Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive for covid on Friday; she tested positive for covid on Friday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "heart pacemaker" (unspecified if ongoing), notes: Comments: Atrial fibrillation Has a heart pacemaker in place.; "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Thyroidectomy", start date: 2005 (unspecified if ongoing), notes: Thyroidectomy in 2005; "Sleep" (unspecified if ongoing), notes: Indication as Reported by the Primary Source: Sleep. Concomitant medication(s) included: SERTRALINE taken for depression, start date: 2016; WELLBUTRIN taken for depression, anxiety, start date: 2016; VITAMIN D NOS; LEVOTHYROXINE taken for thyroidectomy; ZOLPIDEM taken for sleep disorder, start date: 2012. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Jul2022, outcome "unknown" and all described as "she tested positive for covid on Friday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jul2022) Positive, notes: she tested positive for covid on Friday and then started Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller stated she tested positive for home COVID test on Friday 29Jul2022 and then started Paxlovid noting that she is still on Paxlovid and will finish tomorrow morning. This consumer is the patient who is taking Paxlovid. She reported having stomach cramps and pain. She already called the FDA. She explained that she temporarily stopped taking Carvedilol and Eliquis in response to those events and the events improved. On night of 30Jul2022 about 24 hours after starting Paxlovid she developed severe stomach cramps to the point she thought she was going to have to go to hospital which she is terrified of. She didn't want to discontinue the Paxlovid because it is basically the only thing on the market; so she stopped the Carvedilol and Eliquis instead. Within 24 hours of stopping Carvedilol and Eliquis the pain and stomach cramps stopped dramatically. This is dangerous. She considers these to be moderate to severe side effects. She suffered a lot with those events but thinks she is about 85% recovered from events, still has some soreness/pain. Each blister pack contains 4 nirmatrelvir 150mg tablets each 2 ritonavir 100mg tablets each She is fully vaccinated and boosted. Her and President (name withheld) have that in common. She stopped Simvastatin before starting Paxlovid as directed. She has had no relevant treatment or medical interventions. Had to get a magnifying glass to provide Lot number of Paxlovid which she believed to be 6C0603 or GC0603, clarified to be GC0603 she believed. Product strength and count size dispensed: Each blister pack contains 4 nirmatrelvir 150mg tablets each 2 ritonavir 100mg tablets each, 30 count.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.