Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mental impairment, Myalgia, Nausea, Night sweats, Pain
Clinical narrative: muddled thinking; I had severe total body pain; I had severe total body pain. Muscles bones even skin; I had severe total body pain. Muscles bones even skin; I had severe total body pain. Muscles bones even skin; Headache; Nausea; Feet so sore I could barely walk.; Feet so sore I could barely walk.; Night sweats twice; No appetite; Very tired and sleepy; Very tired and sleepy; Did have a lot of site itching right after shot; This is a spontaneous report from a contactable Nurse (Patient).   A 71-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Ff2589) via an unspecified route of administration, administered in Arm Right on 28Sep2021 as single dose booster for COVID-19 immunisation.  Medical history included p enicillin allergy. The patient received first dose of Concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261) on 02Feb2021 on arm right and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318) on 23Feb2021 on arm right, both at single dose, for COVID-19 immunisation. The patient experienced muddled thinking (medically significant) on 12Oct2021 with outcome of recovered, I had severe total body pain (non-serious) on 12Oct2021 with outcome of recovered , I had severe total body pain. muscles bones even skin (non-serious) on 12Oct2021 with outcome of recovered ,I had severe total body pain. muscles bones even skin (non-serious) on 12Oct2021 with outcome of recovered , I had severe total body pain. muscles bones even skin (non-serious) on 12Oct2021 with outcome of recovered , headache (non-serious) on 12Oct2021 with outcome of recovered , nausea (non-serious) on 12Oct2021 with outcome of recovered , feet so sore i could barely walk. (non-serious) on 12Oct2021 with outcome of recovered, feet so sore I could barely walk. (non-serious) on 12Oct2021 with outcome of recovered, night sweats twice (night sweats) (non-serious) on 12Oct2021 with outcome of recovered , no appetite (non-serious) on 12Oct2021 with outcome of recovered , very tired and sleepy (non-serious) on 12Oct2021 with outcome of recovered , very tired and sleepy (non-serious) on 12Oct2021 with outcome of recovered , did have a lot of site itching right after shot (non-serious) on 12Oct2021 with outcome of recovered.  The patient underwent lab tests and procedures which included Nasal Swab polymerase chain reaction: negative on 15Oct2021 and on 17Oct2021, SARS-CoV-2 antibody test negative on 14Oct2021 and on 16Oct2021.   Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event mental impairment and BNT162B2.  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.