Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Suspected COVID-19
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 71 year old white female. The patient's weight was 77.11 kilograms, and height was 173 centimeters. The patient's concurrent conditions included: interstitial cystitis (Patient was taking hormones for interstitial cystitis and was not taking any other medication other than that). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose were not reported, 1 total administrated on an unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received additional dose of non-company suspect vaccine Pfizer BioNTech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose were not reported, administered on an unspecified date for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). The patient received non-company suspect vaccine Pfizer BioNTech covid-19 vaccine (tozinameran) (dose number in series 3) (form of admin, route of admin, and batch number were not reported) dose were not reported administered on an unspecified date for covid-19 prophylaxis which was a (dose number in series 3). On 29-AUG-2022, the patient got sick and had suspected COVID-19 (dose number in series 3) for which patient received non-company suspect drug Paxlovid (route of administration were not reported, batch number: GD8756 and Expiry date: MAR-2023) dose and frequency were not reported, administered on 31-AUG-2022 to 02-SEP-2022. On 31-AUG-2022, the patient was not sure about all this happened because of Paxlovid as, all this was started after taking Paxlovid. The patient had blood pressure shot up to 166 over a 100. Patient took Paxlovid three times to make sure, it was right and then patient passed out. Patient called the doctor who suggested patient to immediately stop Paxlovid. Patient was needed to come to urgent care. The patients blood pressure was then better and not 166 but, it did not come back down to normal and patient stopped Paxlovid on 02-SEP-2022 and started with couple of Advil. On an unspecified date in 2022, patient had extreme nausea and all over was feeling bad and well-being was gone. Patient reported that, without your boosters (Pfizer COVID-19 Vaccine), patient would have died. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and with Paxlovid was drug discontinued on 02-SEP-2022. The patient was recovering from blood pressure increased, and the outcome of passed out, extreme nausea, all over feeling bad and well-being was gone, suspected COVID-19 and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220928612- covid-19 vaccine ad26.cov2.s-passed out. The event(s) has an unknown/unclear 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: CONMEDS-OTHER SUSPECT DRUGS (Paxlovid) Therefore, this event(s) is considered not related.