Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Loss of personal independence in daily activities, Malaise, Pain, Periarthritis
Clinical narrative: can't work and type; deep pain; right arm (injection site) was hurting so bad; frozen shoulder from it which goes down to her arm and fingers which is worst at night when she lies down and becomes better when she stands; felt a little lousy; booster; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received 3rd single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: FG3527, expiration date unknown) via an unspecified route of administration in the right arm on 30Oct2021 at age of 64-year-old as booster dose for COVID-19 immunization. Medical history included thyroid cancer, ongoing anxiety, ongoing undiagnosed autoimmune stuff, thyroid disorder, skin condition and connective tissue disorder. Patient previously received BNT162B2, 1st single dose via an unspecified route of administration in the right arm on 28Mar2021 (Lot: ER8733) at age of 63-year-old for COVID-19 immunisation and felt lousy from 29Mar2021 to 29Mar2021; 2nd single dose via an unspecified route of administration in the right arm on 18Apr2021 (Lot: ER8731) at age of 63-year-old for COVID-19 immunisation and felt lousy from 19Apr2021 to 19Apr2021. Concomitant medications included influenza vaccine (FLU VACCINE VII), ongoing escitalopram for anxiety, thyroid replacement for thyroid cancer. Family medical history relevant to the events was none. Relevant tests was none. Patient had the booster dose of the Pfizer COVID-19 vaccine on 30Oct2021 on the right arm. Patient also stated that she had the flu vaccine 2 to 4 weeks prior to the Pfizer COVID-19 vaccine on the same arm. Patient stated that she felt a little lousy the day after her vaccine on 31Oct2021. Patient stated that her right arm (injection site) was hurting so bad on 01Nov2021 and that did not happen initially, but on the second day and was progressively getting worse. Patient stated when she laid down it hurt so bad, she couldn't find a position for her arm. Patient stated that she couldn't get through the day without taking Acetaminophen and Ibuprofen, she couldn't work and type. Patient also stated that she had frozen shoulder on 01Nov2021 from it which went down to her arm and fingers which was worst at night when she lied down and became better when she stood. Patient stated she thought this was a really strong reaction and she never reacts at all to vaccines and never has pain like this. Patient stated a Lidoderm patch didn't even touch the pain. Patient wanted to know the duration of her side effect may be. Caller also stated that there was no redness, heat or swelling, and it was more of deep pain. Caller also wanted to know the characteristic of pain reported as a side effect with the Pfizer COVID-19 vaccine. Events "right arm (injection site) was hurting so bad" and frozen shoulder were reported as serious as other medically important condition. Outcome of "right arm (injection site) was hurting so bad" was not recovered, of "felt a little lousy" was recovered on 31Oct2021, of the other events was unknown. The events didn't require a visit to emergency room or physician office.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events Periarthritis and Vaccination site pain cannot be completely excluded.  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