Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test, Vaccination failure
Clinical narrative: having Covid 27Dec2021/Tested positive 27Dec2021; having Covid 27Dec2021/Tested positive 27Dec2021; sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 06Apr2021 (Lot number: ER8733) at the age of 50 years as dose 2, single and administration date 16Mar2021 (Lot number: EN6207) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: 3 years ago; "Hypothyroidism" (ongoing), notes: diagnosed years ago, she has had changing doses so at least 10 years.; "Hypercholesterolaemia" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); JARDIANCE taken for diabetes mellitus, start date: 2019 (ongoing); LISINOPRIL, start date: 2019 (ongoing); ATORVASTATIN taken for hypocholesterolaemia (ongoing). The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "having Covid 27Dec2021/Tested positive 27Dec2021"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive.  Clinical Course includes that about booster dose of Comirnaty on the 01Feb2022. She just want to report this as she was reading through the website. She knows this is not a fatal issue. She wanted to report what happened after having the 3rd dose. Not sure it is related to having Covid 27Dec2021. She is a healthcare worker so it is mandatory and they said to receive it within 30 days of being infected. Tested positive 27Dec2021 and then got the third dose on 01Feb2022 and then within 12 hours she had fever, chills, and body aches. With the first two, she had nothing, maybe a sore arm. but with this one she had severe chills and last night had body aches. Weird body aches across the lower back and down lower legs and across the hips. She had to take Advil, she had already taken Tylenol, so this could subside so she could sleep. Symptoms are still here today. She feels like crap. She thinks there should be a timeline to get the booster after having Covid. Especially since Pfizer's is the full dose and not the half dose. She really feels like crap and had no reaction to the first two. She could have called out of work today, but as a nurse she keeps chugging along. Also having swelling under armpit too, weirdly, and everyone says that it is lymph nodes and that is fine. Reporter clarified Advil as she took Ibuprofen. She doesn't like to take Ibuprofen because it is not good for the kidneys. she took it in order to go to sleep because the Tylenol didn't work for the body aches. The Tylenol worked for the fever but not the body aches.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of RA information  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