Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Joint swelling, Loss of personal independence in daily activities, Off label use, Peripheral swelling
Clinical narrative: felt a lot of pain in her joints/Couldn't move joints without pain/joints are still somewhat puffy and sore; Hands swelled really bad; She couldn't walk; joints were aching and swelling; I couldn't use my hands whatsoever for anything, I couldn't even grab a bottle or take the cap off of anything; she needed helped to go to the bathroom and get up; felt like she had a temperature, but she did not have a temperature; 5th dose; 5th dose; cellulitis on her right anterior calf (right leg); This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (ongoing), notes: probably 30 years; "knee replacement" (unspecified if ongoing); "4 back surgeries" (unspecified if ongoing); "neck surgery" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot number: unknown), administration date: 03Feb2021, when the patient was 71-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Lot number: unknown), administration date: 24Feb2021, when the patient was 71-year-old, for Covid-19 immunization; BNT162b2 (Dose 3, Lot number: unknown), administration date: 15Oct2021, when the patient was 72-year-old, for Covid-19 immunization; BNT162b2 (Dose 4, Lot Number: FP7135), administration date: 21Jul2022, when the patient was 73-year-old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 30Sep2022, outcome "unknown" and all described as "5th dose"; CELLULITIS (medically significant) with onset 30Sep2022, outcome "unknown", described as "cellulitis on her right anterior calf (right leg)"; PYREXIA (non-serious) with onset 02Oct2022, outcome "unknown", described as "felt like she had a temperature, but she did not have a temperature"; ARTHRALGIA (medically significant), outcome "not recovered", described as "felt a lot of pain in her joints/Couldn't move joints without pain/joints are still somewhat puffy and sore"; PERIPHERAL SWELLING (medically significant), outcome "recovering", described as "Hands swelled really bad"; GAIT INABILITY (non-serious), outcome "unknown", described as "She couldn't walk"; JOINT SWELLING (non-serious), outcome "unknown", described as "joints were aching and swelling"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "I couldn't use my hands whatsoever for anything, I couldn't even grab a bottle or take the cap off of anything"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "she needed helped to go to the bathroom and get up". The events "felt a lot of pain in her joints/couldn't move joints without pain/joints are still somewhat puffy and sore" and "hands swelled really bad" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: (02Oct2022) felt like she had a temperature. Therapeutic measures were taken as a result of cellulitis, arthralgia, peripheral swelling.  Clinical course: It was reported that patient has a history of arthritis. After the vaccine her joints were aching and swelling. She asks if this is normal have other people reported it. Is this a typical side effect. Patient provided that when she went to her Doctor on Friday (30Sep2022), the day she got her shot, Dr put her on Augmentin for cellulitis on her right anterior calf (right leg) that was diagnosed there. She didn't start taking the antibiotic until later that evening. The patient has had arthritis for 30 years, however after getting the vaccine, she felt a lot of pain in her joints: "I couldn't walk, I couldn't use my hands whatsoever for anything, I couldn't even grab a bottle or take the cap off of anything. I was totally dependent on my husband for two days. I would consider it severe pain, on the scale 1 to 10 it was a ten. It was a sharp, throbbing (inaudible) pain. Today it's not so bad but I can't I touch the thumb area because it feels like a bad bruise." Furthermore, patient states that she got this shot last Friday. On Saturday she was okay. She woke up at 0200 on Sunday and all of her joints were aching like crazy. She felt like she had a temperature, but she did not have a temperature. Both of the patients hands swelled really bad. Patient states that she saw her orthopedic doctor yesterday because she couldn't move her joints without pain. The doctor gave her a cortisone injection. Patient states that her joints are still somewhat puffy and sore. States she doesn't know if this is a side effect of the shot or not, but she wanted to report it. Patient mentions that she has arthritis. The joints aching like crazy; Felt like she had a temperature: patient states that these symptoms began on Sunday, 02Oct2022. Couldn't move joints without pain; Hands swelled really bad: Patient saw her orthopedic doctor for this yesterday and was given a cortisone injection. Patient states that this cortisone injection was helpful, her swelling has gone down a bit. States that she is still having some sharp, throbbing pains in her joints. When prompted for specific seriousness criteria the caller replies with no. Then she states that she could not do anything for herself. She couldn't walk, she needed helped to go to the bathroom and get up, she couldn't use her hands or anything to eat; her hands would not bend. Patient mentions that she is scheduled for a diagnostic mammogram this afternoon. States she called them, and they told her to come and have the mammogram done anyway. The patient had no prior vaccinations within four weeks prior to the first administration date of the suspect vaccine and no adverse events following prior vaccinations. The patient had no relevant tests.; Sender's Comments: Based on the available information in the case, the causal association between the events  cellulitis, arthralgia, peripheral swelling and the suspect drug BNT162B2 cannot be 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