Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Impaired work ability, Off label use, Product use issue
Clinical narrative: he experienced lower back pain and it became more painful.; It's lower back pain, and then also the muscle around his hips; Additional Vaccines Administered on Same Date of the Pfizer Suspect: Yes. Vaccine Name: High Dose Flu Shot; Offlabel use; can't function well while working; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 66 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 05Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series complete: , Unknown manufacturer), for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 05Oct2022, outcome "unknown", described as "Additional Vaccines Administered on Same Date of the Pfizer Suspect: Yes. Vaccine Name: High Dose Flu Shot"; OFF LABEL USE (non-serious) with onset 05Oct2022, outcome "unknown", described as "Offlabel use"; ARTHRALGIA (non-serious) with onset 06Oct2022, outcome "not recovered", described as "It's lower back pain, and then also the muscle around his hips"; BACK PAIN (non-serious) with onset 06Oct2022, outcome "not recovered", described as "he experienced lower back pain and it became more painful."; IMPAIRED WORK ABILITY (non-serious) with onset Oct2022, outcome "unknown", described as "can't function well while working". Therapeutic measures were taken as a result of back pain, arthralgia, impaired work ability.  Additional information: It was reported that patient had Pfizer booster shot last Wednesday of this month and immediately after getting vaccinated he experienced lower back pain and it became more painful. Caller wants to know more information about the side effects of the vaccine. he got his Pfizer COVID-19 Booster shot on Wednesday 05Oct2022, and he got at the same time his Flu shot as well (manufacturer of Influenza vaccine was not verified). He got the vaccine through company, the group that has came in to his office. He was on vacations right after that. It's lower back pain, and then also the muscle around his hips, that was the only basically, but it was debilitating in some ways because he could not necessarily walk, and he usually does exercise but he has not been able to do exercise because he just does not feel comfortable. He stated he is 66 and he's usually pretty limber, but it's been like Ugh you know, tough. He read something about a potential issue with the lower back pain from Pfizer, that there was a build up of "Creatinine maybe or something, he was not sure of the actual or if that's correct either" but, he was just overlooking it and they seemed to have a remedy for it, and thought of calling us to reach out for help, if there was something about an issue with build up in the hip joint or in that area, and that you have to take a blood test for that, he stated he's just having a hard time and thought he'd reach out to Pfizer. No other conditions reported. No investigations performed. As a kid was 5ft 9 inches, now 5ft 8 inches Primary / Prescribing Healthcare Professional Info: Has an old doctor who has now retired. He has a new doctor he has not seen due COVID and did not have details to provide. He state he will call the other doctor about Lower back pain. He went to the Chiropractor about this. He then added, he read something about that there may be a build up in the system of a particular chemical. Communication: Difficult to understand reporter's full statement. Attempted to clarify name of chemical reporter stated initially, but he declined to repeat it. Reporter stated he did not want to say anything wrong because he did not read it fully. From what he read, this particular chemical was helping inflame the situation. The person taking this found out through blood test and was a jogger. He is just going through the process in researching what's up. He then added, in the article it was noted she went to the doctor's office and found out there was a higher chemical causing inflammation in lower back and hips and causing weakness. However, he did not read to much into . He just saw they were able to run again later and he would like to. Attempted to clarify details further regarding the statement, person taking this and what it was regarding. The reporter was unable to further clarify statement and no further details were provided to clarify what specifically person was taking. Outcome of lower back pain: Attempted to clarify outcome, but reporter only provided as he cannot lay flat flat. That is how he usually sleeps. There is some discomfort. Pain in the muscle around hips-Outcome of pain in the muscle around hips: Attempted to clarify outcome and mentioned he tries to stretch. Today he could touch his toes. Some days he cannot touch his toes. Treatment- He has been taking Aleve and Turmeric and another anti-inflammatory. It seems like these work, but not always. Aleve Lot: 1MRO462 Exp: Jul2023 He does not always take Aleve, tries not to take it. Turmeric- Lot/exp/UPC, not provided Product Details: Confirmed did not have details to provide lot/exp/NDC for the Pfizer COVID Booster. His wife has that information. Clarified the flu shot to be the High Dose Flu Shot. Investigations: Confirmed has not had any yet, but may try to get some due to information he has seen. Patient reported that additional vaccines were administered on Same Date of the Pfizer Suspect i.e.High Dose Flu Shot. Adverse Events Lower back pain and Pain in the muscle around hips occurred the next day afterwards. No information about Emergency room visit, Physician office. No information about Prior Vaccinations (within 4 weeks). AE(s) following prior vaccinations were None or Unknown. No Family Medical History Relevant to AE(s). No Relevant Tests performed. Caller wants to know more information about the side effects of the vaccine. He was trying to see a doctor about this but he saw the Pfizer number. He also mentioned that he can't function well while working.   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.