Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Somnolence, Vaccination site discomfort, Vomiting
Clinical narrative: Arthritis has been it almost like it flared up more; Vomiting; my stomach is really upset; Stomach was sick; I had digestion really not good for like almost like burning/Very bad Heartburn; Very tired / Very dragged out; Weak; Body aches; Fall asleep; it feels like it is on the left arm where I got the shot, it feels like I have like a nylon sleeve on my arm like all of the sudden there is something on my arm; Gets worse with the back pain; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: Osteoporosis; "arthritis" (ongoing); "went through COVID" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2022, for COVID-19 immunization, reaction(s): "fall asleep", "Feels like I have like a nylon sleeve on my arm; There is something on my arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "Flu-like symptoms"; Bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE; shot was probably a year ago or the last fall), administration date: 2023, for COVID-19 immunization, reaction(s): "it felt like there was a nylon sleeve on my forearm / it happened again like the last time"; Flu shot (regular flu shot; get them every year), for Immunization, reaction(s): "never got a reaction". The following information was reported: VOMITING (non-serious) with onset 02Oct2024 at 05:00, outcome "unknown"; PAIN (non-serious) with onset Oct2024, outcome "recovering", described as "Body aches"; SOMNOLENCE (non-serious) with onset Oct2024, outcome "unknown", described as "Fall asleep"; BACK PAIN (non-serious) with onset Oct2024, outcome "unknown", described as "Gets worse with the back pain"; DYSPEPSIA (non-serious) with onset Oct2024, outcome "recovered" (Oct2024), described as "I had digestion really not good for like almost like burning/Very bad Heartburn"; FATIGUE (non-serious) with onset Oct2024, outcome "unknown", described as "Very tired / Very dragged out"; ASTHENIA (non-serious) with onset Oct2024, outcome "recovering", described as "Weak"; VACCINATION SITE DISCOMFORT (non-serious) with onset Oct2024, outcome "unknown", described as "it feels like it is on the left arm where I got the shot, it feels like I have like a nylon sleeve on my arm like all of the sudden there is something on my arm"; ABDOMINAL DISCOMFORT (non-serious) with onset Oct2024, outcome "unknown", described as "my stomach is really upset; Stomach was sick"; ARTHRITIS (non-serious) with onset 19Oct2024, outcome "unknown", described as "Arthritis has been it almost like it flared up more". Therapeutic measures were taken as a result of dyspepsia.  Additional information: No investigations done. The first week she had it like the first couple of days after it but what was really concerning her now was like, she felt very like, almost like dragged out and weaker and not only that, but it also seemed like her arthritis had been flared up more. Patient received the COVID shot or vaccine (clarified as Pfizer COVID-19 Vaccine) from Pfizer on 01Oct2024 (Tuesday, early afternoon). On 02Oct2024 (Wednesday) early morning patient had vomiting then she had digestion really not good for like almost like burning and her stomach was really upset and then by Friday (04Oct2024) she had vomiting again, Friday (04Oct2024) morning, in the morning 4 o'clock, the first was 5 o'clock in the morning on Wednesday (02Oct2024). Her stomach was sick for like days, after that but she had the vomiting twice. Then after that she had like, she was very tired, very dragged out and tired which she was not usually like that to that extent, unusually tired okay and draggy and weak, so felt kind of weak. She had received these shots in the past, she could remember having, when they had the first Booster (clarified as Pfizer COVID-19 Vaccine), she did have a reaction to that like almost like flu-like symptoms to that but then it went away after hours but this one, it was chaos and the next day on Wednesday (02Oct2024). She did feel like she had chaos and weakness, like body aches but the things that was mostly bothering her now because that kind of subsided. Now we are looking at the 19Oct2024 and she had been noticing that her arthritis (she had arthritis), it almost like it flared up more. It was like, she did not notice that and like again still with the kind of dragged out like by the afternoon she was like she felt like she was dragged out and she was not usually like that. She was older but usually she had pretty good energy and then there was another thing that she was getting and she noticed this when she first got the vaccines too and she thought it was weird, but she did not know what it was but now it happened again after getting the COVID Vaccine again especially like fall asleep during and in the afternoon more than she usually did. She was waking up and all of a sudden, it felt like it was on the left arm where she got the shot, it felt like she had like a nylon sleeve on her arm like all of the sudden there was something on her arm, like a sleeve and she was like what was that feeling and she was like she had never felt that before and that coincided with the shot, even prior to this like when she first got the shots but she just did not really associate it and she had not had it for a long time and then all of a sudden she took up the shot and now it was happening again. So, yes, she was thinking that had to be that then because she did not have it before. Then it went away and now it was back again. She had had it a couple of times." Patient wanted to know also, was this something she should be concerned about because like now she noticed too like, when of course when you lie down at night, it was getting worse with the back pain and at all that, this time she would have some mornings that were like worse than she had ever felt before. So, she was very concerned that did it do anything permanent to make her arthritis worse, was this something that she can contract, and asked what was going on. She was debating whether to get the shot again this time too because she had been essential worker and she really, she did go get tested when COVID first came out to see if she had it and maybe by the time, she went to get tested maybe it was gone but she had not had a sinus infection. She never got really sick during COVID or anything and she didn't know that even she had contracted it because she never went really sick, but she took it as, she figured, maybe she should get it but now she was thinking she had better never get it because like she said she went through COVID she never really got sick. She had, she was a cashier really like an essential worker and she had to stay at the register, and this was before the shots were even out, and all she had on was a cloth mask. She did pretty well without even getting so, she got it. Patient further stated about the Guillain-Barre syndrome, so was that the possibility that was part of that. Other medical condition or taking any other medications, Patient stated, "she had none of that. The only thing she had was, she did have arthritis and osteoporosis, but she had nothing else. She had no other. She did not have diabetes, hypertension and did not have any of that and that was what getting her. She did not have any underlying things/medical things, and she was the one that got the reaction to it. She did not understand but that's how it went. Regarding treatment, patient stated, she might have after a while took some Pepto-Bismol after she was not getting it. She was getting bad heart burn too, very bad heartburn. She better mentioned that she had a bad heartburn for days, few days. She took maybe the Pepto-Bismol trying to counteract it. A couple of days ago, a few days ago (Oct2024) she felt like she had fallen asleep in the chair because she was like, it made her tired of than usual in the afternoon and then when she woke up, it felt like there was a nylon sleeve on her forearm, on the left side where she got the shot. She said wait, she had got this before and she never got it prior to the COVID shot but after getting the shot she noticed that, but she was not really associating it with that and then when it happened again like the las time, she got a shot was probably a year ago or the last fall (2023) when she got the other COVID shot and then this year, she was trying to think if she even got that sensation then, she was not sure but this time she really got reaction to it compared to it before for some reason, she did not know why. It will come and go but it had, it happened here and there very random, but it was happening. The patinet did not know if Pfizer can help her to like, to cut down on the effects of this, if it was and that causing it because she couldn't, it coincided with the shot and like she said prior to that, the week before (Oct2024) she got the Flu shot and she had no reaction at all to that. That was a week before and she was getting them every year and she never got a reaction to the Flu shot ever. She never got Pneumonia, never got bronchitis.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400281996 same patient, different vaccine dose/different event;US-PFIZER INC-202400281997 same patient, different vaccine dose/different event;US-PFIZER INC-202400281998 same patient, different vaccine dose/different event;