Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Diarrhoea, Hypoaesthesia, Influenza like illness
Clinical narrative: a low grade temperature.; had joint aches; Diarrhea; feels numbness; the pain in her hands was gone / my arthritis on my hand went away and I felt better; typical flu like feeling; Her previous vaccines were Moderna. she just had the Bivalent vaccine administered; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "arthrtiis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine moderna (Dose number: unknown, Lot number: unknown), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022, outcome "not recovered", described as "Her previous vaccines were Moderna. she just had the Bivalent vaccine administered"; INFLUENZA LIKE ILLNESS (non-serious) with onset 21Sep2022, outcome "recovered", described as "typical flu like feeling"; THERAPEUTIC RESPONSE UNEXPECTED (medically significant) with onset 22Sep2022, outcome "not recovered", described as "the pain in her hands was gone / my arthritis on my hand went away and I felt better"; PYREXIA (non-serious), outcome "unknown", described as "a low grade temperature."; ARTHRALGIA (non-serious), outcome "unknown", described as "had joint aches"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "feels numbness". The patient underwent the following laboratory tests and procedures: Body temperature: low grade temperature; 99.7, notes: Her temperature was 99.7. Clinical course: No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. A registered nurse (patient) had osteoarthritis and some Arthritis, and because of that her hands throb at night when she wakes up. Her hands have been killing her when she wakes up at night because of it. It had gotten to the point that it was hard for her to hold on to the steering wheel. She had pain all summer that woke her up all night. Patient had an unusual side effect after the Bivalent COVID 19 vaccine on 20Sep2022 at 6-7pm. After receiving it, she had the typical flu like feeling on 21Sep2022. She feels numbness. Patient was achy with a low grade temperature. Her temperature was 99.7. She had joint aches and one bought of diarrhea. She went to bed thinking she would feel better in the morning. When she woke up on 22Sep2022, she had no pain in her hands and she could open them, the pain was gone. Ever since, her hands have been better. It was an unexpected benefit from the Bivalent vaccine. It didn't happen quite in that order. She may be a rare example. She noticed her hands first thing when she woke up before her brain was even thinking. She immediately opened them and it didn't hurt. She looked back as far as she could leading up to this, and nothing was different. Her stomach doesn't tolerate NSAIDS well so she was not taking Celebrex like that. She rarely takes it. NSAIDS over the counter tear up her stomach. If she takes her Celebrex more than twice a week, it tears up her stomach. So she only takes it if she is really in pain. Everything else with her health was as usual. Patient had osteoarthritis and because of her condition she had trouble steering the wheel and could not open her hand, she believes the vaccine has helped her with the pain and she can now open her hand, this occurred two days after she received the vaccine and she wants to know if there are any type of similar previous reports. Caller believes other patients might have experience this but might not find the correlation between the improvement of the side effects and receiving the vaccine. Patient had the covid-19 vaccine recently and her arthritis on her hand went away and she felt better. Patient wants to know if there are any clinical trials regarding the bivalent COVID-19 vaccine and the effect as a pain reliver for patients with osteoarthritis. The events did not require Emergency Room nor Physician Office visit.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2, BNT162B2 OMI BA.4-5 cannot be 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.