Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiolipin antibody, Cardiolipin antibody positive, Immunisation, Pain in extremity
Clinical narrative: Booster; Sore arm; Cardiolipin antibodies went up after the COVID booster higher than normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A 80-year-old female patient received bnt162b2 (BNT162B2), administration date 22Sep2021 (Batch/Lot number: unknown) at the age of 80 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Positive cardiolipin antibodies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single), administration date: 08Feb2021, when the patient was 79 years old, for COVID-19 Immunisation, reaction(s): "Sore arm"; Bnt162b2 (Dose 2, Single), administration date: 08Feb2021, when the patient was 79 years old, reaction(s): "At that time her Cardiolipin level was about 40"; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; CARDIOLIPIN ANTIBODY POSITIVE (non-serious) with onset 2021, outcome "unknown", described as "Cardiolipin antibodies went up after the COVID booster higher than normal"; IMMUNISATION (non-serious) with onset 22Sep2021, outcome "unknown", described as "Booster". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She has a history of positive cardiolipin antibodies. Reason for no lot number of COVID vaccine was caller unwilling to complete the report. Expiry Date of COVID vaccine was not provided. Other products, patient history and investigation assessment were not provided. Additional Context: She was calling to report that her cardiolipin antibodies went up after the COVID booster higher than normal. She was taking blood test after the second dose, and booster dose. After the booster dose, her cardiolipin went up high. She also mentioned a sore arm. She did not really say when she got the sore arm. She said it was a minimal condition. This did not occur after the second COVID dose. Her second dose was 08Feb2021. She states that she got her cardiolipin antibodies tested on 05Mar2021 and she had a 40 result. At that time her Cardiolipin level was about 40, AbigM. Then, on 22Sep2021 she had her booster dose. After the booster dose, she got tested again on 27Oct2021 and her cardiolipin IgM levels 102.1 which was quite high. Normally her cardiolipin was antibody positive with IgM, and somewhat with IgA also. It was a little higher which was concerning to her. She knows cardiolipins can be a problem with blood clotting. She has to leave at a quarter to two. She does not have time to do this. Her physician told her not to worry. Reporter seriousness for elevated cardiolipin antibodies and sore arm was unspecified.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.