Age: 72.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood creatine phosphokinase, C-reactive protein increased, Myalgia, Pain, Pain in extremity
Clinical narrative: C-reactive protein of 31.3 (high); poly-myalgias; Aching all over; overall aches in the arms and legs/painful bilateral legs; overall aches in the arms and legs/painful bilateral arm pain; This is a spontaneous report from a contactable physician and other health professional. A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE ), via an unspecified route of administration, on 02Mar2021 (batch/lot number was not reported), as 1st dose, single dose, at age 72 years old, for COVID-19 immunization, at a clinic; and simvastatin (trade name unspecified), via an unspecified route of administration, from an unspecified date (reported as "long before Oct2017") to 16Mar2021 (batch/lot number was not reported), at unspecified dose and frequency, for an unspecified indication. Medical history included penicillin allergy, high cholesterol, and being slightly overweight, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No additional vaccines were administered on the same date as BNT162B2. There were no prior vaccinations within 4 weeks. On 06Mar2021, 4 days after the first dose, the patient was aching all over, had overall aches in the arms and legs, had painful bilateral legs and bilateral arm pain. On 07Mar2021, 5 days after the first dose, the patient experienced poly-myalgias. The patient had no fever. On an unspecified date, the patient underwent high sensitivity C-reactive protein test which was 31.3 (high) and blood creatine phosphokinase (CK) was normal. The patient's CRP was usually 3 (unspecified date). The events required physician's office visit on 16Mar2021. Treatment for the events included Depo Medrol 80. Simvastatin was discontinued by the MD on 16Mar2021. On 22Mar2021, the patient went back to his physician and he was no better. He was aching all over on his arms and sides. The reporter believed that there was an adverse reaction and thought it could the simvastatin of maybe the vaccine. The patient repeated the high sensitivity C-reactive protein test on 22Mar2021 with unknown results (pending). The reporter stated that they had the patient stop simvastatin in case there was a reaction, but he got worse instead of better. They were expecting for him to get better. The reporter asked if they should not give the 2nd dose which was due on 23Mar2021, if there are any labs that they should follow besides the High Sensitivity C Reactive Protein, how long will it take to go away and is there any treatment that would be recommended. The action taken in response to the event for simvastatin was permanently withdrawn on 16Mar2021. The outcome of the event "C-reactive protein of 31.3 (high)" was unknown, and the remaining events was not recovered.  Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on the information given in the narrative the causal association between events Pain, Pain in Extremity Lower limb, Pain in Extremity upper limb, Myalgia, C-reactive protein increased  and the suspect vaccine BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.