Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cartilage injury, Exostosis, Fibromyalgia, Insomnia, Magnetic resonance imaging
Clinical narrative: Heart attack; Pain in right leg; Broken heart syndrome; Insomnia/ not sleeping; Fibromyalgia; Urinating a lot; Spurs on hip torn labrum/small cists; Spurs on hip torn labrum/small cists; Received the COVID vaccination and experienced more pain; This is a solicited report from a marketing program facilitated collect received from a consumer (patient) based on information received by Pfizer (manufacturer control number: 21k-163-3988336-00).  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 11Jan2021 and second dose on 01Feb2021 (Batch/Lot number was not reported) both at age of 69 years old via intramuscular single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at citrate free for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On unknown dates in 2021, the patient experienced pain in right leg, broken heart syndrome, insomnia/not sleeping, fibromyalgia, urinating a lot, spurs on hip torn labrum /small cists and received the covid vaccination and experienced more pain. On 16Jun2021, the patient experienced heart attack. In 2021, the heart attack resolved. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. On 16Jun2021, the patient had a heart attack. She was experiencing a lot of pain in her right leg. She was receiving injections in her leg, and also had received the covid-19 vaccination and experienced more pain. Ultra sound happened but she was not sure, but it helped with the pain. she had broken heart syndrome. she had suffered with insomnia, and not sleeping. she had suffered with fibromyalgia. she was urinating a lot, that it was going through her. she had a spurs on her hip torn labrum. MRI discovered that it was small cists. It was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken in response to the events for adalimumab was unknown. The outcome of events heart attack was recovered in 2021, outcome of pain in leg, fibromyalgia, increased urinary frequency and pain aggravated were not recovered, outcome of other events was unknown.  Causality for Humira(adalimumab): The reporter's causality for the events of heart attack, pain in right leg, broken heart syndrome, insomnia/not sleeping, fibromyalgia, urinating a lot, spurs on hip torn labrum/small cists unknown onset and spurs on hip torn labrum/small cists unknown onset with humira(adalimumab) was no reasonable possibility the reporter's causality for the events of received the covid vaccination and experienced more pain was not provided. opinion is that the events of heart attack and urinating a lot are not assessable. opinion is that there is no reasonable possibility that the events of pain in right leg, broken heart syndrome, insomnia/not sleeping, fibromyalgia, spurs on hip torn labrum/small cists unknown onset, spurs on hip torn labrum/small cists unknown onset and received the covid vaccination and experienced more pain are related to Humira(adalimumab). The reporter's assessment of the causal relationship of the events with the suspect pfizer biontech covid-19 vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The information provided is very limited and does not allow a meaningful medical assessment of the case. Patient's medical history, lab investigations, diagnostic procedures, treatment aspects etc would have allowed better to assess the case. However, based on the available information and considering drug event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Heart attack, Pain in leg, Broken heart syndrome, Insomnia, Fibromyalgia, Increased urinary frequency, and Pain. The case will be reassessed further upon receipt of additional information.  There is no reasonable possibility of causal association between the reported events Spurs on hip torn labrum/small cists (Cartilage injury, Bone spur) and suspect product BNT162B2. It is more likely due to patients underlying condition of Rheumatoid arthritis.  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.