Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: COVID-19, COVID-19 immunisation, Ear pain, Paraesthesia, SARS-CoV-2 test
Clinical narrative: EAR PAIN; MUSCLE TINGLING; 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 66 year old female. Initial information was processed along with additional information on 21-FEB-2023. The patient's height, and weight were not reported. The patient's past medical history included: ruptured spleen (ruptured spleen due to fall), fall, and splenectomy (total), and concurrent conditions included: drug allergy (Thimerosal reaction), and immunocompromised, and other pre-existing medical conditions included: The patient not had other conditions or medication. The patient was not pregnant at the 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: 1805025 expiry: UNKNOWN) dose was not reported, 1 total, administered at right arm on 05-MAR-2021 10:30 for covid-19 prophylaxis. Age at time of vaccination 64 years old. No concomitant medications were reported. The patient also received moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin and route of admin was not reported, batch number: 939904, expiry: Unknown) dose was not reported, administered at right arm on 04-NOV-2021 for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with moderna covid-19 vaccine (elasomeran) (Dose number in series 2).  The patient also received moderna covid-19 vaccine (elasomeran) (Dose number in series 3) (form of admin and route of admin was not reported, batch number: 001M21A, expiry: Unknown) dose was not reported, administered at right arm on 22-APR-2022 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). On 01-FEB-2023, Laboratory data included: COVID-19 virus test Positive (lateral flow test), the patient had covid-19 (confirmed covid-19 infection) (Dose number in series 3) and received non company suspect drug paxlovid (nirmatrelvir/ritonavir) (form of admin and route of admin was not reported, batch number: GF4083 expiry: Unknown) dose and frequency were not reported from 01-FEB-2023 to 05-FEB-2023 for covid-19 treatment. On an unspecified date, the patient had chills, sore throat, headache, runny nose, sneezing, watery eyes, diarrhea and poor appetite returned after feeling well for about 5 days (confirmed covid-19 infection) (Dose number in series 3). The patient also had muscle tingling and ear pain (Dose number in series 3). On 12-FEB-2023, Laboratory data included: COVID-19 virus test Positive (11 days after first positive lateral flow test) which leads to confirmed clinical vaccination failure (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and elasomeran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The outcome of the confirmed covid-19 infection, confirmed clinical vaccination failure, revaccination with different covid-19 vaccine, muscle tingling and ear pain was not reported. This report was serious (Other Medically Important Condition). This case was associated with a product quality complaint: 90000272070.; Sender's Comments: V0: 20230244175-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.