Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Laboratory test, Off label use, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a patient concerned a 79 year old female of an unspecified race and ethnic origin. The patient's weight was 180 (unspecified) and height was 167.64 centimeters. The patient's past medical history included: cancer (3 time cancer (unspecified) survivor), and surgically removed colon, and concurrent conditions included: allergic to polyethylene glycol (allergic to Polyethylene glycol 100 and Polysorbate 80), congestive heart failure, immunocompromised, breast cancer, lymphoma, HTN (Hypertension), squamous cell carcinoma (Mets to colon), penicillin allergy, drug allergy (Neupogen (Filgrastim)), severe degenerative osteoarthritis, no alcohol use, and no smoking, and other pre-existing medical conditions included: Patient had some other issues. The patient had no history of drug abuse, no illness at the time of vaccination, no past history of similar events, no adverse events after any previous vaccination(s), no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days with cause, no family history of any disease (relevant to vaccination) or allergy. The patient was not a pregnant at the time of vaccination and not currently breastfeeding. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series :1) (suspension for injection, intramuscular, batch number: 1805029 and expiry: Unknown) dose was not reported, 1 in total, dose 1 administered in arm (unspecified) on 19-MAR-2021 for covid-19 prophylaxis. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series :1). The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series :2) (suspension for injection, intramuscular, batch number: 1882809 and expiry: Unknown) dose was not reported, 1 in total, dose 1 administered in arm (unspecified) on 10-NOV-2021 for covid-19 prophylaxis. On JAN-2022  two months after following vaccination with first booster of covid-19 vaccine ad26.cov2.s, the patient contracted Covid which was suspected covid-19 infection (Dose number in series :2). It was a severe case but patient was able to get the monoclonal antibody infusion. Patient felt that the vaccine offered some protection from more severe illness and the earlier forms of the Covid. The outcome of suspected covid-19 infection (Dose number in series :2) not reported. The patient additionally received 3rd dose of covid-19 vaccine ad26.cov2.s (Dose number in series :3) (suspension for injection, intramuscular, batch number: 213021A and expiry: Unknown) dose was not reported, 1 in total, administered in right arm on 23-MAR-2022 for covid-19 prophylaxis which was associated with Off label use (off label dosing frequency) (Dose number in series :3). Age at time of vaccination 79 years old. Concomitant medications included palbociclib for cancer, and chemotherapy, carvedilol for congestive heart failure, crocus sativus for memory focus enhancement, gabapentin for neuropathy, lorazepam for sleep, acetylsalicylic acid for stroke prevention, and Exemestane. On 13-MAY-2022, the patient experienced ache all over for four weeks, clod like headache and foggy brain. On the same day the patient tested positive for covid-19 which was confirmed covid-19 infection and confirmed clinical vaccination failure (Dose number in series :3). Laboratory data included: COVID-19 virus test Positive. On 16-MAY-2022, the patient again confirmed covid-19 infection by antigen test. Laboratory data (dates unspecified) included: Lab test Diagnosed with CHF (congestive heart failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and foggy brain on 10-JUN-2022, and the outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20220664235.