Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin M increased, Blood test, COVID-19
Clinical narrative: The IgM numbers spiked unlike any blood work. 825 to 1151.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 82 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2021 13:00 (Lot number: EL3246) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "IgM MGUS" (unspecified if ongoing); "Peripheral neuropathy" (unspecified if ongoing); "Type II diabetes mellitus", start date: 2010 (unspecified if ongoing); "Barrett's esophagus", start date: 2000 (unspecified if ongoing); "some anti-lipids" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN; FLUOXETINE taken for Barrett's oesophagus; PROTONIX [OMEPRAZOLE] taken for Barrett's oesophagus, start date: 2000; NEURONTIN taken for neuropathy peripheral, start date: 2000; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; PROSCAR; METFORMIN, start date: 2010; PROZAC. The following information was reported: BLOOD IMMUNOGLOBULIN M INCREASED (non-serious) with onset 09Feb2021, outcome "recovering", described as "The IgM numbers spiked unlike any blood work. 825 to 1151.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood immunoglobulin m increased.  Additional information: Reporter provided the PQC Details Request Name: REQ-208955, REQ-209027, REQ-209032 Product PFIZER-BIONTECH COVID-19 VACCINE. Question: Caller (male, age 82) took both doses of the Pfizer vaccine. He already reported to Drug safety prior to transfer. He has igm monoclonal gammopathy waldenstrom macroglobulinemia (IgM monoclonal gammopathy of undetermined significance) orphan cancer - like multiple myeloma. The numbers (from his blood work) creep up over the years, every 6 months (they monitor his number IgM protein) or occasionally slightly down. After the 1st dose which was on 26Jan2021 he received blood work myeloma panel on 9Feb2021 (it was scheduled prior) and he received the 2nd shot on 15Feb2021. The IgM numbers spiked unlike any blood work. 825 to 151. After years of having this condition it may go to 750 or 760 but not 1151 never like that before. Question: any knowledge of this phenomena. Will my IgM return to normal levels (will it return to my normal levels). My doctor had me repeat of panel and also have blood work relative to covid antibodies. Will my numbers go down to my normal. One of the treatments for covid is monoclonal antibodies (I have excess of monoclonal gammopathy). This disease can be cured with monoclonal antibodies; there must be a relationship. Dates for IgM levels shooting up to 1151 From 9 Feb 2021 To Unknown. Additional Information for Other Conditions Caused high IgM, and is how his disease was discovered. The caller feels peripheral neuropathy is not related to COVID vaccine. Caller states he had two Pfizer COVID19 Vaccine shots. Caller states they have never been this high before. Caller states his prior levels were 825 in August 2020. Caller also states based on history his levels would have been some where around 860 or 760. Caller states he has had this diagnosis for many years and expects spikes up or down, but not this big. Caller states that he belongs to a forum called IWMF (International Waldenstrom's Macroglobulinemia Foundation) and it has a website that has reports of this occurrence in other people. It is a website of people that are interested in this disease. The website is IWMF.com and phone number is [Redacted]. Caller states yesterday there was some information that indicated there may be some link to the COVID19 vaccination and IgM MGUS. Caller states he called the nurse practitioner who works with his cancer doctor and offered to send them the info and nurse said that the doctor is aware and told the caller that he is not the only one. Caller states he feels that the article that was posted on this site indicates that someone is researching it. Caller states that no one that has been inoculated, has been inoculated long enough, so it's too early to tell. States he just got more blood work drawn yesterday, because the doctor told him to wait 30 days from the last test, then get the bloodwork over again, as well as an antibody count. States that he has heard of people with his diagnosis that have had COVID 19 Vaccination shots and found that they really haven't gotten any additional antibodies. No further details provided. Caller states he will have his bloodwork results in a couple of days, which will reveal his new IgM level and what his antibody count is. Now that he's gotten his 2nd vaccine, he is wondering if his IgM count will be even higher; he's hoping it will be less. Received his 2nd dose of the COVID vaccine on 15 Feb 2021 at 1500. Lot:EL9265, NDC/Expiry: Unknown. In left should the patient has not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination is Pravastatin 40 mg Generic Prozac. 20 mg (fluoxetine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Test Name: anti-body to Covid. Reported Event: I have IgM MGUS. My last bloodwork prior to the vaccine was 852. I have never had an increase in a 6 month period of more than 50. Blood work between the 2 shots went to 1151. 1st shot 1/26. 2nd shot 2/15. blood work 2/9. repeat blood work 3/23. IGM 950. The patient had no Covid prior to vaccination. Allergies to medications, food, or other products:some anti-lipids. known allergies: some anti-lipids.  No follow-up attempts are needed. No further information is expected.