Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with covid on 01Jan2024/ covid test positive; diagnosed with covid on 01Jan2024/ covid test positive; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 52-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9694) and on 31Aug2023 as dose 6 (booster), single (Lot number: GK0928) at the age of 52 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, 30 ug single (Lot number: EW0150), on 25Apr2021 as dose 2, single (Lot number: EW0171), on 03Nov2021 as dose 3 (booster), single (Lot number: FF2596) and on 27Apr2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation. The patient's relevant medical history included: high blood pressure began around 2004 and after her pregnancy she had gestational diabetes with her pregnancy and ended up with the high blood pressure and diabetes after her pregnancy; Heart murmur happened after they removed her thyroid and she thinks that was 2018; Fatty liver had since she was age 28; her sugar numbers are really high" (unspecified if ongoing). Concomitant medication(s) included: BASAGLAR taken for diabetes mellitus (ongoing), regarding her insulin and that she noticed her sugar numbers were high at like 300 and are hovering at 250 and 300, caller clarified that the insulin was just the only thing she did not stop and it was the Basaglar manufactured and states she does not have that with her at this time; STEGLATRO taken for diabetes mellitus management, clarified this is a pill to help lower the sugar but it puts stress on the kidneys and she is taking it right now but clarified just while taking Paxlovid it is stopped and it is manufactured by Merck; METFORMIN, stated she also takes Metformin which is manufactured by Merck also. The Metformin is a tablet and is a 1000mg pill that is taken twice a day but it has a side effect that is gastrointestinal side effect and is not good to take if sick; she does experience the gastrointestinal side effect and if she took it, it would make her fill sicker like right now she has the covid and has gastrointestinal complications from covid and if she were to take the Metformin she thinks she would experience heavier symptoms of that. For the Gastrointestinal side effect, states with the Steglatro it is not so much regarding GI complications but the Stegaltro just basically takes the sugar out of the blood through the urine and it increases regarding that it makes her go to bathroom all the time and that has happened with her urine and urinating constantly or whether it is side effects from covid but it is urgency to urinate; LOSARTAN POTASSIUM, the lot is 0000063232, expiry date 14Mar2026, NDC is 4354736209. Regarding the statement that she sometimes feels like her medications are not working and she is scared maybe they are giving her sugar pills clarified it's like she does not see a change sometimes in her blood pressure for the medication Losartan and that comment was in regards to the Losartan product; states she does not take anything manufactured outside the country and she does not know what is happening; LEVOTHYROXINE, began that when they removed her thyroid in 2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2024, outcome "recovering" and all described as "diagnosed with covid on 01Jan2024/ covid test positive". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. Clinical details: patient was currently taking Paxlovid and says that she was told to stop taking all of her medicines and was calling today because her insulin is not doing it for her diabetes and her numbers are really high and she wanted to know if there were any drug interactions with Steglatro and Metformin. She went in early September or the end of August and went to go get the vaccine and the new one had not come out yet and instead of giving her the new one they gave her a 2nd bivalent vaccine and because they gave her that and she could not get the latest vaccine she thinks that is why she got covid. She is still taking the Paxlovid and asks if it should still be good due to the expiry date of 20Dec2023. The Paxlovid has the SIN or SN number of 259809422993 and asks if it is still good even though it is expired and she did not know it was expired as she did not look at it but got the Paxlovid in the first of the year and she is feeling better so she guesses it is working and began taking it 01Jan2024; Paxlovid has the lot number of GK0610 and NDC 00691085-30. The Paxlovid is three tablets by mouth twice a day for 5 days and it says Paxlovid 150 times two-100mg PKEUA on the package and says 300mg 100mg dose packet morning and night; she is going to finish the Paxlovid because if she is dead it would not matter if she has diabetes so first thing is to fix this covid thing. When she got the Paxlovid medicine she also read up on it and is not having side effects and still retained taste and smell and is not having or showing signs of liver damage. She had to stop all her medication like Losartan potassium tablets and they are probably manufactured outside the country and states she can't find the manufacturer on the bottle. She sometimes feels like her medications are not working and she is scared maybe they are giving her sugar pills and she has serious issues with that; states she is getting tired. Her main question is that they gave her an expired lot of medicine for the Paxlovid and asks is it still working as she is such a high risk person.