Age: 73.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Insomnia, Myalgia, Nausea, Restless legs syndrome, Tremor
Clinical narrative: Sick; Nausea; Insomnia; Shaking; Throwing up; Tongue reaction; Hurts a little bit you know at point of injection; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 13Sep2024 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 1 diabetic" (ongoing). Concomitant medication(s) included: INSULIN [INSULIN NOS] taken for type 1 diabetes mellitus. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EM9810), administration date: 06Feb2021, for COVID-19 immunization, reaction(s): "it hurts a little bit you know at point of injection"; BNT162b2 (DOSE 2, SINGLE, Lot: EL9266), administration date: 28Feb2021, for COVID-19 immunization, reaction(s): "it hurts a little bit you know at point of injection"; BNT162b2 (DOSE 3, (BOOSTER) SINGLE, Lot: FF8841), administration date: 01Oct2021, for COVID-19 immunization, reaction(s): "it hurts a little bit you know at point of injection"; BNT162b2 (DOSE 4, (BOOSTER) SINGLE, Lot: FK9893), administration date: 07Apr2022, for COVID-19 immunization, reaction(s): "it hurts a little bit you know at point of injection"; BNT162b2 (DOSE 5, (BOOSTER) SINGLE), administration date: 06Aug2022, for COVID-19 immunization, reaction(s): "it hurts a little bit you know at point of injection"; BNT162b2 (DOSE 6, (BOOSTER) SINGLE, it says Pfizer 'Bvilin', something like that), administration date: 16Aug2022, for COVID-19 immunization, reaction(s): "it hurts a little bit you know at point of injection"; Moderna (DOSE 7, (BOOSTER) SINGLE), administration date: 2022; Flu vaccine (just like the flu vaccine I take every year). The following information was reported: INSOMNIA (non-serious) with onset 14Sep2024 at 03:00, outcome "recovering"; NAUSEA (non-serious) with onset 14Sep2024 at 03:00, outcome "recovering"; TREMOR (non-serious) with onset 14Sep2024 at 03:00, outcome "recovering", described as "Shaking"; VOMITING (non-serious) with onset 14Sep2024 at 03:00, outcome "recovering", described as "Throwing up"; VACCINATION SITE PAIN (non-serious) with onset Sep2024, outcome "unknown", described as "Hurts a little bit you know at point of injection"; TONGUE DISORDER (non-serious) with onset Sep2024, 2 days 13 hrs after the suspect product(s) administration, outcome "not recovered", described as "Tongue reaction"; ILLNESS (non-serious) with onset 16Sep2024, outcome "unknown", described as "Sick". The patient underwent the following laboratory tests and procedures: Full blood count: Unknown Results.  Patient took the vaccine around 11 am on Friday, the 13Sep2024 and around 3 am he got such an adverse reaction that honestly, first of all he will never take another Covid vaccine again. Nothing against Pfizer because after that point he heard about 6-7 Covid vaccine, all of them would exception of one were Pfizer and the last one he took couple years ago was Moderna because then they hadn't Pfizer. He never had any adverse reaction for those five or six first Pfizer vaccine. He had a severe reaction with the Moderna vaccine, he took, he believe, in his opinion 2022 sometime, maybe the fall of 2022. However, this vaccine he took, the covid vaccine he had from Pfizer, it was like having the most severe, you know, between nausea, insomnia, shaking, throwing up and so forth, he just can't describe it. He made promise to himself that he will never again. He would rather die  of covid than take another vaccine, it starts the reaction he was going to have because he knew about pharmaceuticals. He worked for another pharmaceutical company and he was only calling like to inform that it, he was not be the only person on the face of the earth.  He did not believe so but this was the worst adverse reaction he had on any vaccination or any medical interventions he had in his life. When he said he wised he was dead, he meant that and he did not say that he was 74 years old and he was very tolerate to a lot of stuff and due to past experiences but this vaccination. When they advertise about the vaccine, Pfizer advertises, Moderna advertises about the new vaccine and it's been push like, nobody was talking about some possible adverse reactions that really are unheard of. Patient stated on Monday almost four days later and he was still felling tongue reaction is upside a little bit but that's fighting really did not start, maybe yesterday, let's say afternoon but he started feeling a human again. The worst was Saturday morning and all Saturday and Sunday morning it was unbearable. It was really was unbearable. Patient stated that he was not trying to point the finger as a matter of fact because he had several vaccination for Covid. As a matter of fact it had started where he was before and he tried to be ahead of the game and took several vaccinations. So, as  he said, the first 4 or 5 no problem, he did not even had a local pain injection, no problem whatsoever, just like the flu vaccine he took every year. Now, last time he took a Moderna vaccine because  they did not have the Pfizer which he preferred, that gave him a quite a bit of a reaction but nothing like this latest one, it was a Pfizer vaccine for the Covid-19. He just wanted to report in, just in case this others or he meant, he was pretty sure that Pfizer wants to know severe adverse reaction to their, he mean something like it hurts a little bit you know at point of injection. He can understand but this was something that and as he said to you he was very tolerate to a lot of things, surgeries and injections and so forth. This has been the worst adverse reaction he ever had in his life. Patient was informed about the role of Pfizer Drug Safety Department. Patient stated that he can tell a little bit more information about his address and where the injection was done, the grocery store pharmacy. There were two places here. He cannot exactly remember now the exact location but it was one of the two locations, pharmacies. When probed again for the reason of taking the vaccine, consumer stated that he tried to be proactive He had underlying medical conditions that, according to the CBC, probably, should be going and getting just like the any other vaccine like the flu vaccine and so forth. It was his personal decision to make and he did not get it and then pushed or anything like that. He knew that his son and his daughter-in-law, they got it pretty heavenly but about a week and a half they went and so he did not know, maybe that had something to do with him, he decided to take it but he would not take it if he was, if he knew like, the after effects, okay. Patient states that he was  type 1 diabetic and I am talking a 'slew' of, he did not have the time to write down my everybody. Obviously, he was taking insulin, long time and short time insulin. The patient did not have any blood work in past two weeks. Patient took Moderna and Pfizer vaccines. For Pfizer vaccine, he had a  ecord only of a vaccine by Pfizer that he took back in on 16Aug2022 and it says Pfizer 'Bvilin', something like that, and he did not understand that. When probed if the consumer was not able to provide details for previous dosage, consumer stated that he took pictures of the card they usually,  before the vaccine was, when covid was first came, it was very strong. People were dying by the thousands. The first vaccine that he took was the Pfizer vaccine, EM9810, if that means something. When probed if EM9810 is the lot number, consumer stated that he did not know, probably. He mean that show means something that referred on him. He thought that was the lot, EM9810 and that first vaccine was on 06Feb2021. The second vaccine he took was, again the lot number for that one was EL9266 and it was on 28Feb2021. So, within a month he took 2 of those Pfizer vaccines. Patient stated that he still had one more, it was administered on Oct2021, that was Pfizer vaccine, Lot FF8841 and that was on 21Oct. He was going to make a guess but it was in 01Oct2021. Another one that he had a record of was Pfizer vaccine he only had the Lot and  he did not have when it was administered but the Lot was FK9893 and that was administered if 07Apr2022. He had another one here that was administered on 06Aug2022, he thought and it was a Pfizer vaccine and unfortunate he did not have the Lot on this one.  He did not have a record of the Lot on this one. That's all he can give.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.