Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Polymerase chain reaction, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: She is just a little tired; Her nose is drippy; She has a little drainage into her throat; tested positive for Omicron/ she gets the booster, and gets COVID; tested positive for Omicron/ she gets the booster, and gets COVID; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 25Sep2021 (Lot number: FF2588) at the age of 66 years as dose 3 (booster), single, administration date 12Feb2021 (Lot number: EL9269) as dose 1, single and administration date 05Mar2021 (Lot number: EN6205) as dose 2, single for covid-19 immunisation. Relevant medical history included: "she fell down" (unspecified if ongoing); "broke her toes" (unspecified if ongoing); "concussion" (unspecified if ongoing); "She has lost 80 lbs already" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shot (She received a flu shot earlier in Sep2021 it was 6 weeks before her booster.), administration date: Sep2021, for immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "tested positive for Omicron/ she gets the booster, and gets COVID"; FATIGUE (non-serious), outcome "recovering", described as "She is just a little tired"; RHINORRHOEA (non-serious), outcome "recovering", described as "Her nose is drippy"; UPPER-AIRWAY COUGH SYNDROME (non-serious), outcome "unknown", described as "She has a little drainage into her throat". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (30Dec2021) positive, notes: tested positive for Omicron; sars-cov-2 test: (31Dec2021) positive.  Clinical course: The patient tested positive for Omicron. She already took the COVID booster shot. The patient is doing okay. It has been two years, and she has never got it, but then she gets the booster, and gets COVID. She has been fine with the vaccine, and the Omicron comes and bam she gets it. She is okay. She is alright. She is just a little tired. Her nose is drippy. She has a little drainage into her throat. She is fine especially compared to what she has seen. She has had no shortness of breath. She believes in the vaccine. She has had both Pfizer COVID vaccines and the COVID booster. She is ready for another whenever she it told to get it. She used to be a computer consultant, and then she went to become a nurse at 54 years old. Then, she went to get her RN, and two weeks before the end, she fell down and broke her toes and had a concussion. The program wouldn't give her more time. They were real bastards. She is still going back for her Registered Nurse. She is trying to get down to 135 lbs. She has been eating a new way called Keto. She has lost 80 lbs already. It is really easy since she has been about to figure out what foods to eat. She was calling today because she is trying to obtain COVID 19 test kits. She knows she is COVID positive so she is having to stay in the upstairs level of her sister's home. Everyone in that house is pretty immunocompromised. Her brother has COPD and is on oxygen. Her sister fell and has a broken eye socket and wrist. She has a plate and screws in her knee. Her niece has epilepsy. The patient cannot find a kit, and she needs one. She needs to protect her family. She tested positive on a rapid test on 31Dec2021. Then, she had a PCR test on the 30, but her results came back two days later. She had another confirming positive PCR test. Her first dose was on 12Feb2021 with lot number EL9269. Her second dose was on 05Mar2021 with lot number EN6205. Her booster dose was on 25Sep2021 with lot number FF2588. She just wanted to report she did test positive. She received a flu shot earlier in Sep2021 it was 6 weeks before her booster. She got the booster in her left arm. She is not upset with Pfizer. It is okay. She knows the Omicron is very variant.; Sender's Comments: Based on the information provided, a possible causal association between the reported events vaccination failure, Covid-19, fatigue, rhinorrhea, upper airway cough syndrome and the suspect BNT162B2 is possible.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.