Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, International normalised ratio, Investigation, Lymphadenopathy, Migraine
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 65-year-old female patient received BNT162b2 (BNT162B2), on 05Jul2022 as dose 4 (booster), single (Lot number: FP7H39) at the age of 65 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Fibromuscular dysplasia", start date: 2013 (unspecified if ongoing); "I kind of get migraine headaches" (unspecified if ongoing), notes: I kind of get migraine headaches but usually I take a medicine caller Ubrelvy.; "I also had 2 lumpectomy this last fall" (unspecified if ongoing), notes: stage zero breast cancer.; "Interchange of vaccine product" (unspecified if ongoing); "dissections in few of my arteries" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for fibromuscular dysplasia, start date: 2013 (ongoing); UBRELVY taken for migraine. Vaccination history included: Moderna covid-19 vaccine (Dose 1), for Covid-19 immunization; Moderna covid-19 vaccine (Dose: 2nd), for Covid-19 immunization; Bnt162b2 (Dose:3rd. a Pfizer (Later clarified as Pfizer COVID-19 Vaccine) in Dec and then 4th injection of Pfizer 05Jul.), administration date: Dec2021, when the patient was 65 years old, for Covid-19 immunization. The following information was reported: BODY HEIGHT DECREASED (non-serious) with onset 06Jul2022, outcome "unknown", described as "5'4, I just found out, I shrunk so 5'3 inches"; FEELING ABNORMAL (non-serious) with onset 06Jul2022, outcome "unknown", described as "I am just been miserable"; AGITATION (non-serious) with onset 06Jul2022, outcome "unknown", described as "I get a little flustered because of my headache is so intense"; MIGRAINE (non-serious) with onset 06Jul2022, outcome "unknown", described as "Migraines"; LYMPHADENOPATHY (non-serious) with onset 06Jul2022, outcome "unknown", described as "a really swollen lymph node on the same side of the injection site"; PAIN IN EXTREMITY (non-serious) with onset 06Jul2022, outcome "unknown", described as "barely had pain in my arm"; HEADACHE (non-serious) with onset 06Jul2022, outcome "unknown", described as "excruciating headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache. Additional information: Consumer stated, "I am very concerned and I am seeing my headache doctor, he is neurologist but he suggested that I go ahead and call the Pfizer line. My situation is, I am 65 years old and I have had 2 Moderna (Further not clarified hence suspect captured as Unspecified Vaccine) on schedule and a Pfizer (Later clarified as Pfizer COVID-19 Vaccine) in Dec and then my 4th injection of Pfizer 05Jul. Then starting 06Jul, I started getting a headache and my reaction to the vaccine was very mild and I barely had pain in my arm, I did not feel tired at all. I had an excruciating headache ever since 06Jul so that is 17th days ago, so we have tried all, we have tried my normal headache medicine which is called Ubrelvy, we have tried the new ones and nothing is cutting it. My doctor feels that it is an adverse reaction to the (Incomplete sentence). I have not had nothing, I do not have any stress in my life. I had nothing everything was perfect and then I got this 4th booster and I am just been miserable so he felt I needed to report this adverse reaction." Consumer stated, "Yes, and it was 05Jul that I got the injection and then it was just 6th when my symptoms started. I just want to make sure you got have that right. Then my doctor also wondered, if is it common to go almost 3 weeks with the headache and suggestions." Consumer was informed about the role of Pfizer Drug Safety department. Consumer was informed about the Pfizer Medical Information Department for the concern.  Consumer stated, "I got all 4 vaccines, 2 Moderna and 2 Pfizer at (Pharmacy name-withheld). I think for all of them I got it on my left arm, like upper part of my left arm." Consumer stated, "Actually I have to take this back, I am really sorry. I get a little flustered because of my headache is so intense (Event captured as per verbatim) so I will leave that up. I also had 2 lumpectomy this last fall, stage zero breast cancer. I do not think it is related to my headache. I also have a condition that was diagnosed in 2013 called Fibromuscular dysplasia, it is abbreviated FMD and the reason I am mentioning that because it has to do with dissections in few of my arteries, so I have to take Warfarin for that. That is why I am mentioning that and I have taken Warfarin since 2013." Consumer stated, "Yes, blood test for what though? Well for one I checked my INR every two weeks, you know what I am talking about with INR? I have a home kit to check my INR every two weeks until we try to maintain about 2.5 (Further not clarified) and then I just had for different reasons with my gastroenterologist. I just had some general blood work done and I was called and it was all normal, so I do not have list of what was tested, actually no they also did a test for a cancer antigen and everything came back normal." Consumer stated, "Yes it is and Allergan product and it is new it is very expensive, it is called Ubrelvy 100 mg, and the drug on that is called Ubrogepant, Ubrelvy is the trade name (Later clarified that patient was taking Ubrelvy hence captured as suspect conservatively)."  LOT# (Ubrelvy): Consumer stated, "I have different you know. The way I get this medicine as my doctor gives me samples because it is very expensive on papers. The reason I get it up because some are expiring in Dec and some are expiring in Sep so they all have different LOT numbers." Prior vaccinations (4 weeks): Consumer stated, "No. not at all. I do not get flu shots, I never had the pneumonia shot so no." It was reported that female, aged 65 (DOB: (Date of birth-withheld)) took her fourth dose (second booster) of the Pfizer BioNTech Covid 19 vaccine on 05Jul2022. She woke up on 06Jul2022 with a headache and a really swollen lymph node on the same side of the injection site. She does see a neurologist for migraines but this is nothing like that. This is nothing like that. Migraines usually come with an aura, its not like that at all. She takes Ubrelvi for it. She read online that side effects usually last 3 to 8 days, this is day 19. Its been excruciating. She has had a headache for 19 days. She saw online that there have been reports of cerebral clots. Is there any information on headaches.