Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: tired; felt like, just tired, or tuckered out feeling; soreness in his arm, injection site tenderness; kind of warm; Malaise; This is a spontaneous report from a contactable consumer reported for himself a 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FL3302; Expiration date was not reported), via an unspecified route of administration, in Left Arm on 28Jan2021 09:00 (at the age of 56-years-old) as DOSE 1, SINGLE for covid-19 immunisation at vaccine clinic. The patient administered second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6203, Expiration date: Unknown), via an unspecified route of administration on 23Feb021 for Covid-19 immunisation. Patient took vaccine just because he wanted to make sure he was protected, and the clinic was offering it. He had an underlying condition, Diabetes, and being that he had this he wanted to make sure he got it. The patient medical history included ongoing diabetes mellitus, ongoing tremors from an unknown date, visual impairment (caller did not provide specific dates), weight decreased, from an unknown date and unknown if ongoing. States he had been losing weight and it had been coming down. He was trying to get back to where it was. Caller confirmed this occurred prior to the vaccine and he just started paying attention to what he was eating, it was not from the vaccine at all, and it was just paying attention. For medical conditions, caller stated not really, unless Pfizer could reverse the aging process and fix macular degeneration. Caller stated he did not know if it was macular degeneration, there were no vision changes in his visual fields and his retinas are good. As he got older, he needed glasses. His vision changes might be due to age, he was not sure. The patient concomitant medications included insulin detemir (LEVEMIR) taken for diabetes mellitus from an unspecified start date and ongoing; losartan potassium (LOSARTAN POTASSIUM) taken for hypertension (blood pressure); omeprazole (OMEPRAZOLE ABBOTT) taken for gastrooesophageal reflux disease; (TOPIRAMATE ACCORD) and tramadol (TRAMADOL) taken for tremor from an unspecified start date and ongoing; metformin (METFORMIN); insulin (INSULIN) taken for diabetes mellitus, start and stop date were not reported; topiramate; atorvastatin (ATORVASTATIN); magnesium oxide (MAGNESIUM OXIDE); acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported. Patient had been Losartan Potassium on for like 7 years probably. Magnesium Oxide was given to patient with the heavy hitter dose, for to replace magnesium. He was not entirely up on that one tho. He had been taking for a year and a half. Aspirin regimen was given to make sure his blood stays good. They said he might as well because of his weight. Omeprazole was given for GERD, but he does not think that was what it was, he had to discuss it with his doctor. He had been on this for about 6 months. Caller stated no medications, just his Metformin, Atorvastatin, Insulin and his meds for diabetes and cholesterol. Levemir was 80 units but then brought down to 70 units 2 months ago because his sugars have been under control since losing weight. He spoke to his endocrinologist and reduced doses. Topiramate of 25 mg, 3 tablets BID so 75 in the morning, 75 in the evening and this is for tremors from the heavy water with Benzene and Tetrachloride and Carbon. He had been on it for about 2 years since he started getting really bad, but even with taking this stuff he still shakes. Caller did not see the Manufacturer on the bottle and did not confirm whether it was in pharmacy or manufacturer bottle when asked several times. Caller stated the NDC was 76282-0278-10 and it just said discard after 06APR2022. There was a patient sheet. He did not see manufacturer or any additional information, non-Pfizer product. Taking Tramadol Primidone 50 mg, 2 of them, for his tremors and started this on the same time as topiramate. Maybe it was 6 months, he was not really sure. The patient previously took flu shot and experienced vaccination site pain. The nurse comes and gives it to him. They just give him his flu vaccine, every 2 years pneumovax, and shingles he has not gotten around to that. Caller does not know additional information. Additional Vaccines Administered on Same Date of the Pfizer Suspect, prior Vaccinations (within 4 weeks), AEs following prior vaccinations, family medical history relevant to AE included none. The patient experienced malaise, tired, felt like, just tired, or tuckered out feeling at 17:30, soreness in his arm, injection site tenderness, kind of warm on 28Jan2021. Events did not require a visit to Emergency Room or Physician Office. Patient reported that he received both doses in February and all he had was a little general malaise, soreness in the arm but he gets that with the flu shot, and he was tired in the evening, but he thought that was because he was old. On 28Jan2021, around 16:30 to 17:00 hr, he had tenderness that was not really painful but just tenderness and kind of warm like when he gets the flu shot. Not bad or anything, just like when he gets the flu shot. At 17:30 hr, he started feeling more tired than he usually feels. He felt like mushad - if he was allowed to say that - just tired or tuckered out feeling. It was his left arm where it was injected and where he had the soreness. He always took it in his non-dominant arm. He woke up the next morning and was fine. The patient underwent lab tests and procedures which included electrocardiogram, magnetic resonance imaging with unknown results on an unspecified date. Caller does not provide additional information or whether or not he received this test due to his symptoms. They just did an MRI of his C-spine to see what is going on there to see if it is neurological or coming from the brain. Caller does not provide additional information or know specific test results as of yet. He was calling regarding whether he can get an additional series of vaccines because he had 2 doses and the federal government, and his state do not talk so he can go get another series and they will not know about it. Caller wanted to know if he can get another series of vaccines, so 4 instead of 2. Caller stated he was always happy to help and will file report. He stated sure there were minor side effects like injection site tenderness like with the flu shot. Caller stated those were not major side effects. Caller stated he was not calling to report, he was just asking about receiving a second set of inoculations. Clinical outcome of the events was recovered on 29Jan2021.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.