Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle tightness, Musculoskeletal stiffness, Neck pain, Pain assessment
Clinical narrative: muscle between her neck and shoulder was tightening up so bad; she could not put her left arm down to her side/ difficult to turn her head to drive; much pain/ pain in her neck/ would rate it at a 15 on a pain scale; Stiff neck/ thinks it's the trapezius muscle involved and elevator scapular; This is a spontaneous report received from a Nurse.  A 71-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Nov2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 71 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: diagnosed around the time she was 24 years old. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma; INFLUENZA VACCINE, on 28Oct2024. Vaccination history included: Bnt162b (dose 1), for COVID-19 immunization; Bnt162b2 (dose 2), for COVID-19 immunization; Bnt162b2 (dose 3), for COVID-19 immunization; Bnt162b2 (dose 4), for COVID-19 immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (disability) with onset 12Nov2024, outcome "unknown", described as "Stiff neck/ thinks it's the trapezius muscle involved and elevator scapular"; NECK PAIN (disability) with onset 17Nov2024, outcome "unknown", described as "much much pain/ pain in her neck/ would rate it at a 15 on a pain scale"; MUSCLE TIGHTNESS (disability) with onset 18Nov2024, outcome "unknown", described as "muscle between her neck and shoulder was tightening up so bad"; MOBILITY DECREASED (disability) with onset 18Nov2024, outcome "unknown", described as "she could not put her left arm down to her side/ difficult to turn her head to drive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of musculoskeletal stiffness, neck pain, muscle tightness, mobility decreased.  Additional information: Patient (nurse) informed about how she had been feeling since she received the Comirnaty injection on 11Nov2024. This was her 5th dose and she wanted to get it so she does not get Covid. The first four Covid vaccines she got without any difficulty. All her Covid vaccines were by Pfizer. Does not have vaccine card handy to provide product details, such as lot, NDC, expiration date. The following day, on 12Nov2024, she started to develop a stiff neck, mostly on the right side. On 14Nov2024 the stiff neck became more pronounced and she started using ice and heat. On 16Nov2024, she noticed the stiff neck was starting on the left side of her neck, thinks it's the trapezius muscle involved and elevator scapular. On 17Nov2024 and 18Nov2024, she had significant discomfort; on a pain scale of 1 to 10, she would rate it at a 15. At the end of Sunday, 17Nov2024, she started to get some relief on right side. The right side was starting to improve on Sunday, it was not as severe, but the left side, Sunday into Monday (18Nov2024), she had that much pain that she could not put her left arm down to her side because the muscle between her neck and shoulder was tightening up so bad that she had to keep her left arm close to her body with her elbow and tuck her arm up. She did not keep anything in her house for pain and went to the pharmacy and bought herself naproxen 220 mg. She took naproxen only through 21Nov2024 since it didn't seem to do anything. On 23Nov2024, she started taking Advil and that seemed to have helped a little bit better, it takes the edge off. She was still alternating ice and heat, she was up till one o'clock that morning raiding her freezer for a bag of vegetables. It was difficult to turn her head to drive; she clarified that it was not disabling, its just a pain in her neck. She was "doctoring herself" and thinking every day was going to be a bit better. She did not go to ER since they would think she was drug seeking and she hated drugs. She has not talked to her primary doctor about this yet, has not seen her primary doctor since Feb2024. She was sorry for coughing, she is getting a drink of water. NDC number of Comirnaty 2024/2025 (12y up) was reported as 00069-2432-10.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events musculoskeletal stiffness, neck pain, muscle tightness, and mobility decreased and the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded. The case will be reassessed once new information is available.  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.