Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: Tested Positive for Covid after receiving 4 Doses of the Covid Vaccine; very very tired and congested/they found out it was Covid; Tested Positive for Covid after receiving 4 Doses of the Covid Vaccine; very very tired and congested/they found out it was Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 99-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), 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: "Shellfish" (unspecified if on-going); "Raspberrie" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "allergic to codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested Positive for Covid after receiving 4 Doses of the Covid Vaccine; very very tired and congested/they found out it was Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested Positive for Covid after receiving 4 Doses of the Covid Vaccine; Positive, notes: they started the patient on Paxlovid and tested her for Covid again and it was positive; Weight: 160-165 lbs. Therapeutic measures were taken as a result of drug ineffective, covid-19. Proprietary medicinal product name: PAXLOVID. Active Drug substance names: nirmatrelvir tablets; ritonavir tablets. The caller has received four doses of the covid 19 vaccine, the patient took 3 doses of Paxlovid, developed a welt over her eyebrow and rash in the middle of her forehead. The caller reports the patient stopped taking the medication. The caller reports that she knows the two booster doses of the covid 19 vaccine the patient received were Moderna; caller says the first two doses of the vaccine the patient received were different and she does not have the LOT numbers at time of call. The caller reports the patient used Benadryl cream which helped the welt/rash clear up a "little bit". The caller is asking if the there is an-other medication that may be used instead of Paxlovid? The caller notes she is aware another person is using a Z-pack. Caller states her mother had all of her Covid Shots, the 2 regular and the 2 Boosters, but she still ended up with Covid. Caller states she just thought her mom was very very tired and congested and she thought it was asthma, but after her sister took the patient to Urgent Care they found out it was Covid. Caller states the Urgent Care told the patient to see her Doctor, but the Doctor is out of town for 2 weeks, so they took the patient to the (health department name withheld) and they started the patient on Paxlovid and tested her for Covid again and it was positive. Caller states the patient started the Paxlovid, the 3 pills at night, and then she took the 3 pills for the day time, and then she took the next 3 pills for night and then she had a huge welt over her eye brow in the shape of her eye brow and another welt above that and a rash in the middle of her forehead. Caller states they were advised by a Pharmacist to stop taking the medication. Caller states her brother used to be an EMT (emergency medical technician), and he advised the patient to stop taking the medication as well. Caller states the patient is doing a little better. Caller states they spoke to another person who also has Covid and that person told them their doctor gave them a Z-pack to take. Caller asking if there is another medication the patient can take, since the patient had a reaction to the Paxlovid?. Treatment: Benadryl Cream. Caller states she hasn't checked on the patient this morning because the patient is still sleeping, but it was improving last night. Caller states the patient discontinued the medication, which also concerned her because it said don't stop without consulting a provider.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.