Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Cold sweat, Joint range of motion decreased, Limb injury, Magnetic resonance imaging
Clinical narrative: Ended up with like thyroid storm as patient was clammy; Could not rarely use arm and shoulder; COVID-19; COVID-19; tear in left shoulder, injury in bicep/tear in bicep; Hurt arm and shoulder; Hurt arm and shoulder; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4265654-00.  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1155267) at unk (citrate free) and second regimen (Lot number: 1159098) at unk (citrate free), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Mar2022, outcome "unknown", COVID-19 (medically significant) with onset Mar2022, outcome "recovered" (2022) and all described as "COVID-19"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset Mar2022, outcome "not recovered", described as "Could not rarely use arm and shoulder"; LIMB INJURY (non-serious), LIMB INJURY (non-serious) all with onset Mar2022, outcome "recovering" and all described as "Hurt arm and shoulder"; MUSCLE RUPTURE (medically significant) with onset Mar2022, outcome "recovering", described as "tear in left shoulder, injury in bicep/tear in bicep"; COLD SWEAT (non-serious), outcome "recovered", described as "Ended up with like thyroid storm as patient was clammy". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (2022) Tear in shoulder and biceps. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid-19", "tear in left shoulder, injury in bicep/tear in bicep", "hurt arm and shoulder", "ended up with like thyroid storm as patient was clammy" and "could not rarely use arm and shoulder" with the suspect product(s) BNT162b2 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.  Clinical course: Solicited report by a consumer of an adult male with events of non-serious hurt arm and shoulder, could not rarely use arm and shoulder, ended up with like thyroid storm as patient was clammy and COVID-19 with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced hurt arm and shoulder, could not rarely use arm and shoulder, ended up with like thyroid storm as patient was clammy and COVID-19. On an unknown dates, ended up with like thyroid storm as patient was clammy and COVID-19 resolved. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Solicited report by a consumer of a 52 year old male with events of non-serious hurt arm and shoulder/injury in left shoulder, could not really use arm and shoulder, tear in left shoulder, injury in bicep/tear in bicep, ended up with like thyroid storm as patient was clammy and Covid-19 with Humira (Adalimumab) and Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced ended up with like thyroid storm as patient was clammy. In  Mar2022, the patient experienced hurt arm and shoulder/injury in left shoulder, could not really use arm and shoulder, tear in left shoulder, injury in bicep/tear in bicep and COVID-19. In 2022, the COVID-19 resolved. On an unknown date, ended up with like thyroid storm as patient was clammy resolved. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 31Mar2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The events of hurt arm and shoulder and could not really use arm and shoulder were added. On 25Apr2022, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "tear in left shoulder" and "injury in bicep/tear in bicep" were added. The event of "hurt arm and shoulder" was amended to "hurt arm and shoulder/injury in left shoulder. Causality for Humira (Adalimumab) The reporter's causality for the event(s) of hurt arm and shoulder/injury in left shoulder, could not really use arm and shoulder, tear in left shoulder, injury in bicep/tear in bicep, ended up with like thyroid storm as patient was clammy and COVID-19 was not provided. Causality for Pfizer BioNTech Covid-19 Vaccine. The reporter's causality for the event(s) Limb injury (Limb injury), Joint range of motion decreased, Shoulder injury, Torn muscle, Clammy, Covid-19 was Not related (as reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (29Apr2022): This is a solicited follow-up report based on information received by Pfizer (Mfr. Control No.: 22K-163-4265654-00). A contactable consumer (patient) reported that: Updated information included Lab test added. Dose description and lot number of Humira added. Event "Torn muscle" added.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded.