Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal, Tinnitus, Vaccination site inflammation, Weight
Clinical narrative: Interchange of vaccine products; the ringing started again; Disease recurrence; My head was hurting; Because of this buzzing I have sometimes hard time understanding and hearing; it does inflame my arm a bit.; can't think easily; This is a spontaneous report received from a Nurse from medical information team.  A 78-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE; SYNTHROID. The patient also took other concomitant therapy. Past drug history included: Fexofenadine hydrochloride for Allergies, notes: 180 milligrams daily, basically Allegra formula. Vaccination history included: moderna (DOSE 1, SINGLE, lot: 029K2OA), administration date: 27Jan2021, when the patient was 75-year-old, for covid-19 immunisation; moderna (DOSE 2, SINGLE, lot: 002A21A), administration date: 24Feb2021, when the patient was 75-year-old, for covid-19 immunisation; moderna (DOSE 3 (BOOSTER), SINGLE, lot: 017F21A), administration date: 25Oct2021, when the patient was 76-year-old, for covid-19 immunisation; moderna (DOSE 4 (BOOSTER), SINGLE, lot: 001MD1A), administration date: 22Apr2022, when the patient was 77-year-old, for covid-19 immunisation; Bnt162b5;bnt162b5 omi ba.4-5 (fist Pfizer dose), administration date: Oct2022, when the patient was 77 years old, for covid-19 immunisation, reaction(s): "Thinking abnormal", "Vaccination site inflammation", "Ringing in ears"; Flu vaccine, for immunisation; Moderna (DOSE 5 (BOOSTER), SINGLE), when the patient was 77 years old, for covid-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown", described as "the ringing started again"; DISEASE RECURRENCE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "My head was hurting"; HYPOACUSIS (non-serious), outcome "unknown", described as "Because of this buzzing I have sometimes hard time understanding and hearing"; VACCINATION SITE INFLAMMATION (non-serious), outcome "unknown", described as "it does inflame my arm a bit."; THINKING ABNORMAL (non-serious), outcome "unknown", described as "can't think easily". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: The patient received all the Moderna Covid vaccinations until 2022 and had a Pfizer Covid booster which left she with constant ringing in her ears. It started almost immediately and continues. At times when the room is quiet, it is so loud that she can't think easily. Oct of 2022 she received the Pfizer booster and the flu shot. and immediately she noticed all this noise. It's like a buzzing in her ear. Over the year, it got a little better. In 2023, got the flu shot and the Pfizer booster and the ringing started again. Today, it was really bad when she got up. Her head was hurting. She took 1 Tylenol and 2 ibuprofen this morning and it's helped, but the ringing is still there. She discussed this with 2 different doctors. One doctor said she's read about it and it could be the COVID vaccine. The doctors didn't know what to tell her to do for it. Because of this buzzing, she has sometimes hard time understanding and hearing correctly. LOT#: Consumer stated, "It says Pfizer. I can't read it, JIBA looks like a GJ2J26, but I don't know. I am reading just somebody wrote down. I don't know and as far I got last for they would not, they said I did not need to write it down. So, I did not write it down. They did not write it down because I have my card that I take every time that I have gotten two Moderna's for COVID."  That is an spironolactone pill per day saving medication. When probed if the consumer took any vaccine 4 week prior with the reference of Pfizer COVID-19 Vaccine: Consumer stated, "I have not had any COVID since last, what I told what it was October the 3rd, 2023 was the last COVID booster I had. Actually she is Retired Nurse. She is calling about herself and she is reporting an adverse event with Pfizer COVID-19 Vaccine (Later clarified). She received the Pfizer COVID-19 Vaccine in October of 2022 and along with the Flu Vaccine and she experience ringing in the ears and in 2023 she got the latest Pfizer COVID-19 Vaccine Booster and the flu shot again and the ringing started again and she still has the ringing. The one that started the ringing in the ears or the first one. She got Moderna, all the one I got previously the 2022 were Moderna. Then 2022 October she got a Pfizer and then at the end of September of 2023, she got a Pfizer. They were boosters. All she know is that they were senior's Flu shots (Unspecified Flu shot). The shot that they gave to anybody over 65, she think. They are stronger the stronger flu shot." That was what she was reading it also, it was just the card they gave us a vaccination record card that the CDC started with and I had all my doses for 2nd, 3rd, 4th, 5th and then the 2 Pfizer ones and like she said. She don't have any more then she gave. That's all she has. After second dose she had my another one she don't understand this one it says it was 24Feb2021. It was September 29th, 22 on pharmacy/drug store was the first Pfizer and it says Pfizer and looks like JIBA. All she had got advertisement that it is extend All I have got is GJ2J26. That's what it looks like, somebody handwritten in it. That was all she had got. She don't know if that's it, it's says OTRA, then it says GJ2J26. That's what it looks like and so I don't have any and then that one I has just pass October 3rd 23. They told her, they did not have to write it down. So, she just wrote the date down Pfizer, and Ishedon't have a LOT number any other number with that. It was booster and I was told that you can mix the Moderna and the Pfizer that they did not make any difference. Imagine it was a left arm. she hardly ever, she was right-handed, so she trid not to because I realize that it does inflame my arm a bit. So, she made it sore, so she usually always get it in left arm. Concomitant medication: Yes. She took a generic Synthroid for that, one pill daily. Let she got the doses for you and she took one other besides over the counter because she did have allergies (History). So, she did take over the counter medication too. The was Synthroid Levothyroxine (Not further clarified hence not captured in tab). She took 112 micromilligrams tablet per day. Treatment: Consumer stated, "For my allergies, I took 5 years of shot and this is all prior to be getting, that's several years ago. I finished those. I took those for 5 years. Two shots every 4 weeks against thing that I was allergic to again I also take a generic Allegra, which is one tablet daily." Take Fexofenadine Hydrochloride and 180 milligrams daily. It's basically Allegra formula, the Allegra brand formula. Allegra which is one get it to her  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400018338 same patient, different dose and event;