Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: SARS-CoV-2 test negative, Swelling, Urticaria
Clinical narrative: horrible stomach pain; itching; legs weak/physically weak from legs up to arms; she has been weak. Back area, like spine; shortness of breath; severe migraine headaches; low blood sugars; balance issues; autoimmune issues to begin/all came on at once after vaccine/autoimmune disease/this reaction came on after the vaccine; autoimmune issues to begin with/has been weak. Back area, like spine, felt weak, legs weak, physically weak from legs up to arms/had shortness of breath/but after the shot, this was all brought on; Guillain-Barre; mastoid up to inner ear was itchy, clarified she has mastoiditis and behind ear gets swollen; Hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 11Aug2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for immunisation; for immunisation. The patient's relevant medical history included: "SPINK1" (unspecified if ongoing), notes: A genetic condition that causes pancreatitis; amylase done which was high; "Pancreatitis" (unspecified if ongoing); "amylase done which was high", start date: 2023 (unspecified if ongoing); "autoimmune issues to begin with/autoimmune disease" (unspecified if ongoing), notes: since then has been weak; "Polyglandular at heart" (unspecified if ongoing); "Bones" (unspecified if ongoing), notes: On Forteo; "Pressure" (unspecified if ongoing), notes: on losartan; "Myasthenia gravis" (unspecified if ongoing); "gastrointestinal things/digestive issues" (unspecified if ongoing), notes: that came up on test; preexisting; "severe low blood sugars, said reactive hypoglycemia" (unspecified if ongoing); "something for gallbladder" (unspecified if ongoing). She also gets severe low blood sugars, said reactive hypoglycemia, really happens when she has autoimmune issues, she thought polyglandular at heart with what's going on with her condition. She has a condition called SPINK1, a genetic condition that causes pancreatitis, recently had blood tests done because wanted to make sure caller didn't have Covid, took Covid test (2023) which was negative, but did have amylase done (2023) which was high. Concomitant medication(s) included: MESTINON taken for myasthenia gravis, start date: 2021 (ongoing); LOSARTAN taken for blood pressure abnormal (ongoing); LEVOTHYROXINE (ongoing); FORTEO taken for bone disorder; NALTREXONE taken for autoimmune disorder, polyglandular disorder; Mestinon for myasthenia gravis which she uses a lot, can take up to 5 a day but caller takes 4 a day typically, has been taking for years; losartan but not really taking every day because pressure gets low, but is recommended to take every day; levothyroxine which caller has taken for a number of years; Forteo, an injection for bones; naltrexone, off label, given to caller for autoimmune disease; and taking as needed something for gallbladder, no product name provided and vitamins. Vaccination history included: Pneumococcal vaccine (Pneumonia vaccine about 2 years before), administration date: 2021, when the patient was 69 years old, for Immunization, reaction(s): "Autoimmune issues". The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 11Aug2023, outcome "not recovered", described as "horrible stomach pain"; GUILLAIN-BARRE SYNDROME (medically significant) with onset Aug2023, outcome "unknown", described as "Guillain-Barre"; URTICARIA (non-serious) with onset Aug2023, outcome "recovering", described as "Hives"; DISEASE RECURRENCE (medically significant) with onset Aug2023, outcome "unknown", described as "autoimmune issues to begin with/has been weak. Back area, like spine, felt weak, legs weak, physically weak from legs up to arms/had shortness of breath/but after the shot, this was all brought on"; AUTOIMMUNE DISORDER (medically significant) with onset Aug2023, outcome "unknown", described as "autoimmune issues to begin/all came on at once after vaccine/autoimmune disease/this reaction came on after the vaccine"; BALANCE DISORDER (non-serious) with onset Aug2023, outcome "unknown", described as "balance issues"; PRURITUS (non-serious) with onset Aug2023, outcome "recovering", described as "itching"; MUSCULAR WEAKNESS (non-serious) with onset Aug2023, outcome "unknown", described as "legs weak/physically weak from legs up to arms"; BLOOD GLUCOSE DECREASED (non-serious) with onset Aug2023, outcome "unknown", described as "low blood sugars"; MASTOIDITIS (medically significant) with onset Aug2023, outcome "unknown", described as "mastoid up to inner ear was itchy, clarified she has mastoiditis and behind ear gets swollen"; MIGRAINE (non-serious) with onset Aug2023, outcome "unknown", described as "severe migraine headaches"; ASTHENIA (non-serious) with onset Aug2023, outcome "unknown", described as "she has been weak. Back area, like spine"; DYSPNOEA (non-serious) with onset Aug2023, outcome "unknown", described as "shortness of breath". The event "horrible stomach pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood glucose: (Aug2023) Low; Computerised tomogram: (2023) Unknown result; Test: (2023) gastrointestinal things that came up on test, notes: stated were preexisting; SARS-CoV-2 test: (2023) Negative. Clinical course: Calling about Prevnar 20 vaccine, has some questions and also had a reaction to the vaccine. Right after the vaccine (Aug2023), she started to get hives; and the same day she got the vaccine she got horrible stomach pain (11Aug2023). Hives started right after, right away, not sure if hives started the same day that she got the vaccine but remembered thinking that she thought she had mosquito bite but then had bumps. She was really sick, remembered was connected to the vaccine. Hives was not really ongoing, but was very intense, had big bumps, but over time subsided and itching and bumps wouldn't be as bad. Horrible stomach pain started on the same day that got the vaccine. She ended up in the hospital, clarified and confirmed was not admitted to the hospital but was seen in emergency department. She had to test further, had gastrointestinal things that came up on test (2023) that she stated were preexisting. She was seen and given CAT scan (2023) and told to follow-up with doctor. (Stomach) pain was so severe. She has underlying digestive issues, stating she probably needed gallbladder out but this was pain that was beyond, couldn't tolerate walking around the pain was so severe. Horrible pains didn't subside. She did have continuing stomach pain, which was sort of magnified because she had gallbladder that was probably going to come out but was way magnified. She had a lot of the conditions that she had in the past, but all came on at once after vaccine. She had autoimmune issues to begin with, since then she has been weak. Back area, like spine, felt weak, legs weak, had shortness of breath, which she was getting with autoimmune disease; but after the shot, this was all brought on, she doesn't know if Guillain-Barre, but she has history of autoimmune disease. She was also very physically weak from legs up to arms, has had weakness before, had autoimmune disease, but this reaction came on after the vaccine. From mastoid up to inner ear was itchy, clarified she has mastoiditis and behind ear gets swollen. Also had severe migraine headaches for 4 or 5 days. She wasn't getting low blood sugars before taking Prevnar 20, but then this brought on low blood sugars. Started to get weak again, low blood sugars, weakness in spine, balance issues. She was a little frail at that time anyway due to issues with immune system. She was trying to find out how long Prevnar 20 stays in system because she believes connected to all of the symptoms she has now.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein) has been requested and will be submitted if and when received.