Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: got the Pfizer Covid Vaccines/got Covid; got the Pfizer Covid Vaccines/got Covid; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 67-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EL9267), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "got the Pfizer Covid Vaccines/got Covid". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Caller stated that she was calling about the Pfizer Product: Paxlovid. Stated that she and her husband both have Covid and the doctor put them on Paxlovid. Caller stated they went to the pharmacy and picked up their two boxes. Caller stated that the two boxes have two different directions. One of them says to use as directed on the package. The other one says to take 2 by mouth twice a day, then one by mouth twice a day for 5 days. Caller stated that she was a Registered Nurse and she looked at the pamphlet and it said to take two of the 150 Nirmatrelvir and one of the 100 Ritonavir in the morning and at night. Caller stated that was what her and her husband did last night. Caller stated that she called the pharmacist and told her she did not understand the directions. The pharmacist said to take one 150 tablet and one 100 tablet in the morning and at night. Caller stated that was the way the medication was packaged. Caller stated then the pharmacist called her back and stated that she needed to take two of the 150 tablets and one of the 100 tablets. Caller stated that she wants to see if her and her husband are doing the right thing. Caller stated that the Paxlovid packaging and pamphlet was confusing. Caller also mentioned that her and her husband both got the Pfizer Covid Vaccines and the booster doses. Caller stated that they were just about to get their second booster when they got Covid. Caller mentioned they had 500 dollar IV therapy yesterday also. Caller stated that she started having Covid symptoms on Tuesday, 17May2022. She took a test on Wednesday, and it was positive. Caller stated that since her husband has the same symptoms they assumed him to be Covid positive also, although he took no test. Caller stated that her husband started Paxlovid last night. Paxlovid: Caller stated that the Expiry Date and Lot Numbers are the same on both her and her husband's boxes of Paxlovid. NDC numbers unknown. Caller stated that both her and her husband started this medication last night. Pfizer Covid Vaccines: Caller stated that the dates and Lot Numbers for her and her husbands doses of the Pfizer Covid Vaccines are the same. Second Dose of the Pfizer Covid Vaccine: Received by the patient on 11Mar2021; Lot Number: Caller states that it looks like it is either E16205 or EL6205. Caller states that they both had IV Therapy yesterday that really helped them. Stated it was called a Covid Cocktail and consisted of Lactated Ringers, Vitamin C, Glucagon, Vitamin B12, and she does not know what else.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.