Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: pain at pelvic girdle area to posterior side area; It was so intense I could not sleep in bed that night; I just have a lot of pain and disability since then/pain of 8 to 10 level; This is a spontaneous report received from a Physician from medical information team.  A 79-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jul2024 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history included: "stent", start date: 2020 (unspecified if ongoing), notes: Had a stent placed in 2020; "proctectomy", start date: Sep2022 (unspecified if ongoing), notes: proctectomy which was in Sep2022; "hypercholesteremia" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First dose:, Pfizer COVID-19 vaccine, Date: 06Jan2021, NDC, lot, expiry: Unknown, does not have the information at time of call), administration date: 06Jan2021, for Covid-19 Immunization; BNT162b2 (Second dose:, Pfizer COVID-19 vaccine, Date: 27Jan2021, NDC, lot, expiry: Unknown, does not have the information at time of call), administration date: 27Jan2021, for Covid-19 Immunization; BNT162b2 (Third dose:, Pfizer COVID-19 vaccine, Date: 25Oct2021, NDC, lot, expiry: Unknown, does not have the information at time of call), administration date: 25Oct2021, for Covid-19 Immunization; BNT162b2 (Fourth dose:, Pfizer COVID-19 tris 12 plus , Date: 09Apr2022, NDC, lot, expiry: Unknown, does not have the information at time of call), administration date: 09Apr2022, for Covid-19 Immunization; BNT162b2 omi xbb.1.5 (Fifth dose:, Pfizer BVLN BSTR 12 plus, Date: 20Dec2022, NDC, lot, expiry: Unknown, does not have the information at time of call), administration date: 20Dec2022, for COVID-19 immunisation; comirnaty (2023-2024 formula) (Sixth dose:, Pfizer Comirnaty 12 plus , Date: 10Oct2023, NDC, lot, expiry: Caller found a vaccination card that has information only for this dose, says HG4432, then WAG3343, doesn't know what that means but is written under HCP or clinic site), administration date: 10Oct2023, for COVID-19 immunisation. The following information was reported: PAIN (disability, medically significant) with onset 04Jul2024, outcome "not recovered", described as "I just have a lot of pain and disability since then/pain of 8 to 10 level"; PELVIC GIRDLE PAIN (non-serious), outcome "not recovered", described as "pain at pelvic girdle area to posterior side area"; INSOMNIA (non-serious), outcome "unknown", described as "It was so intense I could not sleep in bed that night". The patient underwent the following laboratory tests and procedures: Aldolase: Unknown Results; Blood cholesterol: High; Fell nicely; C-reactive protein: Normal; Sed rate: normal; Muscle enzyme: Unknown Results; Pain assessment: 8 to 10 level. Therapeutic measures were taken as a result of pain, pelvic girdle pain, insomnia.  Clinical course: Patient stated that he got a covid booster last 03Jul2024 and 20 hours later he had sudden onset of pain at pelvic girdle and down in posterior side area gradually it spread and felt  it occasionally in his calf area but generally the biggest area pelvic girdle and posterior side area. It was so intense he could not sleep in bed that night. It seemed like it was going away over about a month but it did not go away and came back fairly significantly roughly in Oct. Just this summer had seen his doctor 3 times and nothing has been prescribed basically. Did muscle enzymes CPK and aldolase. Did a Sed rate and CRP they are normal but doctor was basically trying to figure out where to send him to. He had seen acupuncture, he used Tylenol and Naproxen. He was going to be seeing a physician in physical medicine specialize in pain. He just had a lot of pain and disability since then. He stated that it's been a real problem. So he got up in the morning the pain level and he had to follow in the kitchen and the pain level will be an 8 or 10 level. He needed a little resting off and on and get back around. Patient stated then gradually typically as the day goes by he started feeling better and over the last few months, 2 months maybe he looked more on long covid and what are the experiences with that and what is been used to that. He was quite on a variety of supplements and tried stopping them. It did not make any difference but what he did settle on here recently some people are using creatine and getting some benefit on long covid. He was quite on a variety of supplements and tried stopping them. It did not make any difference but what he did settle on here recently some people are using creatine and getting some benefit on long covid. He started doing that about 2 or 3 weeks ago and seem like maybe cutting edge on it.  Upon transfer caller confirmed details provided by agent, stating caller has one slight correction, caller said 8 to 9, stating 10 is really bad pain, caller had a prostate issue and had to wait 1.5 hours three times to get catheterization, and that hurts like hell, this is close to hurting like hell. When gets up and walks in morning is more like 8 to 9 on worst days, over last week has had less pain, can explain further. Calling to report the adverse event and try to get insight into this, is going to see another doctor. Has been a real puzzle. Caller started getting the Pfizer vaccinations as soon as available, thinks this was caller's seventh dose, confirmed all seven doses were the Pfizer COVID vaccine. Pain: Pain came on suddenly, at first felt like was sitting wrong, then over about a 15 to 30 minute period got more intense. Stop date, outcome: Ongoing, has shifted a bit, not as intense in gluteal area, is more over the greater trochanter and posterior thigh. Doesn't bother caller when sleeping or sitting, but when walks, if walks far, starts to hurt, has to be careful, some days feels good, hasn't walked a mile in a month. Just shopping and walking around house. When overdoing it then next day is very sore. Seriousness: Medically significant and disabling, therefore disabling selected in formal field since caller provided both. Caller's wife has moderate dementia, so caller runs the whole house, caller does cooking and laundry. Someone else cleans. Caller had never realized how much chronic pain adversely affects everything you do, think, incentive, energy, this is where caller is, life is just kind of, then stated hardly travels at all anymore with the chronic pain and getting up in morning and knowing hardly able to walk into kitchen.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the information available and plausible temporal association, the causal relationship between the reported event PAIN  and suspect drug BNT162B2 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.