Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: breaking into shivers like she was at the north pole and she could not get warm, it was like an internal earthquake; breaking into shivers like she was at the north pole and she could not get warm, it was like an internal earthquake; Then the heat turned on; for 4 hours she was burning up and sweating; Then the heat turned on; for 4 hours she was burning up and sweating; extremely tired; her arm hurts; had a headache that she had never had before unlike any other; nauseated/nausea; flu like discomfort; 4 hours like scarlet fever; Upset stomach; Weak; 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.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 79 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 06Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "blood pressure" (ongoing), notes: I take blood pressure pill (Losartan); "I am over weight" (unspecified if ongoing); "reflux" (unspecified if ongoing), notes: something for reflux, Omeprazole. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal; OMEPRAZOLE taken for gastrooesophageal reflux disease. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot#: EN6202), administration date: 28Feb2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "a little fatigue", "her arm was sore"; BNT162b2 (DOSE 2, SINGLE, Lot#: EN6206), administration date: 21Mar2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "a little fatigue", "her arm was sore"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot#: 3012SBA), administration date: 07Oct2021, when the patient was 78-year-old, for COVID-19 immunization, reaction(s): "breaking into shivers like she was at the north pole and she could not get warm, it was like an internal earthquake", "breaking into shivers like she was at the north pole and she could not get warm, it was like an internal earthquake", "Then the heat turned on; for 4 hours she was burning up and sweating", "Then the heat turned on; for 4 hours she was burning up and sweating", "extremely tired", "her arm hurts/soreness in the arm", "had a headache that she had never had before unlike any other", "Nauseated", "flu like discomfort", "suffered upset stomach", "Weak"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 18May2022, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "breaking into shivers like she was at the north pole and she could not get warm, it was like an internal earthquake", "breaking into shivers like she was at the north pole and she could not get warm, it was like an internal earthquake", "Then the heat turned on; for 4 hours she was burning up and sweating", "Then the heat turned on; for 4 hours she was burning up and sweating", "extremely tired", "her arm hurts/soreness in the arm", "had a headache that she had never had before unlike any other", "Nauseated", "flu like discomfort", "4 hours like scarlet fever", "Upset stomach", "I would be weak". The following information was reported: CHILLS (non-serious), outcome "recovering", FEELING COLD (non-serious), outcome "unknown" and all described as "breaking into shivers like she was at the north pole and she could not get warm, it was like an internal earthquake"; BURNING SENSATION (non-serious), HYPERHIDROSIS (non-serious), outcome "unknown" and all described as "Then the heat turned on; for 4 hours she was burning up and sweating"; FATIGUE (non-serious), outcome "unknown", described as "extremely tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm hurts"; HEADACHE (non-serious), outcome "recovering", described as "had a headache that she had never had before unlike any other"; NAUSEA (non-serious), outcome "unknown", described as "nauseated/nausea"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like discomfort"; SCARLET FEVER (non-serious), outcome "unknown", described as "4 hours like scarlet fever"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Upset stomach"; ASTHENIA (non-serious), outcome "unknown", described as "Weak". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, nausea.  Additional information: The consumer stated she already reported all of this and provided all the information regarding numbers (lot numbers) for each vaccine this to the previous agent; e-transmitting potential duplicate/additional AE details. The consumer stated she had taken all the Pfizer Covid vaccine shots, the primary and all the boosters. She stated it had been about 5 months since her last booster dose. She stated she was the only one her age that had her age that had the reactions she did, and she read in the fact sheets, and it said, "mild symptoms" and she does not think her symptoms were mild. Because of her reaction she was reluctant to take the next dose and wanted someone to tell her, but the CDC and the doctors do not help. She stated she received the first two shots, no problem, the only major thing was a little fatigue, and her arm was sore. She stated "The booster dose, problem" - She got the vaccine at noon and went and ran errands and at 10:00 she started breaking into shivers like she was at the north pole, and she could not get warm, it was like an internal earthquake. Then the heat turned on; for 4 hours she was burning up and sweating. The next day the shivers and heat subsided, and she was extremely tired and of course her arm hurt, it always hurts after. She had a headache that she had never had before unlike any other. She was also nauseated. Her headache subsided after she took Tylenol. The flu like discomfort lasted about a week.  The next time (next booster dose)- she got the vaccine at noon, ran errands and at 10:00 almost to the point it all happened again. The third time (next booster dose)- it happened again. She stated she does not consider 4 hours of shivering mild, 4 hours like scarlet fever. She had a healthy body. For her body to go into that state seemed rather extreme. She had read that fact sheet and all she was getting was "okay thanks, for nothing. I wish some people at Pfizer would be like here are more severe side effects that may occur." After providing that there were some more severe side effects listed like allergic reactions, she stated she did not see that in the fact sheet. The consumer stated she already reported this and provided the previous agent with all the numbers for each vaccine and all the information regarding this.  The consumer wanted to know if she should receive the next booster after all of this? She wanted someone to tell her whether these side effects were more than "mild." She wanted to know who could determine this for her? She doesn't know if there was a long-term side effect or what it is doing to her body. The consumer stated, "I had all my initial shots and all the boosters, and I am 80 years old, so I think it's now time I should get another one they say you get another one, right? You keep getting them if you are 80 but or do you stop getting them?" The consumer stated, "Okay, well now am I supposed to report that I have felt like I had adverse symptoms to this department? Because that's determining whether I want to take next one or not, for the last few shots I did know I have read all the reports about the you have suffered a mild symptoms, I don't think my symptoms were mild, the first time I didn't notice it was going to happen, so the second, third time okay I thought I will be prepared with food and suffered upset stomach because the three time, 10 hours after I got the shot almost to the minute because I got the shot at noon and I go about doing my business and everything that happened at the time of shot was the soreness in the arm but at 10 o'clock that night for 3 times I would break out in the chills, I mean really bad chills like I was suffering from some disease and I would last about 4 hours, then the chills would stop and I would go in to sweat like a fever in sweat for another 4 hours, so then those with the side and I would be weak and nauseated and I have never had headache, I am in good condition, my vitals were good, I am over weight other than that I take blood pressure pill (Losartan) and something for reflux, Omeprazole and those are really 2 prescription I take for an 80 year old pretty good. Anyway for entire week I was just no good, I am 'disreg' I don't consider, and then my friend through my age or little younger ones my age, the only symptoms they I have is soreness in the arm, now I have read that people say well it just means the shot is working, well it's having a hell of war with me so they must be working damn good to put me out for a week, I am wondering the next shot if I should take it if you understand because that is a week of my body going through (Incomplete sentence)." Anatomical Location of Injection: Consumer stated, In the arm or shoulder, the part above my elbow." Other Medical Conditions or Other Medications: Consumer stated, "For blood pressure Losartan and Omeprazole, well I take a bunch of Vitamin supplements." Prior Vaccination (within 4 weeks): Consumer stated, "The last vaccine I took a flu shot at the same time, I put my cards away but over the last day for the COVID vaccination which one I had the flu shot. Date for Flu Shot: Consumer stated, "The day of the last COVID vaccine I gave you, I put the cards away." Treatment: Consumer stated, "Tylenol and something for nausea but I don't remember I had chewable, Tums I think."; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300214238 same patient, different drug, dose and event;