Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, Wrong technique in product usage process
Clinical narrative: extensive severe inflammation throughout her pelvis; vaccine has magnified the inflammation; odd administration of the vaccine/ so painful. Didn't feel it went straight into her arm and it really hurt.; arthritis; weirdness; sore throat; waves of pain would make her nauseous with her jaw; excruciating pain in left shoulder, left arm, left side of her neck and her head; 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 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 (Lot number: FD7218) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diverticulitis", start date: Jan2021 (ongoing), notes: inflammation in her pelvic area could be related to her history of diverticulitis, Verbatim: Diverticulitis; "Retinitis pigmentosa" (ongoing), notes: Verbatim: Retinitis pigmentosa. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201 or EIV6201, the handwriting is hard to read.), administration date: 08Apr2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "arm soreness"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0171), administration date: 11May2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "arm soreness".The following information was reported: PELVIC INFLAMMATORY DISEASE (hospitalization), outcome "unknown", described as "extensive severe inflammation throughout her pelvis"; INFLAMMATION (hospitalization), outcome "unknown", described as "vaccine has magnified the inflammation"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), outcome "unknown", described as "odd administration of the vaccine/ so painful. Didn't feel it went straight into her arm and it really hurt."; PAIN (non-serious) with onset Dec2021, outcome "recovering", described as "excruciating pain in left shoulder, left arm, left side of her neck and her head./ pain all the way down her arm, in her shoulder, in her neck into her head and the waves of pain would make her nauseous with her jaw"; ARTHRITIS (non-serious), outcome "unknown", described as "arthritis"; FEELING ABNORMAL (non-serious), outcome "recovering", described as "weirdness"; OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "recovering", described as "sore throat"; NAUSEA (non-serious) with onset Dec2021, outcome "recovering", described as "waves of pain would make her nauseous with her jaw". The patient was hospitalized for pelvic inflammatory disease, inflammation (start date: 22Dec2021, discharge date: 24Dec2021, hospitalization duration: 2 day(s)). The events "extensive severe inflammation throughout her pelvis", "excruciating pain in left shoulder, left arm, left side of her neck and her head./ pain all the way down her arm, in her shoulder, in her neck into her head and the waves of pain would make her nauseous with her jaw" and "sore throat" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: inflammation; magnetic resonance imaging: increase, notes: increase in pelvic inflammation/tiny, tiny arthritis in the left part of her neck; pain assessment: 8 to 10; white blood cell count: normal. Therapeutic measures were taken as a result of pelvic inflammatory disease, pain, feeling abnormal. Clinical course: Patient did have an MRI done and it showed a "tiny bit" of arthritis on the left side of the neck, but it was noted that it should not cause "this level of pain." The NP correlated if she already have a little bit of inflammation in an area, through their experience, the vaccine has magnified the inflammation 10 times over. Due to the "tiny bit of arthritis" noted in the left side of her neck, the NP advised that getting the vaccine high on the left arm with the odd administration of the vaccine, it could have taken the tiny inflammation and magnified it in her case. Patient notes her "weird aching and discomfort" being "nominal" and last night it was more so located in her jaw. She does also note that it seems to be slowly resolving and hoping that the "weirdness will completely go away in the not too distant future" and she "hopes she dont get these for forever." Patient was taking PT through the (Name Withheld) as well in hopes to help relieve her symptoms. When she was in the ER in Dec, she stated she had imaging done and it did show increase in pelvic inflammation, however she also noted that she was diagnosed with diverticulosis Jan of last year. She went to the ER for discomfort in her colon/pelvic area as well as the significant pain in her neck, shoulder, and head area. They evaluated all of her concerns and deemed that the inflammation in her pelvic area could be related to her history of diverticulitis and be more of coincidental finding after having the booster. Patient was most concerned about the inflammation in her pelvic area vs the neck "stuff" because she now has the recommendation from a surgeon to remove her sigmoid colon due to 2 hospitalizations in