Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Insomnia, Joint swelling, Lethargy, Menstrual disorder
Clinical narrative: bruising; joint/nerve pain all over body; joint/nerve pain all over body; foot pain/burning; foot pain/burning; swelling of joints; menstrual pain (abnormal) missed periods; menstrual pain; Chest pain; ringing in ears; lethargy; insomnia; loss of appetite; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-9 VACCINE, solution for injection), administered in arm left, administration date 30Apr2021 14:00 (Lot number: EW 0172) at the age of 37 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior vaccination . The patient's concomitant medications were not reported. The patient did not receive other vaccines in 4 weeks. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: ER 8729, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 09Apr2021, when the patient was 37 years old, for COVID-19 immunisation. The vaccine was given in a hospital. The following information was reported: CONTUSION (disability) with onset 15Jul2021, outcome "not recovered", described as "bruising"; ARTHRALGIA (disability), NEURALGIA (disability) all with onset 15Jul2021, outcome "not recovered" and all described as "joint/nerve pain all over body"; PAIN IN EXTREMITY (disability), BURNING SENSATION (disability) all with onset 15Jul2021, outcome "not recovered" and all described as "foot pain/burning"; JOINT SWELLING (disability) with onset 15Jul2021, outcome "not recovered", described as "swelling of joints"; MENSTRUAL DISORDER (disability) with onset 15Jul2021, outcome "not recovered", described as "menstrual pain (abnormal) missed periods"; DYSMENORRHOEA (disability) with onset 15Jul2021, outcome "not recovered", described as "menstrual pain"; CHEST PAIN (disability) with onset 15Jul2021, outcome "not recovered", described as "Chest pain"; TINNITUS (disability) with onset 15Jul2021, outcome "not recovered", described as "ringing in ears"; LETHARGY (disability) with onset 15Jul2021, outcome "not recovered", described as "lethargy"; INSOMNIA (disability) with onset 15Jul2021, outcome "not recovered", described as "insomnia"; DECREASED APPETITE (disability) with onset 15Jul2021, outcome "not recovered", described as "loss of appetite". The events "bruising", "joint/nerve pain all over body", "joint/nerve pain all over body", "foot pain/burning", "foot pain/burning", "swelling of joints", "menstrual pain (abnormal) missed periods", "menstrual pain", "chest pain", "ringing in ears", "lethargy", "insomnia" and "loss of appetite" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (16Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of contusion, arthralgia, neuralgia, pain in extremity, burning sensation, joint swelling, menstrual disorder, dysmenorrhoea, chest pain, tinnitus, lethargy, insomnia, decreased appetite. The patient also received the third dose of BNT162B2, administered in left arm on 28Feb2022 at 14:00 for COVID-19 immunisation.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events contusion, arthralgia, neuralgia, pain in extremity, burning sensation, joint swelling, menstrual disorder, dysmenorrhoea, chest pain, tinnitus, lethargy, insomnia, decreased appetite cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200430518 Same reporter, suspect drug, and patient; different events