Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Drug specific antibody, Headache, Nervousness, Product dose omission issue
Clinical narrative: Outside 37 day dosing interval/05Mar2021 and still has not gotten the second dose/Patient has not got second dose yet/ has not received the second dose she is 88 days out; headache; She was feeling shaky; Diarrhoea; Sore arm; nervous; pain at injection site; This case was initially received via the Regulatory Authority (Reference number: 128020   ) on 09-Mar-2021. The most recent information was received on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (She was feeling shaky), DIARRHEA (Diarrhea), VACCINATION SITE PAIN (Sore arm), NERVOUSNESS (nervous) and PRODUCT DOSE OMISSION ISSUE (Outside 37 day dosing interval/05Mar2021 and still has not gotten the second dose/Patient has not got second dose yet/ has not received the second dose she is 88 days out) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety. Concurrent medical conditions included Atrial fibrillation. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, DRONEDARONE HYDROCHLORIDE (MULTAQ), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D NOS, ROSUVASTATIN and ALPRAZOLAM for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm), NERVOUSNESS (nervous) and VACCINATION SITE PAIN (pain at injection site). On 20-Mar-2021, the patient experienced TREMOR (She was feeling shaky), DIARRHEA (Diarrhea) and HEADACHE (headache). On 01-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Outside 37 day dosing interval/05Mar2021 and still has not gotten the second dose/Patient has not got second dose yet/ has not received the second dose she is 88 days out). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 07-Mar-2021, VACCINATION SITE PAIN (pain at injection site) had resolved. On 08-Mar-2021, VACCINATION SITE PAIN (Sore arm) and NERVOUSNESS (nervous) had resolved. On 23-Mar-2021, TREMOR (She was feeling shaky), DIARRHEA (Diarrhea) and HEADACHE (headache) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Outside 37 day dosing interval/05Mar2021 and still has not gotten the second dose/Patient has not got second dose yet/ has not received the second dose she is 88 days out) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Drug specific antibody: 68 (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Recieved first dose of the Modena vaccine on 05Mar2021 and still has not gotten the second dose. Patient states that in July2021 they had their antibodies tested and had a positive result of 68. Patient took CENTRUM JUNIOR as concomitant product.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non significant follow up On 09-Aug-2021: Follow up information was received wherein in vaccine start date was changed from 05 Mar 2021 to 06 Mar 2021 and the outcome for the event missed dose was updated.