Sex: F
Vaccine: COVID19
Symptoms: Ear haemorrhage, Fall, Gait disturbance, Herpes virus infection, Influenza
Clinical narrative: dizzy; Small tumour found. Told it is in a super safe area of the brain; she now has a walker and she can't walk without it. Has problems balancing; she has a problem balancing; Bleeding in left ear was from herpes; Flu; So far she just has had bruises; test found the 8th cranial nerve/seriousness- have to say it's serious because the damage the 8th cranial nerve sustained is permanent; chronic vertigo; Falling/She seems to fall more when she bends over and stands up and if she is not holding on or tethered, she falls/Falling down; patient has ever had herpes, which she did in her left ear at that time/Herpes in left ear/has herpes sore on lip. Gets herpes on gums, throat, lips and ears; patient has ever had herpes, which she did in her left ear at that time/Herpes in left ear/has herpes sore on lip. Gets herpes on gums, throat, lips and ears; This is a spontaneous report received from a Nurse from medical information team.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "rectocele" (unspecified if ongoing), notes: Caller states years ago, she had a rectocele that was repaired twice; "rectocele repair" (unspecified if ongoing), notes: Caller states years ago, she had a rectocele that was repaired twice; "Obese" (ongoing); "diabetes type 2" (ongoing), notes: diabetes type 2 diagnosed in her 30's.; "Knee replacement", start date: 2008 (unspecified if ongoing), notes: she had a knee replacement in the past, bilateral knee repair, 2 knee replacements; "Surgical menopause" (unspecified if ongoing), notes: Has also went through surgical menopause a long time ago; "scoliosis" (unspecified if ongoing); "Hypertension" (ongoing), notes: Hypertension Diagnosed about 10 years.; "Chicken pox" (unspecified if ongoing), notes: She had chicken pox as kid.; "incest survivor" (unspecified if ongoing), notes: States she is an incest survivor and that is why she has herpes in her throat.; "insomnia" (unspecified if ongoing), notes: she had insomnia. Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus (ongoing); LISINOPRIL taken for hypertension (ongoing); HYDROCHLOROTHIAZIDE (ongoing); BENADRYL taken for insomnia. Vaccination history included: Bnt162b2 nos (Dose, 1 single), for COVID-19 immunization, reaction(s): "Falling", "chronic vertigo"; Shingrix (Dose number: Unknown, Manufacturer: Unknown, had she not had the Shingrix vaccine, she would have bells palsy and the Shingrix stopped it from being bells palsy), for immunisation. The following information was reported: FALL (medically significant) with onset Oct2022, outcome "not recovered", described as "Falling/She seems to fall more when she bends over and stands up and if she is not holding on or tethered, she falls/Falling down"; HERPES VIRUS INFECTION (non-serious), ORAL HERPES (non-serious) all with onset Oct2022, outcome "unknown" and all described as "patient has ever had herpes, which she did in her left ear at that time/Herpes in left ear/has herpes sore on lip. Gets herpes on gums, throat, lips and ears"; NERVE INJURY (medically significant), outcome "unknown", described as "test found the 8th cranial nerve/seriousness- have to say it's serious because the damage the 8th cranial nerve sustained is permanent"; VERTIGO (medically significant), outcome "not recovered", described as "chronic vertigo"; DIZZINESS (medically significant), outcome "not recovered", described as "dizzy"; BRAIN NEOPLASM (medically significant), outcome "unknown", described as "Small tumour found. Told it is in a super safe area of the brain"; GAIT DISTURBANCE (disability), outcome "unknown", described as "she now has a walker and she can't walk without it. Has problems balancing"; BALANCE DISORDER (disability), outcome "unknown", described as "she has a problem balancing"; EAR HAEMORRHAGE (non-serious), outcome "unknown", described as "Bleeding in left ear was from herpes"; INFLUENZA (non-serious), outcome "unknown", described as "Flu"; CONTUSION (non-serious), outcome "unknown", described as "So far she just has had bruises". The patient underwent the following laboratory tests and procedures: Bone densitometry: Unknown results, notes: make sure she doesn't break bones; Test: 8th cranial nerve; Magnetic resonance imaging: small tumor found, notes: Told it is in a super safe area of the brain.  Clinical Information: Patient states that she has chronic vertigo that occurred after receiving 2 injections of the Pfizer COVID vaccine. Caller states "it went up into her brain stem, effecting her cranial nerve, and now she has a walker and can't walk without it as she has a problem balancing." Caller stated that she "has been falling lately and she can't help it." Caller stated she "received 2 injections subsequent to that and stated "not to say that is because of that, they traced it to her cranial nerves." Caller stated that she was told "some studies provided if you've ever had herpes, which she did in her ear at the time, as she was bleeding out of her left ear, that it might be related to the vaccine, but it also may not be. There is no study to show us." Caller provided "had she not had the Shingrix vaccine, she would have bell's palsy and the Shingrix stopped it from being bell's palsy. Patient mentioned that received 2 doses of Pfizer COVID vaccine, and she reports she has chronic vertigo that happened after receiving the injections. States she now has a walker and she can't walk without it. Has problems balancing and has been falling lately. Did state they stated they are not sure if because of the vaccines but not ruling it out either. States they traced it to the 8th cranial nerve