Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 40 year old female. Initial information was processed along with the additional information received on 13-JAN-2023. The patient's height, and weight were not reported. The patient's past medical history included: bronchitis, and walking pneumonia, and concurrent conditions included: Cipro and fluoroquinolone ant biotics sulfa medication allergy, hypermobile spectrum disorder (just missed Ehlers Danlos), suspected mast cell activation disorder, and asthma, and other pre-existing medical conditions included: The patient was not pregnant at time of vaccination. The patient received 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, 1 total administered on 03-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 38 years old.  The patient received additional non-company suspect vaccine included: Spikevax (elasomeran) (Dose number in series 2) (form of admin, route of admin, and were not reported, batch number: 076C21A expiry: UNKNOWN) dose was not reported, administered on 23-OCT-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). Concomitant medications included Zyrtec (cetirizine hydrochloride), Pepcid(famotidine), Singulair (montelukast sodium), and naltrexone.  On 23-DEC-2022, patient had COVID 19 symptoms (confirmed covid-19 infection) (dose number in series 2) which resulted to confirmed clinical vaccination failure (Dose number in series 1). Patient started Paxlovid (form of admin, route of admin, and were not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered from 24-DEC-2022 to 28-DEC-2022) within 24 hours of symptoms for COVID 19 treatment. Patient already had a nasty cold for several weeks when she contracted COVID. Patient had a hard time getting rid of colds. On 29-DEC-2022, the day after completing Paxlovid, she felt better. No fever, just a bit of a cough. Patient took home Covid-19 test which took the full 15 minutes to barely turn the faintest line possible as positive (it was a shadow). On 02-JAN-2023, at night, 5 days after completing Paxlovid, patient realized that she wasn't feeling well. Patient had worsening of COVID-19 symptoms. She was feeling exhausted, her nose was running, and was coughing more. She took another home test, which popped positive right away (didn't take any time at all) and was a dark line after 15 minutes.  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with paxlovid was drug withdrawn. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000266854.; Sender's Comments: V0: 20230122587-confirmed clinical vaccination failure. The event 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.