Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Headache, Migraine, Otic examination, Tinnitus
Clinical narrative: Ringing in the ears; When it gets really bad, it's like a migraine; headache got worse; This is a spontaneous reporter from a contactable nurse (patient). A 72-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) via an unspecified route of administration at upper left arm on 11Apr2021 around 09:00 (72-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included ongoing type 2 diabetes (Diagnosed 7 or 8 years ago), ongoing COPD (She doesn't remember when diagnosed.), ongoing Asthma (Diagnosed about 40 years ago), ongoing carpal tunnel bilateral (Diagnosed 2 to 2.5 years ago), ongoing back problem (Diagnosed about 10 years ago, but she is not sure), Trigeminal neuralgia (She doesn't remember when she was diagnosed. It comes and goes and she hasn't had for really long time. She hasn't had an episode of that for years and years. When it comes it is really bad for a couple days and then it goes away), ongoing heart condition (30 years ago she had silent heart attack. 19 or 20 years ago she had a blockage and they had to put a stent in. Still taking medication for it there is damage to her heart), silent heart attack (30 years ago), heart blockage (19 or 20 years ago), cardiac stent, migraine (once and it was like 40 years ago), and grief (She lost her husband). Concomitant medications included ongoing insulin degludec (TRESIBA) for type 2 diabetes (She started taking years ago. 5 years maybe); ongoing hydrochlorothiazide/valsartan (DIOVAN HCT) for cardiac stent (She started about 20 years ago. It's a blood pressure pill mixed in with a water pill); ongoing atorvastatin (LIPITOR) (Started taking 20 years ago); ongoing montelukast sodium (SINGULAIR) (She has been taking for over ten years); ongoing acetylsalicylic acid (ASPIRIN) for cardiac stent (She has been taking about 20 years); ongoing salbutamol (ALBUTEROL) for asthma and COPD (liquid for nebulizer/Inhaler. She has been taking for about 40 years. She doesn't take it all the time. She could go for a year without taking it); escitalopram oxalate (LEXAPRO) from 2020 and ongoing for grief. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FN6207) via an unspecified route of administration at upper left arm on 21Mar2021 at 8am (72-year-old at time of vaccination), at single dose, for COVID-19 immunization and experienced slight headache (Medically significant). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no adverse event following prior vaccinations. Patient took Pfizer vaccine back in March and she had a slight headache from it. Which everybody complains that she heard from, that they get a headache. Hers never went away. 11Apr2021 she had the second vaccine and headache got worse (Reporter seriousness: Disabling) at times on 11Apr2021 early in the evening around dinner time. To this day, she has not been without a headache for the last 10 weeks. She is very concerned. She went to her doctor. He did a CAT scan of the brain which showed no irregularities. She also has ringing in the ears which she doesn't know is a part of it or not. She went to see an Ear, Nose and Throat doctor. He said she needs to go see a neurologist for the headaches. She cannot get an appointment with the neurologist for two months. So, she is really concerned. She states the headache is mild at times and then it feels like someone is stabbing her in the head. She thought the ringing in ears had something to do with the headaches so she went to see the specialist for that, but he didn't say it was connected. He said there was nothing he could do for the ringing in the ears and that she needed to see neurologist for the headaches. Patient reports she got the headache the night she got the first shot. The headache got worse within hours of getting the second shot. When it is really bad it becomes really bad she cannot do anything. When it gets really bad, it's like a migraine. She has had a migraine once and it was like 40 years ago and she remembers how painful it was. With the one migraine, the room has to be dark and no noise and that is not the case now. The light and the noise don't bother her, it is just the pain. She states she has medical conditions, but she does not know how relevant they are. She has no problem with any part of her body that would give her headaches all the time. She states she needs some information as to what to expect from this. Has anybody else had this? Did it go away? She needs some answers. She need confirmation that she is going to be ok. All her family and friends got Moderna vaccine and didn't have this problem. She tried to get the Moderna. A friend of hers got her the appointment. She called and they said the Moderna was only for second dose. They only had the Pfizer. She was a little hesitant because everybody that got the Moderna was ok. As of now she has to tell people not to take the vaccine because of what happened. She doesn't want to live with this headache. Adverse events resulted in Physician Office visit. She gave it two months and kept thinking it was going to go away. It never did. Then she stated to get nervous. So, she went to him. Now she is petrified that it's not going to go away. Relevant Tests: Cat scan- no irregularities, examination of ears: they said they couldn't do anything for her. She worked as an LPN in acute care hospital for 35 years there and 5 in another. The outcome of the event headache got worse was not recovered; outcome of other events was unknown.; Sender's Comments: Based on chronological connection to the vaccine and known product safety profile a causal relationship between event headache exacerbation and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.