Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Stress, Weight, Weight decreased
Clinical narrative: EMG; fluid around muscle around left bicep and swelling in left hand /his left hand started swelling; muscle was abnormal; severe progressively worsening pain after the Pfizer COVID-19 Vaccine booster dose/started having a lot of pain all over; asked for reports with problems with muscles or muscle pains after the Pfizer COVID-19 Vaccine booster dose.; lost a lot of weight on Jardience; Stress; depression; she tried to help him he would scream out in pain,especially in left shoulder.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 80-year-old male patient received BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing), notes: diabetes type 2 diagnosed years ago. Concomitant medication(s) included: JARDIANCE taken for type 2 diabetes mellitus, start date: Jan2022; SHINGRIX, on 07Oct2021. Past drug history included: Metformin, notes: Patient had been taking Metformin for Type 2 diabetes for years. Vaccination history included: BNT162b2 (Second dose administered on 23Feb2021, LOTEN6202), administration date: 23Feb2021, when the patient was 79-year-old, for COVID-19 Immunization; BNT162b2 (First dose administered on 05Feb2021, LOT- EL9269), administration date: 05Feb2021, when the patient was 79-year-old, for COVID-19 Immunization. The following information was reported: ELECTROMYOGRAM (medically significant) with onset 2021, outcome "unknown", described as "EMG"; STRESS (non-serious) with onset 2021, outcome "not recovered"; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "asked for reports with problems with muscles or muscle pains after the Pfizer COVID-19 Vaccine booster dose."; DEPRESSION (non-serious) with onset 2021, outcome "not recovered"; PERIPHERAL SWELLING (medically significant) with onset 2021, outcome "not recovered", described as "fluid around muscle around left bicep and swelling in left hand /his left hand started swelling"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost a lot of weight on Jardience"; MUSCLE DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "muscle was abnormal"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "severe progressively worsening pain after the Pfizer COVID-19 Vaccine booster dose/started having a lot of pain all over"; ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "she tried to help him he would scream out in pain,especially in left shoulder.". The events "fluid around muscle around left bicep and swelling in left hand /his left hand started swelling", "muscle was abnormal", "severe progressively worsening pain after the pfizer covid-19 vaccine booster dose/started having a lot of pain all over", "asked for reports with problems with muscles or muscle pains after the pfizer covid-19 vaccine booster dose.", "lost a lot of weight on jardience", "stress", "depression" and "she tried to help him he would scream out in pain,especially in left shoulder." required physician office visit. The patient underwent the following laboratory tests and procedures: Blood glucose increased: (2021) blood sugar was then high., notes: blood sugar was then high; (2021) dropped significantly very fast; Blood test: (2021) range or normal, notes: Caller confirmed that husband had no ALS; Electromyogram: (2021) muscle was abnormal, notes: EMG", a procedure where "they put needles in muscles, starts at the tip of his fore finger all the way up to arm, to elbow" was performed on her husband. Caller mentioned that the procedure "was painful" and her husband "couldn't take anymore of it"; Glycosylated haemoglobin: (2021) down to below 7; Test: (2021) normal; Magnetic resonance imaging: (2021) found he had fluid around bicep muscle in the left, notes: did an MRI and found he had fluid around bicep muscle in the left arm; Weight: (2021) Loss. Therapeutic measures were taken as a result of peripheral swelling, muscle disorder, pain, myalgia, stress, depression, arthralgia.  Clinical course:Caller called on behalf of her husband and asked if anyone else had reported "severe progressively worsening pain after the Pfizer COVID-19 Vaccine booster dose". Caller also asked for reports with problems with muscles or muscle pains after the Pfizer COVID-19 Vaccine booster dose. Caller stated that her husband was seen by different doctors/HCPs. Caller was seen by a neurologist "trying to get relief from pain". "EMG", a procedure where "they put needles in muscles, starts at the tip of his fore finger all the way up to arm, to elbow" was performed on her husband. Caller mentioned that the procedure "was painful" and her husband "couldn't take anymore of it". Caller also mentioned that the neurologist said "all" her husband's "muscle was abnormal". The HCP thought it was ALS but couldn't diagnose as they don't have the training. Caller's husband was then seen by his primary care physician and other doctors. Tests including blood test were done on husband. Caller confirmed that husband had no ALS and results "were in range or normal". Caller mentioned that they've been seeking guidance from HCPs for "months now". Husband was seen by "spine doctor, 2 neurologist, orthopedist, a diabetic doctor, and now going to see a rheumatologist".Patient had been taking Metformin for Type 2 diabetes for years and the doctor put him on Jardiance also for diabetes. Clarifies the Jardiance was prescribed in Jan2022, states the pain started prior to taking this medication. Patient lost a lot of weight on Jardience, doctor said it could be normal to lose 15 or so pounds, but also told them his blood sugar could have dropped significantly very fast and caused neuropathy which would ex-plain the pain possibly, Jardience.Doctors took patient off the Jardiance and cut in half his metformin, blood sugar was then high. First neurologist said that he was sure the patient had ALS and caller states her husband just gave up at this point because he was in so much pain was on sofa and bed all the time with the stress of that diagnosis Caller states her husband went to see another neurologist and this doctor confirmed the patient did not have ALS, and they began looking for other autoimmune diagnosis and doing a lot of tests, states they took 8 vials of blood and all the tests look normal and came back within range, specific details of tests not provided. Husband went back to the primary care provider and he prescribed him medication for pain and depression, caller states the patient just started these. In the meantime he was to the point he could not put on clothes or do anything, if she tried to help him he would scream out in pain, especially in left shoulder. States then his left hand started swelling, did an MRI and found he had fluid around bicep muscle in the left arm. Doctors are currently debating starting the patient on steroids.Patient received the Shingles shot within a week of the COVID booster, clarifies that the shingles shot was administered on 07Oct2021.  Follow-up attempts are completed. No further information is expected.