Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 66 year elderly female. Initial information was processed along with additional on 17-MAY-2022. The patient's height, and weight were not reported. The patient's past medical history included: headaches and abnormal EEG (electroencephalogram), and concurrent conditions included: hypothyroidism, lichen sclerosis, drug allergy (Clindamycin, ampicillin and cephalosporins) and food allergy (raw onions), and other pre-existing medical conditions included: The patient was a heath care professional (nurse). The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: unknown) dose was not reported, 1 total administered on 30-MAR-2021 for prophylactic vaccination. Age at time of vaccination 65 years old. Concomitant medications included benzonatate, estradiol, levothyroxine sodium, prednisone, and salbutamol. On 08-MAY-2022 patient had vaccination failure (dose number in series 1). The patient received additional dose of Spikevax (Moderna) (elasomeran) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 939903 and expiry: unknown) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination.  On 30-APR-2022, patient received Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: FR7229 and expiry: unknown) dose not reported for treatment of COVID-19. The patient completed the course of 5 days of Paxlovid treatment and discontinued on 04-MAY-2022.  After 5 days, on 08-MAY-2022, the patient's symptoms of sore throat, sinus pain and nasal congestion returned (it was not clearly reported when the patient had experienced the symptoms previously) and she tested positive for Covid-19 rapid test (dose number in series 2). The patient did not receive any treatment and was not hospitalized. Laboratory data included: COVID-19 rapid POC (point of care) test (NR: not provided) positive. Laboratory data (dates unspecified) included: EEG (NR: not provided) abnormal (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The product was associated with a product quality complaint: 90000231592.; Sender's Comments: V0: 20220530412-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.