Sex: F
Vaccine: COVID19
Symptoms: Blood test, Headache, Investigation
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Acid Reflux" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "borderline diabetic" (unspecified if ongoing); "Surgery" (unspecified if ongoing), notes: The hypertension (Intent: Indication for Calan SR) was due to a surgery. Concomitant medication(s) included: CALAN [VERAPAMIL HYDROCHLORIDE] taken for hypertension (ongoing); CLONAZEPAM. Vaccination history included: BNT162b2 (DOSE 1, LOT# EL9265), administration date: 03Feb2021, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, the LOT# is FN6200), administration date: 24Feb2021, when the patient was 76-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3, the LOT# is FJ8757), administration date: 27Dec2021, when the patient was 77-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4, the LOT# R349), administration date: 21May2022, when the patient was 77-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Call was transferred from Pfizer Medical Information department (INT00896741). Transferring agent stated, "I do have a consumer on hold her name would be (Name withheld) last name (Name withheld). Product involved would be Calan and for the dosage this would be 2 dose so, originally the patient is taking 240 mg Calan SR but there is some issue in regards with the availability of that dose so, now she was given as an alternative to take the Calan 180 mg (Later consumer mentioned it as Calan SR 180 mg hence only Calan SR was captured as suspect).Then she provided me some reference number I am not sure if this is from your department BNT162B2 (Further reference# was not appropriately clarified). She said that she is receiving some envelops on mail (Hence report type was checked as Follow-up report in tab) requesting for her to send back her pills that was left but she mentioned that she did not report any uncommon adverse event in regards with her medication. So, she is requesting it to be stop and in addition with AE report earlier she also mentioned that she received all the Pfizer COVID-19 vaccine and she did not experience uncommon adverse effect aside from commons like headache but the formulation of COVID Vaccine was not verified (Event captured conservatively as per verbatim) and for her age that would be 78 years old female." Transferring agent stated, "Oh, I forgot to tell you the AE for these 2 dosages so, she mentioned that the (Calan SR) 240 mg gives her a lot of energy while this new one (Calan SR) 180 mg makes her a normal person (Event captured as per verbatim) that is what she described it and that is all the information I have. She is just requesting to mails to be stopped." When paraphrased the concern: Consumer stated, "There is a back order you guys have not produce it since Oct the 240 so I went to the doctor and now I taking the 180. I received 08Feb that I have COVID 19 and I never had COVID, never did and they wanted to know if I had all my shot and I had all my shot through Pfizer and my vaccination are also through Pfizer and I am fine." When probe to confirm if consumer want to stop receiving mails: Consumer stated, "Yes because it is not true, the only thing I wanted to know was when they were going to do the Pfizer 240 again? But I did spoke to my doctor and he started 180, I do like Pfizer." Consumer was informed that the entire request will be documented in this report and also to mention the concern and request in letter and send it back to Pfizer. Consumer stated, "Because it has all kind of date and questions and I am going like I never had this kind of problem." Consumer stated, "Let me write your name on the same letter that I spoke to you. Is there a reference number for you?" Consumer was provided with the reference number ##. Consumer stated, "Is there a number? Do you have a number to call? If they want to know you telephone number." Consumer was informed about the role of Pfizer Drug Safety. In response to further probing and when offered Pfizer Drug Safety contact#: Consumer stated, "Actually they should find it what I have in your name because I have you reference number so that should suffice them. I am assuming but I could be wrong because I have your Pfizer Safety Department." Consumer was provided with the number of Pfizer Drug Safety department as #, Option#1. Consumer stated, "Okay, I will do that." Consumer was informed about the role of Pfizer Drug Safety. In response to further probing: Consumer stated, "Yes, I thought when I first call the number and they transfer me to you they said if you like to take the survey stay on the line and you know so I was expecting someone to do that." In response to further probing: Consumer stated, "I do not have a problem with that. That is fine." Email Address: Consumer stated, "I do not have an Email Address." Reporter Type (If HCP): Consumer stated, "No, I am a retired university supervisor (Hence captured as consumer or other non health care professional)." Height and weight: Consumer stated, "Well, I shrunk (Further clarifications unknown) my height is exactly 4 ft. 10 inches. My weight is 140 (pounds) just had it done today from doctors two days ago." Other medical conditions and concomitant medications: Consumer stated, "The hypertension (Intent: Indication for Calan SR) was due to a surgery. That is why I take the medication (Calan SR). I take it (Calan SR) with 'Clonazepam' I take those 2 together. It does something to my arteries, so my blood cells go to my heart normally. It was from the surgery that had blocked my artery many years back, over 20 years. I do have stomach issues, I take medication (Further medication name was not clarified over the call) for acid reflux." Laboratory Tests: Consumer stated, "Actually yes, I just visited, I have an Oncologist because I do lose my iron and I get infusions of Iron but this time, I had visited the doctor. They just did my blood test but I have not got all my results but he said my white cells were little high. I am borderline diabetic (Intent: Medical Condition). I am about 80 years old (Further age was not appropriately clarified over the call)." -Name of Laboratory Tests: Consumer stated, "Actually, I am just eating correctly, I do not take medications for that (borderline diabetic). I control it (borderline diabetic) with my balance of my meal. I do not eat sugar, eat plenty of vegetables and I am okay." Product Details (Calan SR): -LOT#, Expiration date, NDC# and UPC# Consumer stated, "I am not taking the 240. I just renewed my 180. That has been a month now. So, it will be ready for me tomorrow. I do have it from (Name). It is Calan SR 180 mg. Manufacturer is Pfizer. What else do you need?" -LOT# and Expiration Date: Consumer stated, "Expiration date is 08Feb2024 (08Feb2024) but tomorrow I get a new prescription. So, it is probably about the same thing." -LOT#: Consumer stated, "I do not see a LOT# over that thing. I have never done all this. All I has this is take before that is it." -NDC#: Consumer stated, "Are you referring the prescription# of the pharmacy? I am not able to locate that. I have seen everything here. I do not have anything like that. It is just that do not crush, do not chew." LOT# (Pfizer COVID-19 Vaccine): Consumer stated, "No, I do not. I have to get my card. It was the last vaccination is that what you are referring to? Do you want it from the beginning to the end? Do you want all of them? The first one was 03Feb2021, LOT# EL9265. The next one was 24Feb21, the LOT# is FN6200 and all these are Pfizer by the way. The next one is 27Dec2021, the LOT# is FJ8757 and the next one is 21May2022 the LOT# R349 and it looks like 91 or 81 it is hard to read that one, next one is the vaccine and that 06Dec2023 and it does not give me LOT# there. That is the last one I got. (Further the date and month was not appropriately clarified over the call for the vaccination date)".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.