one year, one being a complicated hospital stay and the other not. She was looking into a 2nd opinion at this time and was interested in the relevance of the vaccine to the pelvic inflammation because that can certainly affect the bigger picture for her and the decisions she had to make regarding surgery. Patient stated she had contacted (Name Withheld) regarding this as well but notes that "it was a very odd injection." She stated it was "so painful. Didn't feel it went straight into her arm and it really hurt." She told the pharmacist who administered the product "her other 2 did not hurt that bad" because she "yelled out a little bit." She asked him if it would still work and did it go in right and he advised that it would still work although she felt that he noted something was "off" but again, advised that the vaccine would still be effective. The NP that the patient saw afterwards, at the (Name Withheld), advised her that due to this experience, she should in the future get further COVID vaccinations in the thigh and have it done at the provider's office. She stated he may have missed the muscle and went into "fluid or hit a nerve" and each of those "can be very problematic." Patient asked at what point does Pfizer start seeing a pattern of reported adverse events that people are having, specifically significant inflammation, before making it known to the public. The Patient noted that these findings should be important to Pfizer and the scientists who are studying and working with the product. Patient said that she had her Pfizer COVID vaccine booster on 08Dec2021, she had the 1st 2 shots in Apr2021 and May2021 without any real issues she just had arm soreness. For this third dose she went to a (Name withheld) location and it was a very strange shot. Her first 2 doses were little pricks but for this one the pharmacist was kind of higher on her left arm than normal and it went in at a funny angle but it was extremely painful to where she even said oh my gosh that hurt, her other two didn't hurt like that. He made some comment about missing something but she didn't think much about it other than asking him if it was still going to work to which the pharmacist said yes. She doesn't remember the exact timing but a day or 2 later she started to get excruciating pain in her neck. She had already gone to the chiropractor and gotten an adjustment because if she slept on her neck or her back funny she needed an adjustment, that pain was almost gone but it was still there a tiny bit prior to having her booster dose. She should have never told the pharmacist that it was okay to give the booster dose in her left arm. So she already had that tiny bit of pain that sent her to the chiropractor 10 days before but after the booster dose the pain went though the roof. She had pain all the way down her arm, in her shoulder, in her neck into her head and the waves of pain would make her nauseous with her jaw. She was taking Ibuprofen and Tylenol around the clock. Probably around 22Dec2022 she was still dealing with all of this pain in her neck and her shoulder and then she started to have pain in her colon. Baseline she has diverticulitis, she had an acute complication in Jan2021 and she had no problems with it until 22Dec2021 so she went to the hospital for 2 things the excruciating pain in her neck, shoulder and her jaw into her head and then what felt like the beginning of a diverticulitis flare. The hospital focused on the diverticulitis flare but they did do an MRI of her spine and said they saw no reason for the pain, she did have a tiny area of arthritis in her neck but that wouldn't cause the level of pain that she was experiencing. She was then hospitalized on 22Dec2021 because her pelvis was fully inflamed, they didn't see any abscess or perforation, her white blood cell count was normal but they were concerned with the level of inflammation in her pelvis. She then spent the next 2 nights in the hospital. After 1 day of IV antibiotics, or whatever they had going in, her abdomen got better but she kept asking for pain medications because of her neck and shoulder hurting so bad. After the antibiotics she was released and sent home but then she ended up back in the emergency room 2 days later because she woke up and the pain was so bad in her neck, shoulder and arm that even the oxycodone that she was prescribed for the diverticulitis wasn't cutting it. She went back to the emergency room thinking that she was dying and that was actually when they did the MRI of her spine. They did it this 2nd time, not on the first emergency room visit that she had mentioned previously. Due to all of this she has been researching the heck out of this. One doctor said that she now needed to get her sigmoid colon removed because she 2 flares within a year but she was trying to get a 2nd opinion. She also went to the (Name Withheld) because she was referred there for