Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Inappropriate schedule of product administration, No adverse event, SARS-CoV-2 test
Clinical narrative: No adverse event; Dose 1 received on 25-Mar-2021 and Dose 2 received on 30-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 25-Mar-2021 and Dose 2 received on 30-Apr-2021) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A, 017C21A and 004F21A) for COVID-19 prophylaxis.     The patient's past medical history included Paroxysmal supraventricular tachycardia. Concurrent medical conditions included Lobular carcinoma of breast (Lobular carcinoma in situ) and Allergy to antibiotic (Macrodantin). Concomitant products included RALOXIFENE from 01-Dec-2020 to 06-Nov-2022 for Lobular carcinoma of breast.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 25-Mar-2021 and Dose 2 received on 30-Apr-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 25-Mar-2021 and Dose 2 received on 30-Apr-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2022, SARS-CoV-2 test: Positive. On 18-Nov-2022, SARS-CoV-2 test: Negative. On an unknown date, Blood pressure measurement: Blood pressure was always been iow or normal, less than 120/80. and Blood pressure was 135 over something which is much higher than normal.. On an unknown date, Body temperature: 99 Fever 99 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 25-Mar-2021 and Dose 2 received on 30-Apr-2021).    On 03 May 2022, patient took dose 4 of Pfizer / BioNTech vaccine, Batch/Lot No: FM9992, on left arm. Patient had initial symptoms on 27 Oct 2022 and tested positive for COVID-19 on 29 Oct 2022 and began taking Paxlovid on 29 Oct 2022 to 02 Nov 2022. On 07 Nov 2022, the rebound symptoms began including coughing, sneezing and very runny nose. Finally patient tested negative on 18 Nov 2022. Patient reported that she had all the vaccines except the new bivalent one at the time of illness. Patient just got the bivalent vaccine on 02 Dec 2022. She was supposed to get it sooner but cancelled because she had COVID.  Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2022: Follow up received that contains significant information includes case became valid, updated patient demographics, added lab data, updated concomitant product coding, updated suspect product coding, added events and updated narrative.