Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned an 84 year old female with unspecified race and ethnic origin. Initial information was processed along with the additional information received on 14-SEP-2022. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 4381507) dose was not reported, 1 total administrated on left arm, therapy start date was not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with doses of covid-19 vaccine (dose number in series 1). The patient was previously treated with 2 dose of elasomeran (moderna)  (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 023420A;405A21A) dose was not reported, on 18-FEB-2021 and 18-MAR-2021  on left arm for covid-19 prophylaxis It was unknown whether patient had any adverse events following vaccination with two doses of elasomeran (moderna) (dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 30-OCT-2021  on left arm for covid-19 prophylaxis. The product was associated with off label use (off label dosing frequency) (dose number in series 3). Age at time of vaccination 84 years old. Concomitant medications included ascorbic acid/betacarotene/biotin/calcium carbonate/calcium pantothenate/chromic chloride/colecalciferol/copper sulfate/cyanocobalamin/folic acid/ginkgo biloba/magnesium oxide/magnesium stearate/manganese sulfate/nicotinamide/phytomenadione/potassium iodide/pyridoxine hydrochloride/retinol acetate/riboflavin/sodium molybdate/sodium selenate/thiamine mononitrate/tocopheryl acetate/zinc oxide for general health, curcuma longa rhizome for general health, and ascorbic acid/cupric oxide/dl-alpha tocopheryl acetate/xantofyl/zeaxanthin/zinc oxide for macular degeneration.  The patient received non-company suspect vaccine tozinameran (pfizer) (dose number in series 4) (intramuscular, batch number: PM9092, form of admin was not reported) dose was not reported, administered on 03-APR-2022 on left arm for covid-19 prophylaxis.  On 03-APR-2022, the patient experienced revaccination with different covid-19 vaccine. On 09-AUG-2022, the patient had done COVID-19 virus test which was positive also had fever which resulted in confirmed covid-19 infection. On 10-AUG-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported administered. On 14-AUG-2022, Laboratory data included: COVID-19 virus test Negative. On 20-AUG-2022 at 18:00, the patient again had done COVID-19 virus test which was positive and had covid-19 infection again and had treatment medications included: vitamin C and echinacea purpurea. On 26-AUG-2022, Laboratory data included: COVID-19 virus test Negative. The break through covid-19 that was milder than the original and lasted a week  (dose number in series 4). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on 26-AUG-2022, and the outcome of off label dosing frequency and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000251480; Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.