physical therapy and to see an orthopedist because they couldn't figure out why she was having all this pain going on. (Name Withheld) also did an MRI of her spine, neck and shoulder and said that they couldn't find anything. She was telling the orthopedic nurse practitioner there that this all started a day or 2 days after she had her COVID vaccine booster and the nurse practitioner said that she thought that's the cause of the pain. The nurse practitioner has seen a number of cases like this and maybe the Patient the issue was either that maybe the pharmacist didn't give the vaccine in the muscle or with the Patient having that tiny inflammation, the tiny arthritis and already having to see the chiropractor sometimes, then maybe that affected it. She was just there getting physical therapy from them but she needed to if this was documented within Pfizer's resources. She did see that the vagal nerve runs from the neck down into part of the colon. All of this that she has been experienced has happened on her left side and she just needs to know about this from Pfizer. She did report this to the pharmacy and she was waiting to hear back from Walgreens on if they have anything to say regarding this. She wanted to know if there was any chance that the COVID vaccine caused something with her nerves on that side and then continued to aggravate her pelvis causing the inflammation because she needed to know. There was a surgeon who wanted to remove her colon because she has had a 2nd hospitalization within the last year that he was attributing to her diverticulitis. She had no issues with her first 2 doses and she doesn't know why the booster was like this for her, maybe it was how it was administered but she still believed that. Last night she was still getting weird sensations in her neck, jaw and her swallowing was a little weird. She also has been getting a slight sore throat. She has been tested for COVID and she doesn't have that. She just wanted Pfizer to know that, she is not at a level that would send her to the emergency room so she thought that it was getting better but the weird symptoms in her jaw, neck and throat are not 100% gone. She will go to the cupboard and get some Tylenol, she doesn't take Ibuprofen anymore, and the Tylenol helped her. If all of this had gone away she wouldn't have called about it but with it going on this long it was wigging her out about the discomfort. Not at this time, maybe some time down the road she will. When she has mentioned to probably 2 doctors that she thought the COVID vaccine may be part of all of her issues they look at her like she has horns and they just say that there is no empirical evidence for that but she knows that this was all new stuff. She has seen an orthopedic doctor, a surgeon, her family doctor and she has talked to a gastroenterologist on an online consult through the (clinic name). She has circled her bases in talking to medical professionals. Event Details: Inquired for when the pain began and she clarified and confirmed what was previously stated by saying that she was thinking that it began within 24 hours. She knew that she felt good at first because she has a son who became a marine and he was coming home so she was excited because her neck issue was pretty much gone and she wanted to get the booster to ensure that she didn't get sick and she didn't wanted to get him sick and him not be able to go back. So she remembered that because she felt so much better and then 24 hours later or so the pain just went through the roof, it was not just in her neck anymore it was the whole area. It was pretty much right on the heels of being within 24 hours or so of that booster. She said it had improved a lot so that gave her hope that whatever was causing it, the booster or something else, was not permanent. The orthopedic nurse practitioner said that she didn't think that there would be permanent damage. She was told to get it in the thigh because the muscle there was bigger. So if she got the courage to get another booster then she will get it but she will definitely not get it in her arm again. The pain was at an 8 to 10 when she went to the emergency room and then what was weird was that it would come in different parts of her left side in waves. It was just a weird thing. Then she would have a wave of nausea and now it's just creeping up at a lower level, maybe a 2 or a 3, at most. She has been trying to relax. She has the weirdness in her jaw, a little bit in her ear, and her throat has felt funny and was kind of annoying her last night. It was weird and was just probably at like a 2 or a 2 1/2 last night and she took 2 Tylenol. She felt a little weirdness this morning in the same area and took 2 more Tylenol. It was not nearly as severe as it was. Inquired for when the issues with her throat area began and she said that was the weird part. She thought that she may have had a minor sore