Sex: F
Vaccine: COVID19
Symptoms: Abnormal menstrual clots, Arthralgia, Blood pressure measurement, Body temperature, Erythema
Clinical narrative: Bucking knee; Period delayed to 39 days; Lots of clots (with her periods); joint stiffness; joint pain; erythema; left arm numb; HERO-TOGETHER: A POST-EMERGENCY USE AUTHORIZATION OBSERVATIONAL COHORT STUDY TO EVALUATE THE SAFETY OF THE PFIZER-BIONTECH COVID-19 VACCINE IN  HEALTHCARE WORKERS  This is a non-interventional study report (Post Authorization Safety Study) received from contactable reporter(s) (Other HCP) for protocol C4591008.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 2, 30 ug single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Pregnancy losses" (unspecified if ongoing), notes: (three first trimester miscarriages); "Coagulation abnormality" (ongoing), notes: (Low levels of both protein C and protein S) not have antiphospholipid antibody; "Floaters and retinal detachment" (ongoing), notes: First episode to right eye five year ago; "Floaters and retinal detachment" (ongoing), notes:  recently a problem detachment with left eye; "severe myopia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin for drug allergy, notes: ongoing. Vaccination history included: coviD-19 vaccine (DOSE 1, SINGLE via IM), administration date: 28May2021, for COVID-19 prophylaxis. The following information was reported: ERYTHEMA (non-serious) with onset Dec2021; ARTHRALGIA (disability) with onset Dec2021, described as "joint pain"; JOINT STIFFNESS (disability) with onset Dec2021; HYPOAESTHESIA (non-serious) with onset Dec2021, described as "left arm numb"; ABNORMAL MENSTRUAL CLOTS (non-serious) with onset Sep2022, described as "Lots of clots (with her periods)"; MENSTRUATION DELAYED (non-serious) with onset Nov2022, described as "Period delayed to 39 days"; JOINT INSTABILITY (non-serious) with onset Dec2022, described as "Bucking knee". Clinical course: On 14Feb2022, the patient presented to the doctor's office for follow-up with rheumatology to evaluate joint swelling after COVID vaccine and arthralgias (inflamed right hand-proximal interphalangeal joint (PIP)). The patient's general health had been good, but over the last year she had noticed several different problems including shingles (AER 202200582310), episodes of swelling (AER 202200582310), and joint stiffness. Five days after her first COVID shot, the participant developed shingles with herpetic lesions on her right thigh. Initially, she had a lot of itching around the lesions and had postherpetic pain. By the time she saw her physician, it was too late to use antivirals. The patient experienced several episodes of swelling that had been transient. Some of the episodes have been associated with itching and some with few symptoms. The first episode started about a month after her first COVID shot and involved her eyes, with left eye more involved than right eye. She also complained of pain and tenderness below her right eye. On an unknown date, she also had an episode of swelling on her right upper lateral thigh that left a bruise and an episode of swelling on her left lower thigh. The patient had also experienced redness and swelling on the dorsum of her right third and fourth fingers. The erythema had largely resolved, but she still had swelling in these areas. The swelling did not appear to involve the joints. The symptoms began after her second COVID shot in Dec2021. The patient noted a lot of stiffness in her joints in the morning, particularly in her PIP joints. She described the stiffness as a tightness that could be 8 or 9 out of 10. In the tips of her fingers and toes, she had dysesthesias that came and went, but is not associated with any color change. She had some erythematous bumps on her upper chest. These were not itchy or painful but were persistent. Vital signs at this current visit on 14Feb2022 were blood pressure 109/67, pulse 69, and temperature 36.6 Celsius. The patient was well appearing and in no acute distress. Patient reported hand pain with a pain scale of 2. Review of systems remarkable for: skin with thickening of the dorsum of her right third and fifth PIP joints without any erythema or tenderness; faint bruise, palm size to right upper outer thigh; eyes with no conjunctival erythema, eyelid, or periorbital edema. Musculoskeletal exam of the bilateral upper and lower extremities was unremarkable and revealed normal active and passive range of motion without pain. Examination of the axial musculoskeletal system including head, neck, spine, ribs, and pelvis was negative. Musculoskeletal exam negative for enthesitis and no tender points noted. Physician impression at visit on 14Feb2022 was that the participant had a number of different problems that came and went, but so far, no diagnosis had been established. Swelling and erythema that had occurred in several areas could be angioedema or less likely urticarial vasculitis. The area on her right upper lateral thigh left a bruise and she had some persistent swelling of the skin on her PIP joints. Both of these finding suggested significant inflammation in these areas. Stiffness in the morning especially with PIP joints could possibly be early osteoarthritis. Suggestion to try paracetamol (TYLENOL) arthritis 1-2 times per day. The patient had one episode of shingles and was at risk for another episode; recommended Shringrix vaccine. Physician assessment: "She was concerned that some of the problems she had might be related to the COVID shot but this seems unlikely. Would recommend that she get COVID booster at the appropriate time." Diagnosis/clinical impression: Shingles, Swelling and erythema, Joint stiffness. Therapeutic measures were taken as a result of joint stiffness, erythema. The action taken in response to the events was not applicable. The outcome of event "left arm numb" was unknown, of events "joint stiffness", "joint pain" and "erythema" was not recovered, of events "lots of clots (with her periods)" and "period delayed to 39 days" was unknown, of event "bucking knee" was recovered.  The reporter considered events "joint stiffness", "joint pain", "left arm numb", "lots of clots (with her periods)", "period delayed to 39 days" and "bucking knee" related to BNT162b2, while event "erythema" not related to BNT162b2. The reporter considered all events not related to concomitant medications.  Follow-up (21Jul2022): This is a follow-up report from a non-interventional study report (Post Authorization Safety Study) received from a contactable reporter(s) (Other HCP) for protocol C4591008. Updated information included: patient's Race. COVID-19 vaccine (Intramuscular for COVID-19 prophylaxis) was taken Once from 28May2021 to 28May2021. COVID-19 vaccine (Intramuscular for COVID-19 prophylaxis) was taken Once from 01Dec2021 to 01Dec2021.  Follow-up (18Jan2023 and 24Jan2023): This is a follow-up report from a non-interventional study report (Post Authorization Safety Study) received from a contactable reporter(s) (Other HCP) for Protocol C4591008. Updated information: reaction data (added events "joint pain", "left arm numb", "lots of clots (with her periods)", "period delayed to 39 days" and "bucking knee", updated event "joint stiffness" seriousness criteria from "non-serious" to "disability" and causality from "unrelated" to "related", removed event "essential tremor").  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the known safety profile of vaccine and the information available the event Erythema was considered unrelated to the suspect drug.  Based on the temporal relation, the association between the events of joint stiffness, arthralgia, hypoesthesia, abnormal menstrual clots, menstruation delayed and joint instability and the suspect product cannot be completely ruled out.  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.