Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing); "Possible allergic reaction to penicillin" (unspecified if ongoing), notes: suspected allergic reaction, terms of rash, to penicillin. Possible allergic reaction to penicillin; "Lung problem" (unspecified if ongoing), notes: Has the lung problem. It is deteriorating, is not going to get better.; "Pneumonia" (unspecified if ongoing), notes: Was in the hospital, about a week to have IV antibiotics for pneumonia.; "Rash" (unspecified if ongoing), notes: Had a suspected allergic reaction, in terms of rash, to penicillin. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: Allergy test: (2021) Unknown results, notes: Had taken the penicillin allergy test back in 2021; SARS-CoV-2 test: (11Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Tested positive, was feeling actually, better with symptoms. 5 times, she was vaccinated, had booster and everything. Her symptoms are not heavy. When she went and tested positive, because she has bronchiectasis and lung things, this time was not in her lungs but, was all up in her head. Needs to know if there is a penicillin drug involved in any of the 3 pills, of the 2 kinds of pills in the packet. Had a suspected allergic reaction, in terms of rash, to penicillin. Is due Wednesday, to get another penicillin exam at the allergy office, which now, won't be able to do. Clarified that she is wanting to know if there is any penicillin related drug, or whatever, in the Paxlovid pills. Weight: Let's say, between 95 and 100 pounds. Went to an emergency medical office, through. Tested positive for Covid: Was over the weekend. Just finished the second day of packet, of Paxlovid. Has 3 more days ahead of her. The Paxlovid was prescribed that day, she tested positive. Did home test to check on Saturday, reported positive. Went to place that she felt would be reliable and they came up with positive analysis. It was that evening around 6 or 6:30PM that she came home. Does not have any of that information with her, would have to dig it up. They came from different places. Clarified that, regarding the possible allergic reaction to penicillin, she had just come out of the hospital, about a month or, 5 weeks or so, ago, after having a lot of antibiotics. Broke out into a rash and had to take all kinds of steroid things when. Infectious disease doctor was concerned about reaction, to see if it was related to penicillin or not. Has to get another test again, for the penicillin. They are trying to isolate that. Would had been ok with taking it but she had this lung condition. Couldn't take the chance because she has nebulizer twice a day to breathe and, keep lungs healthy. That is why she is questioning if there is any penicillin related product in the Paxlovid. NDC ,LOT, EXP for penicillin and penicillin related drugs they believe caused allergic reaction: Unknown. Clarified that caller was in the hospital around 5 weeks ago, or it might have been 6 weeks. It was recent. Was in the hospital, about a week to have IV antibiotics for pneumonia. Concomitant Products/Medical Conditions: Has the lung problem. It is deteriorating, is not going to get better. Deteriorate, Test results: Had taken the penicillin allergy test back in 2021. Recently, was fairly recent, that they said she was not allergic. Went ahead and took the medications and got the rash. Then, doctor hesitated to give her any penicillin related drug. Now, she has to call their office to let them know she is taking the Paxlovid. Would be helpful to know whether there is any penicillin in the Paxlovid. She asked foe if there would she need to stop taking it or, continue where Caller transferred to USMI to address questions and no further details provided. There was a product complaint to report. Description of Product Complaint: Description of complaint: tested positive for Covid, was vaccinating 5 times, including the booster. Had 5 Covid vaccines, 1 booster, all Pfizer. Product strength and count size dispensed: Unknown. Paxlovid treatment started on 11Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110250 same patent, different drug/event;US-PFIZER INC-202300109928 same patent, different drug/event;