Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pulmonary function test
Clinical narrative: unilateral diaphragmatic paralysis; burning shoulder pain; Erythema; swelling that extended to the neck and axilla; This is a literature report for the following literature.  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "reactive airways disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: DIAPHRAGMATIC PARALYSIS (medically significant), outcome "unknown", described as "unilateral diaphragmatic paralysis"; ARTHRALGIA (non-serious), outcome "unknown", described as "burning shoulder pain"; ERYTHEMA (non-serious), outcome "unknown"; INJECTION SITE SWELLING (non-serious), outcome "unknown", described as "swelling that extended to the neck and axilla". The events "burning shoulder pain", "erythema" and "swelling that extended to the neck and axilla" required physician office visit. The event "unilateral diaphragmatic paralysis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: negative; showed interval development of an elevated left, notes: hemidiaphragm; Computerised tomogram thorax: left diaphragm was noted in same location, notes: during inspiration and expiration consistent with diaphragmatic paralysis; Pulmonary function test: showed reduction FVC, TLC and DLCO, notes: DLCO compared to 13 years prior. Therapeutic measures were taken as a result of arthralgia, erythema, injection site swelling.  Clinical course: Patient had a past medical history of reactive airways disease and hypertension, who was seen in the pulmonology clinic shortly after receiving her second dose of the BNT162b2 mRNA COVID-19 vaccine. After her second dose she developed burning shoulder pain, erythema and swelling that extended to the neck and axilla. She went to an urgent care and was advised to treat with ice and NSAIDs, she had a chest radiograph performed which was reported to be negative. Her symptoms persisted and she was sent to the emergency room, chest x-ray showed interval development of an elevated left hemidiaphragm. A CT Chest with inspiratory and expiratory films was performed and the left diaphragm was noted to be in the same location during inspiration and expiration consistent with diaphragmatic paralysis. PFT showed a reduction in her FVC, TLC and DLCO compared to 13 years prior.; Sender's Comments: As per the available information the causality of the event diaphragmatic paralysis with the suspect BNT162b2 can not be ruled out completely. 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 Agency, Ethics committees, and Investigators, as appropriate.