] for Shortness of breath, at a dose of inhaler and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at a dose of 4 milligram three times a day. At the time of the report, CONTUSION (bruising on the right arm), ANXIETY (anxious), RESTLESSNESS (restless), INSOMNIA (not able to sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (normal activities could not be complete), DYSPNOEA (shortness of breath), MYALGIA (worsening body aches), NAUSEA (nausea) and ACCIDENTAL OVERDOSE (given 2.5 ml of the vaccine for 2nd booster dose) outcome was unknown and FATIGUE (fatigue) and HEADACHE (headaches , right sided headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2022, Activated partial thromboplastin time: 11.4 secs. On 01-Jul-2022, International normalised ratio: 1.2. On 12-Jul-2022, Chest X-ray: blunting of the costophrenic angle which may be due to effusion or scarring..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that HCP did not see any Covid-19 testing on patient's records since 2020. Patient was requested for a CBC (complete blood count) and CMP (Comprehensive metabolic panel), however, the results were unknown.