Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Oxygen saturation, Pain in extremity, SARS-CoV-2 test
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 58 year old female of unspecified ethnicity  Initial information was processed along with the additional information received on 27-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, high blood pressure, and high cholesterol, and other pre-existing medical conditions included: patient has no known allergies. The patient was previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered 1 in total to the arm on 02-APR-2021 for prophylactic vaccination. Age at time of vaccination 57 years old. Per report, patient stated that she might vaccinated on left arm. On AUG-2021 patient got covid-19. Patient was coughing. Patient paid to get a false negative test at first. Then was giving free testing and patient tested positive (confirmed covid-19 infection). Since patient contracted Covid more than 4 weeks after initial vaccination (confirmed clinical vaccination failure). Patients entire family got covid-19 too, so patient panicked and had trouble breathing, so she went to the emergency room. Patients oxygen level was fine, chest X-Ray was fine. Patient did lose smell and taste for one day. After quarantine, patient got jiggly legs (had trouble walking for a day) and memory loss (Patient says she was forgetting a few things). Patient felt depressed and lonely following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Laboratory data included: COVID-19 virus test Positive, COVID-19 virus test false negative, Chest X-ray fine, and Oxygen saturation fine. The patient received second dose of  covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered 1 in total to the arm patient thinks left arm on 03-NOV-2021 for prophylactic vaccination. Age at time of vaccination 58 years old. No concomitant medications were reported.  On 03-NOV-2021, the patient experienced sore arm following first night of vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 04-NOV-2021. This report was non-serious. This report was associated with product quality complaint: 90000237316 The suspected product quality complaint has been confirmed to be voided, this record describes an adverse reactions (sore arm) to the product subsequently administration of the second booster dose. There is no product quality issue described and the case does not meet the definition for a product quality complaint (PQC) or explicitly allege a potency issue. Covid infection contracted in AUG-2021 after primary vaccine received on 02-APR-2021 was captured under product quality complaint: 90000237315. There was no covid infection reported after the booster dose received on 03-NOV-2021. This record will be sent for void approval as no PQC based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20211229616.