Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Fatigue, Inappropriate schedule of product administration, Insomnia
Clinical narrative: First Dose: Date 25Jun2021/Second Dose: Date 06Jul2021; lethargic; slept all day; exhausted; pain in the shoulder; This is a spontaneous report received from contactable reporter consumer or other non HCP. The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 06Jul2021 (Lot number: EW0196, Expiration Date: Sep2021) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "Allergy" (unspecified if ongoing), notes: Allergy; "Water retention" (unspecified if ongoing); "Shoulder issues" (unspecified if ongoing); "Ear issues" (unspecified if ongoing); "allergic to Nickel" (unspecified if ongoing), notes: he was allergic to Nickel. Concomitant medication(s) included: LOSARTAN POTASSIUM taken for blood pressure abnormal, stop date: Jun2021; HYDROCHLOROTHIAZIDE taken for blood pressure abnormal, fluid retention, start date: Jun2021. Past drug history included: Allergies: amoxicillin, reaction(s): "Allergies: amoxicillin", notes: Allergies: ciprofloxacin and amoxicillin.; Allergies: ciprofloxacin, reaction(s): "Allergies: ciprofloxacin", notes: Allergies: ciprofloxacin and amoxicillin. Vaccination history included: Bnt162b2 (Dose:1, Expiry Aug2021, Lot EW0181), administration date: 25Jun2021, when the patient was 59 years old, for Covid-19 Immunization, reaction(s): "Aches in the shoulder", "Being tired". The following information was reported: LETHARGY (non-serious) with onset 2021, outcome "unknown", described as "lethargic"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "slept all day"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "exhausted"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "pain in the shoulder"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Jul2021, outcome "unknown", described as "First Dose: Date 25Jun2021/Second Dose: Date 06Jul2021". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:-Caller states that he is calling about the COVID-19 Vaccine. He had the first and second dose in #. With the first 2 vaccines, there were issues and some Side effects but nothing serious. He then had the booster in Jan2022. He had a issue that he's never had before and got concerned. He is going to see his Ear, Nose and Throat doctor (ENT Doctor), he is seeing the ENT doctor next Wednesday, he having it in the left ear, he's also got a left shoulder thing in which it feels like ants are running up the side of his shoulder, up into the neck and left ear. They looked at him in urgent care and said his Blood pressure was fine, all the stats were fine, but he is still getting this issue, its not continuous, it's occasional, but today it happened 6 times, it comes and goes, he's never had that before. He's not an anti vaxxer, he is actually glad he got the shot, he is pleased, he works with lots of people. He is going to find out next Wednesday with the ENT doctor what's going on with the ear. When he went to urgent care last week, the doctor couldn't see the inner ear because it was swollen, he's never had that happen before. He took the day off from work, and has missed 3-4 days of work because of this, he's got to get something done, he can't work with way his arm is, the left arm, he then clarified it's not the arm, its just the shoulder really. It's a buggy feeling crawling up. His blood pressure and pulse are fine. That's why he called, he is concerned, after the first and second shot it wasn't a big deal, but he has had this after the 3rd dose on 29Jan2022. When probing when the issues in the Left ear began, he states that it was noticed after the shot in Jan2022, he probably didn't notice it for 3 weeks, he initially actually noticed the shoulder, and unusual things with the left shoulder, like there was a little weakness in shoulder, it was sore, it was restless, just not usual. He clarified that the Shoulder issues began Feb2022. The left Ear issues came after, in the middle of Mar2022. The Inner ear being swollen was discovered at Urgent care on 24Mar2022. He want to clarify that he has had issues with his Ear and shoulder prior to the COVID vaccine, but never had them in a combination or like this. He understand that it could be allergies or a lot of things going on, that's why he is going to go to the ENT next week, at urgent care he was told he has Acute Otitis Externa, the Inner ear is swollen and the doctor couldn't see inside. He's had wax in the ear always, but they have still been able to see in the inner ear canal but this time they couldn't. He has had some ear and shoulder issues prior but not like this or in combination. HCP: He has been to the doctor last month and month before, and they have cleaned out wax on the first visit. HCP Full Contact Details are Unknown. Caller explains that the Shoulder issues and Ear issues are Ongoing, they have not gotten worse, but are still persisting about the same. When probing for anatomical location of all 3 vaccines, caller is unsure, for the Booster dose he believes it was the Left Arm, he is pretty sure it was the left arm. Concomitant Medication includes that he's not on anything new, he is taking the blood pressure medication Hydrochlorothiazide, he was prescribed last year. In changes along the time of the shots, he recalls that he was put off of losartan potassium prior to the first dose. He was put on Hydrochlorothiazide some time in Jun2021. Caller clarified that Losartan potassium was stopped in Jun2021 and hydrochlorothiazide was started. He also wants to add that he didn't feel real good after the 3rd shot, he felt different, he felt like his body had changed, he was tired, he felt different. He went to see the doctor, he was seen for the ear, the last time was 4-5 months ago, then prior to that he was seen at the doc after the first shot, and before that was Feb2021. It was after the second dose is when the ear started giving problems. When clarifying with the caller that he said the ear issue started in middle of Mar2022 which would have been last month but said that he went to ear doctor for the ear issues 4-5 months ago and that this did not match what he previously said caller said this is right and did not clarify. Attempt was made to clarify. He adds that after the first shot, there was no problem but aches in the shoulder and being tired. With the Second shot he got lethargic, slept all day, he was exhausted, wipe out, he had pain in the shoulder but didn't get sick or have a fever, he just got really tired. He noticed his blood pressure last visit with Dr. (name withheld) was a little elevated, the Blood pressure is still a little elevated, he hasn't changed anything, he initially states that his Blood pressure is usually 72 over 144 or 71 over 144, caller then corrects himself he would be dead if that was the case and says the blood pressure was usually 144 over 72 or 144 over 71, that's normal for him, after that he went to urgent care and in the last 3 months it been elevated, at urgent care it was 166 over 81 on 24Mar2022. Medical Conditions includes that he had no other issues besides the high blood pressure, there was issues and he's always has had water retention before even before the shots, the water retention is in the legs, but it has cleared up with the hydrochlorothiazide. On 06Jan2022, he saw Dr. (name withheld) for laboratory work, he had a cough and got a Viral URI with Cough screening it was a lab test for COVID-19 virus, he took the test on 06Jan2022 at urgent care his blood pressure was 144/90 and the Result to the Viral URI with Cough screening came back negative. He would like to know if these are side effects. He knows his mind and body are well enough but after the 3rd shot, he noticed a difference in his body metabolism, he is sluggish, he doesn't have any issues that the doctor is concerned about and needs to think about what he did or what happened prior. The doctor told him he is pretty good, the last physician in Jun2021 said he was aging properly. The changing of the Blood pressure medication from losartan potassium to hydrochlorothiazide was to address the water retention, which it has subsided. Caller clarified that he has tested negative, the first test was negative or the second test. Caller clarified that they were COVID tests at # Urgent Care. He also wants to add that after the 3rd shot, he has memory fog too, he is 60-year-old, not old, pretty young still getting carded at grocery stores. He noticed a change in his physical and mental state, he was watching his body really closely. He works at auto parts store. With the 3rd shot he was hesitant but he knows he will not get the 4th shot. He wants to add that he's always masked up with N95 through whole pandemic. Since he has masked up he has never tested positive for covid. He has missed a weeks worth of work, he's home all week.  No follow up attempts are possible. No further information is expected.