throat. Again, it could all be unrelated. She went to an urgent care before she ever went to the emergency room around 20Dec2021 because of the pain she was having all around her neck. She was trying to remember if the sore throat started initially, she thought it did. She remembered that the doctor at the urgent care looked at her throat and saw some redness there and she was prescribed with something that they ended up changing at the hospital because they didn't feel like it was the right antibiotic for it. To make the long answer shorter it does seem like all of that started at the same time. She was trying to now think if she had any sore throat before she had the COVID booster but she can't remember for sure. She thought the sore throat developed after the COVID booster but it was the first thing that started and then the pain went deeper and was moving in all areas and that started shortly afterwards. Diverticulitis Flare: On her hospital release report they have that she had extensive severe inflammation throughout her pelvis area, this was what the emergency room doctor and the surgeon that treated her last Jan2021 had said. She was first told about her diverticulitis in Jan2021 and she had an issue in her sigmoid area, she had a micro perforation and a small abbess that they had to drain. At that time, Jan2021, she had a fever, a high white blood cell count and pain that was much, much greater. Honestly, if she wouldn't have had the neck and shoulder pain she may have ignored the Discomfort in her pelvic area at this time because it felt so minor, But that was what they called it but she did not have the elevated white blood cells and it didn't seem to be like the infection she had in Jan2021, it was just inflammation that was visible on a CT scan that they did on her pelvis. She was admitted to the hospital on 22Dec2021 and stayed on 22Dec2021 and 23Dec2021 and then they let her go home late on 24Dec2021. She thought that they would have kept her longer but other than her neck and shoulder still bugging her, they did another CT scan for that, she had no more concerns for her colon so they let her go home with a bunch of antibiotics. Arm Soreness: She said that the only symptoms that she had seemed to be that she was tired for so many hours after the 1st COVID vaccines and then she had a little arm soreness afterwards but nothing else. She confirmed these were side effects were felt after her 1st and 2nd dose of the Pfizer COVID vaccine. She got those doses in her right arm and for some reason the pharmacist suggested that she have the booster dose in her left arm, which is a different arm. Therapy start date populated as the date for the Patient's first COVID vaccine and the therapy stop date populated as the date for the Patient's booster COVID vaccine. 1st dose- 08Apr2021 Lot Number: She thought the lot number is either EN6201 or EIV6201, the handwriting was hard to read. 2nd dose- 11May2021 Lot Number: EW0171 booster dose- 08Dec2021 Lot Number: FD7218. History/ Investigations: So like she said the 2nd time that she went back to the emergency room, after they released her, because her neck, shoulder, arm and head pain was horrible they did an MRI of her spine and neck she guesses they were looking to see if there was any cancer and there said that they did not see any concerns other than the tiny, tiny arthritis in the left part of her neck that should never cause this level of pain. So she had no issues in her spine and neck. And like she said, the diverticulitis was a new diagnosis. She also has an eye condition that doesn't cause pain but it has caused her to lose her peripheral vision, this has been going on her whole life, she had good central vision but the diagnosis is retinitis pigmentosa. So that was another diagnosis but there was no treatment for it at this point in time other than to take care of herself. She doesn't think that there was anything else that was relevant. She will be going to (Name Withheld) for more neck exercises next Monday and for another therapy session. She might do dry needling in her neck area, they thought that might could help. Oxycodone: She said she only took a couple. She was dispensed 10 and there are 7 left, so she only ended up taking 3 when she got home from the hospital. She was hoping that it would help her neck and stuff but it didn't and after she took the 3rd she went to the emergency room. She realized Tylenol worked better for this and then she never took anymore of the Oxycodone. Inquired for NDC, lot number and expiry date and Patient declined to provide since those are not on the orange pharmacy bottle from (Name Withheld) that she has. She says the medication specifically is Oxycodone HCl 5 mg tablets. They gave her another pain killer in the emergency room through her IV but she doesn't remember what that was.   Follow-up attempts are completed. No further information is expected.