Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Ear inflammation, Malaise, Weight, Weight decreased
Clinical narrative: Weak; Has affected his balance; he lost like 35 pounds; Not feeling well; Ear blown up, inflamed; Pseudogout; Hearing loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 2, single (Lot number: ER3737) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), "Stents" (unspecified if ongoing), "Stents in heart" (unspecified if ongoing). The patient had these stents placed quite a few years ago, he goes to the doctor regularly related to this and it is controlled. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. Vaccination history included: BNT162b2 (First dose: 06Mar2021; Lot Number: EN6199; NDC and Expiry Date: Unknown,, Anatomical Location: left arm), administration date: 06Mar2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "Weak", "Not feeling well", "Ear blown up, inflamed", "Hearing loss", "Pseudogout", "Has affected his balance", "he lost like 35 pounds". The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "Not feeling well"; EAR INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "Ear blown up, inflamed"; DEAFNESS (medically significant) with onset 2021, outcome "unknown", described as "Hearing loss"; CHONDROCALCINOSIS PYROPHOSPHATE (non-serious) with onset 2021, outcome "unknown", described as "Pseudogout"; ASTHENIA (hospitalization) with onset 2021, outcome "unknown", described as "Weak"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Has affected his balance"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "he lost like 35 pounds". The event "ear blown up, inflamed" required physician office visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: Lost hearing in one ear; 50 perc in the other ear, notes: Result: Lost hearing in one ear; 50% in the other ear; Unit: Not Provided; Weight: he lost like 35 pounds. Clinical course: States that her husband had the second shot, then he was in the hospital because he had gotten so weak. Caller states that her husband had to quit working. States that he was so weak he had slipped and fell on his knee. Caller states that her husband was diagnosed with Pseudogout in the hospital. He was so weak that he ended up in the nursing home after that for like a month. Caller states that her husband is getting to the point now that he can hardly hear, even with his hearing aids. Caller states that it has also affected her husband's balance, he is going to a specialist on 31Oct2022 to take some tests and see what they can do for that. Caller states that her husband won't get another shot. They know there is another booster, but he said he is not getting anymore. Reporter states that not feeling well occurred right after the first dose of the vaccine. Ear blown up, inflamed: Unable to provide exact date for this particular event. Caller states that it took them a while to get an ENT appointment, it was around May or Jun2021 that they went to the ENT and her husband's ear was inflamed then. Hearing loss: Caller states that they don't really know when this started occurring either.  States that they had to wait on the ENT appointment to take the tests to see how much hearing her husband had lost. Weak: Caller states that her husband was so weak, does not have dates. States that he was so weak he slipped and fell on his knee. Caller verifies that her husband was admitted to the hospital for this but doesn't recall dates or how long he was admitted. After his hospitalization the caller's husband was sent to the nursing home for rehab for about a month. Pseudogout: While admitted to the hospital the caller's husband had some fluid removed from his knee and was diagnosed with pseudogout. Caller states that the pseudogout just took hold of her husband. It took over his whole body, he lost like 35 pounds, and he was so weak that is why he had to go to the nursing home for rehab. Caller states that she does not have all the paperwork for her husband in front of her at this time, she only knows that the events mostly occurred in the same time frame between May and July of 2021. Patient received Booster dose of the Pfizer Covid Vaccine: Received by the caller's husband on 19Dec2021; Lot Number: 3313081A, caller states at least that is what it looks like it says; NDC and Expiry Date: Unknown; Administered in the caller's husband's left arm. Additional Vaccines Administered on Same Date of the Pfizer Suspect: Unknown; caller states that she knows her husband received a flu shot, but date and lot number for that flu shot are unknown by the caller. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): Unknown; caller states that she knows her husband received a flu shot, but date and lot number for that flu shot are unknown by the caller.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201253303 same patient, same product/AE and different dose;