Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; MEDICATION MADE VERY ILL; This spontaneous report received from a patient via Pfizer concerned a 35 year old female. Initial information processed with additional information received on 05-AUG-2022. The patient's height, and weight were not reported. The patient's past medical history included: prednisone allergy, and concurrent conditions included: hypertension, obesity, copd/bronchitis, migraines, herpes simplex virus 2, attention-deficit/hyperactivity disorder, and insomnia, and other pre-existing medical conditions included: 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: 1805022 and expiry: UNKNOWN) dose was not reported, administered 1 in total to the left arm on 08-MAR-2021 08:00 for covid-19 prophylaxis.  Age at time of vaccination 34 years old.  On 19-JUL-2022 22:00, the patient experienced confirmed clinical vaccination failure following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) Patient received non-company suspect vaccine included: tozinameran (Pfizer vaccine) (Dose number in series 2) (batch number: 3203080 and expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered to the left arm on 31-OCT-2021 11:00 for covid-19 prophylaxis. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate, amfetamine sulfate, and eszopiclone.  On 19-JUL-2022 22:00, the patient experienced confirmed covid-19 infection (Dose number in series 2). On 22-JUL-2022, Laboratory data included: COVID-19 virus test Negative. On 24-JUL-2022, Laboratory data included: COVID-19 virus test Positive. On 28-JUL-2022, Laboratory data included: Body temperature 101.5. Patient received non-company suspect drug included: Paxlovid (batch number: Unknown expiry: Unknown, form of admin, route of admin, and were not reported) dose was not reported, administered from 19-JUL-2022 to 24-JUL-2022 for Treatment of COVID-19. Paxlovid made patient very ill immediately upon taking it but completed the full course and was Covid-19 negative after 3 days. However on the last date of taking the treatment, patients Covid-19 test came back positive and patient now starting to feel nasal congestion, headaches, fatigue, brain fog, lethargic, hot/cold feeling inside, dizziness, nausea and cough is returning. Patient had a fever of 101. 5 on the day of reporting, after going 4 days without one and not taking fever reducing medicine. Patient afraid that she have rebound Covid-19 and unsure how to address the symptoms or that patient will not be able to fight this virus on her own. Patient is feeling as sick as patient felt on day one.  The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (Pfizer vaccine) was not applicable, and Paxlovid was not reported. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and medication made very ill was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000245303.; Sender's Comments: V0: 20220808026-covid-19 vaccine ad26.cov2.s-Confirmed 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.