Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hip arthroplasty, Inflammatory pain, Influenza like illness, Pain
Clinical narrative: body will ache; feel like the flu; hip replacement/She said she is old, crippled, disabled and everything; she gets entire body inflammatory response the body will ache; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 64 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE, Manufacturer: Moderna, NDC: Unknown, Lot: 029K20A totally a guess, Expiration: Unknown), administration date: 25Jan2021, when the patient was 63-year-old, for Covid-19 immunization; moderna coviD-19 vaccine (DOSE 2, SINGLE, Manufacturer: Moderna, NDC: Unknown, Lot: 010M20A, Expiration: Unknown, Given at Health Department), administration date: 22Feb2021, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Pfizer, Lot: FF2B89, (NDC, Expiration, Dose given, Time given, Anatomical Location: Unknown), Given at private event under the pavilion), administration date: 01Sep2021, when the patient was 64-year-old, for Covid-19 immunization. The following information was reported: HIP ARTHROPLASTY (disability, medically significant) with onset 19Aug2022, outcome "unknown", described as "hip replacement/She said she is old, crippled, disabled and everything"; INFLAMMATORY PAIN (non-serious) with onset 19Aug2022, outcome "unknown", described as "she gets entire body inflammatory response the body will ache"; PAIN (non-serious), outcome "unknown", described as "body will ache"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "feel like the flu". Clinical course: Caller is a nurse reporting that she just received a hip replacement 2 weeks ago and that she was worried about the inflammatory response she had in conjunction to the new booster of the Pfizer Covid 19 vaccine, Bivalent that she wanted to take. Caller states she has already received 2 doses of the Moderna vaccine and 2 doses of the Pfizer Covid 19 vaccine. She is asking if there are reports of patients who had a hip replacement and took the vaccine, wondering if she had to hold off on getting the vaccine for 5 weeks. She also asks if the Pfizer Covid 19 vaccine causes an inflammatory response, and if that was real. And if that inflammatory response from getting the vaccine would exacerbate the effects of the hip replacement that she just got. The report was related to a study or programme. The reporter was a Registered Nurse. The patient said because currently she had normal inflammatory response post operative hip and if she got entire body inflammatory response the body would ache and feel like the flu and asked whether that would prolong healing time due to inflammatory response. She read that long term pain syndrome was often due to inflammatory response. Asked whether the response would be permanently inflamed. Caller confirmed she received two Moderna Covid-19 vaccines and two Pfizer Covid-19 vaccines. HCP details were unknown. Event date was 19Aug2022. She asked to give her a minute she just had a new hip put in. She said she was old, crippled, disabled and everything. Caller confirmed she was reading from her vaccine card, and she needed to find a pair of glasses. Indication was that she did not want Covid and preferred not to get Covid and die. There was no treatment, she said to learn something or start a new study. Anatomical Location of Administration of Pfizer vaccine considered as suspect was unknow. Vaccination Facility Type was Pharmacy and Health Department. No additional Vaccines were administered on Same Date of the Pfizer Suspect. The Adverse events did not require visit to Emergency Room or Physician Office. The patient received no prior vaccinations (within 4 weeks). The Moderna made her arm extremely swollen and red and she never followed through with the report because report was lengthy and was not worthy. She mixed up and got the next two Pfizer and she was willing to take Pfizer over Moderna and neither were available locally and she may put off a month unless there were studies. Patient's Medical History (including any illness at time of vaccination), Family medical history relevant to adverse events were not provided.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be totally excluded for the reported event of Hip arthroplasty. 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.