and the doctor provided some studies that have provided if the patient has ever had herpes, which she did in her left ear at that time, it may be related to the vaccine. States she was bleeding out of her left ear during this time. She has a chronic condition but doesn't blame anyone except maybe the (name withheld). She is not mad. Reporter Details: in 1977 came out of practical nursing school and retired in the 80's. The vaccine came out in 2021 she is thinking. When did 1st iteration come out? She was 71 when she had the vaccine. She messed around for about a year and vertigo got worse and worse before they got to bottom of it. She had to get pretty ugly because she was getting blown off, because she is on blood pressure medications and as an old lady gets dizzy. Dates of vaccine - she was in first bunch when the came out because of her age. Does not have dates to provide. Doesn't have NDC, lot or expiry to provide. She has her card in her purse in another room. Vertigo started several weeks after the 2nd dose. Noticed it in morning when got up and make tea. The microwave sits on top of the refrigerator. She made poached eggs and tea and was reaching up. After looking upwards would start to be dizzy. Didn't think much about it. Saw doctor she had at that time. When you are 73 people give you brush off and say you're on blood pressure medication. States she was not falling down yet outcome was persisting. seriousness: quite serious because she never knows when it will hit. Has safeguards in place. At head of basement steps she has a tree climber belt and security bar so no one kicks in door fastened into stud. When she does cat litter box she puts belt on her waste. She seems to fall more when she bends over and stands up and if she is not holding on or tethered, she falls. She has done all the tests like MRI (Magnetic resonance imaging) and is getting a Dexa scan to make sure she doesn't break bones. Had a test that has a really long name and that test found the 8th cranial nerve. She is a prepper and raises tilapia in her basement in pools and if she faints and falls into the pool she will drown. The slides get slick. She has to tether herself to a clothesline and will still fall but not so far. Her doctor likes the idea that she does that. She also has walkers on every floor and uses a transfer bench to shower. She has had 2 knee replacements and if she is on the ground she can't get up because if you don't have the core strength it's impossible. Falling down started last fall, Oct2023, so a year before that in Oct2022. Her first bad fall was Oct2022. outcome - persisting, she just uses more care seriousness: won't go to hospital because they can't do anything. Most people would call. She had to call life squad and get rescued her 1st fall. She knows nothing to go to hospital about because it's not curable. Herpes in left ear was at time of first fall around Oct2022. outcome: it's like 3 S trigger. For years didn't have anything. Now sunlight, sickness and stress cause flareups. Had Flu at Christmas time and has herpes sore on lip. Gets herpes on gums, throat, lips and ears. She has always had herpes but not in her ear. That was after the vaccine. Never had in her ear until after vaccine. That is why they said one study they heard about it wakes up and makes herpes wake up and be more virulent that could explain why it's in the ear now and not before. May be and may not be true. seriousness- have to say it's serious because the damage the 8th cranial nerve sustained is permanent. If it was going to travel to inner ear. Thinks 8th and 10th cranial wind around each other and if just flared up and went away and wasn't dizzy would say not so serious. If goes into same nerve again may not walk again. Bleeding in left ear was from herpes. Didn't know that at first. She woke up with bloody pillow. That is what they thought it was. She is upset, she doesn't like way they give shots now and why she didn't want to get it. When she was taught to give you insert, pulled back on plunger, observe barrel and check if in a vein. She only got blood back twice in thousands she gave. They weren't doing old school way and just withheld in and if it's in a vein oh well. Concomitant Medication: no, she got a little bad habit of if she had insomnia and not asleep by midnight she would take Benadryl 25mg to make her sleepy. She quit taking it. Her doctor said maybe that is why issues with inner ear because she was not taking antihistamine anymore. Investigations: she can't think of the name of the test that identifies the nerve involved. She lay on a table and they blow cold and hot air, the hot air burns like fire. They give you a letter and say what words begin with that letter. She wasn't expecting to talk about this, she was calling to find out about Estring because of falling and the Dexa scan. How likely with falls going on to break bones. So far she just has had bruises. She missed the piano by 6 inches last time. That was scary. She had her walker but goofy cat had the ring that comes off after opening vitamins and she chews and swallows and chokes. She was doing that and caller got up intent on keeping her from choking and didn't grab her walker and went down. It's on her, she has to get used to it. She has to get her walker and tethered.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on information in the case the causal relation between the reported events Nerve  Injury, Vertigo, Dizziness, Brain Neoplasm, Gait disturbance , balance disorder and the suspect drug cannot be excluded. Fall is likely due to the underlying condition of Vertigo/balance disorder and not in relation to the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.