Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Dehydration, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; DEHYDRATION ALL THE TIME; HIGH BLOOD SUGAR LEVEL; LOSS WEIGHT; INCREASED BLOOD PRESSURE TO 181/106; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient by other manufacturer (Pfizer Inc.) concerned a 59 year old female. Initial information was processed along with the additional information received on 10-MAY-2023. The patient's height, and weight were not reported. The patient's past medical history included: removal of spleen, and concurrent conditions included: pancreas cancer, tumor, diabetes, high blood pressure, interstitial cystitis, liver lesion, fatty liver disease, pulmonary nodule, hypothyroidism, elevated ferritin, obstructive sleep apnea, migraine, and allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 16-MAR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 10-NOV-2021 for covid-19 prophylaxis. Concomitant medication included levothyroxine. The batch number was not reported and has been requested. Age at time of vaccination 6 decade old. The patient also received non-company suspect Moderna covid-19 vaccine, (elasomeran), (Dose number in series 3), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 13-SEP-2022 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). On 15-MAR-2023, the patient experienced confirmed covid-19 infection (Dose number in series 3) and had confirmed clinical vaccination failure (Dose number in series 2). Laboratory data included: COVID-19 virus test Positive. After that patient had taken Non-company suspect drugs Paxlovid, (nirmatrelvir/ritonavir), (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 15-MAR-2023 to 20-MAR-2023 for covid-19 treatment. Patient also had covid-19 rebound infection on 30-MAR-2023. After taking that treatment medication (Paxlovid), patient experienced Dehydration all the time, severe headache, high blood sugar level reach 417, increased blood pressure to 181/106, changes in taste and for the past one month or so feeling unwell, fatigue, weakness, easily get tired, short of breath and recently loss weight and drastic muscle fat loss (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of dehydration all the time, high blood sugar level, increased blood pressure to 181/106, loss weight, confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230520556-increased blood pressure to 181/106. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration. 20230520556-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.