Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Swollen tongue, Throat tightness, Tinnitus
Clinical narrative: Blood pressure went up to 160; patchy swelling; horrific post nasal drip; sore throat, which was purely a white drip, no green or yellow, white thickness going down throat; fatigue, and was very pale; fatigue, and was very pale; skin got itchy; Bell's palsy; nausea; phlegm in throat; muscle tightness in clavicle and upper back and neck; Lips started almost like swelling; shortness of breath; urinating frequently; felt soreness and fullness in urinary tract; after eating caller's tongue would feel swollen; Diagnosed caller with IBS, irritable bowel syndrome; muscle pain in wrists, feet, legs/achy muscles; bone snaps, feet hurt when walking; ear muffling, couldn't hear well, affected both ears; felt a popping sensation and tinnitus, still has tinnitus in left ear; heart was racing, all the time had palpitations; facial swelling; bleeding in both nostrils; neuropathy in both feet and lower legs, tingled like pins and needles; felt like something was blocking throat; couldn't swallow right; Thyroid felt enlarged; headache; inflammation like pins and needles going up head to brain/ inflammation of lips and not just in corners; Had horrible brain fog; had a swart, clarified like a line, of blisters in left top of scalp on hairline; had itching left side hairline 3 days later; shingles; neuropathy in both feet and lower legs, tingled like pins and needles; Affected stomach; bowels changed, very quickly; bowel movements turned yellow and soft, very weird, odd odor; bowel movements turned yellow and soft, very weird, odd odor; bowel movements turned yellow and soft, very weird, odd odor; tiny blisters on upper lip; angular cheilitis; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on (13Jul2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ER8730) at the age of 58 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 31Mar2021, outcome "unknown", described as "Affected stomach"; ABNORMAL FAECES (non-serious), FAECES SOFT (non-serious), FAECES DISCOLOURED (non-serious) all with onset 31Mar2021, outcome "unknown" and all described as "bowel movements turned yellow and soft, very weird, odd odor"; FREQUENT BOWEL MOVEMENTS (non-serious) with onset 31Mar2021, outcome "unknown", described as "bowels changed, very quickly"; SWELLING FACE (non-serious) with onset 02Apr2021, outcome "unknown", described as "facial swelling"; PALPITATIONS (non-serious) with onset 02Apr2021, outcome "unknown", described as "heart was racing, all the time had palpitations"; HYPOACUSIS (non-serious) with onset 03Apr2021, outcome "unknown", described as "ear muffling, couldn't hear well, affected both ears"; TINNITUS (non-serious) with onset 03Apr2021, outcome "not recovered", described as "felt a popping sensation and tinnitus, still has tinnitus in left ear"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "unknown", described as "Had horrible brain fog"; GOITRE (non-serious) with onset Apr2021, outcome "unknown", described as "Thyroid felt enlarged"; EPISTAXIS (non-serious) with onset Apr2021, outcome "unknown", described as "bleeding in both nostrils"; DYSPHAGIA (non-serious) with onset Apr2021, outcome "unknown", described as "couldn't swallow right"; THROAT TIGHTNESS (non-serious) with onset Apr2021, outcome "unknown", described as "felt like something was blocking throat"; BLISTER (non-serious) with onset Apr2021, outcome "unknown", described as "had a swart, clarified like a line, of blisters in left top of scalp on hairline"; PRURITUS (non-serious) with onset Apr2021, outcome "unknown", described as "had itching left side hairline 3 days later"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown"; INFLAMMATION (non-serious) with onset Apr2021, outcome "unknown", described as "inflammation like pins and needles going up head to brain/ inflammation of lips and not just in corners"; NEUROPATHY PERIPHERAL (medically significant) with onset Apr2021, outcome "recovered", PARAESTHESIA (non-serious) with onset Apr2021, outcome "unknown" and all described as "neuropathy in both feet and lower legs, tingled like pins and needles"; HERPES ZOSTER (non-serious) with onset Apr2021, outcome "unknown", described as "shingles"; ANGULAR CHEILITIS (non-serious) with onset 2021, outcome "unknown"; LIP BLISTER (non-serious) with onset 2021, outcome "unknown", described as "tiny blisters on upper lip"; BONE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "bone snaps, feet hurt when walking"; MYALGIA (non-serious) with onset Aug2021, outcome "unknown", described as "muscle pain in wrists, feet, legs/achy muscles"; IRRITABLE BOWEL SYNDROME (non-serious) with onset Nov2021, outcome "unknown", described as "Diagnosed caller with IBS, irritable bowel syndrome"; LIP SWELLING (non-serious) with onset Apr2022, outcome "unknown", described as "Lips started almost like swelling"; SWOLLEN TONGUE (non-serious) with onset Apr2022, outcome "unknown", described as "after eating caller's tongue would feel swollen"; URINARY TRACT PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "felt soreness and fullness in urinary tract"; MUSCLE TIGHTNESS (non-serious) with onset Apr2022, outcome "unknown", described as "muscle tightness in clavicle and upper back and neck"; NAUSEA (non-serious) with onset Apr2022, outcome "unknown"; PRODUCTIVE COUGH (non-serious) with onset Apr2022, outcome "unknown", described as "phlegm in throat"; DYSPNOEA (non-serious) with onset Apr2022, outcome "unknown", described as "shortness of breath"; POLLAKIURIA (non-serious) with onset Apr2022, outcome "unknown", described as "urinating frequently"; BELL'S PALSY (medically significant) with onset 05Jul2022, outcome "not recovered"; BLOOD PRESSURE INCREASED (medically significant), outcome "unknown", described as "Blood pressure went up to 160"; SWELLING (non-serious), outcome "unknown", described as "patchy swelling"; UPPER-AIRWAY COUGH SYNDROME (non-serious), outcome "unknown", described as "horrific post nasal drip"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat, which was purely a white drip, no green or yellow, white thickness going down throat"; FATIGUE (non-serious), PALLOR (non-serious), outcome "unknown" and all described as "fatigue, and was very pale"; PRURITUS (non-serious), outcome "unknown", described as "skin got itchy". The events "bell's palsy", "neuropathy in both feet and lower legs, tingled like pins and needles", "blood pressure went up to 160", "facial swelling", "affected stomach", "bowels changed, very quickly", "bowel movements turned yellow and soft, very weird, odd odor", "diagnosed caller with ibs, irritable bowel syndrome", "patchy swelling", "horrific post nasal drip", "sore throat, which was purely a white drip, no green or yellow, white thickness going down throat", "heart was racing, all the time had palpitations", "ear muffling, couldn't hear well, affected both ears", "felt a popping sensation and tinnitus, still has tinnitus in left ear", "bleeding in both nostrils", "felt like something was blocking throat", "couldn't swallow right", "thyroid felt enlarged", "had itching left side hairline 3 days later", "shingles", "tiny blisters on upper lip", "angular cheilitis", "muscle pain in wrists, feet, legs/achy muscles", "bone snaps, feet hurt when walking", "fatigue, and was very pale", "phlegm in throat", "muscle tightness in clavicle and upper back and neck", "lips started almost like swelling", "shortness of breath", "urinating frequently", "felt soreness and fullness in urinary tract", "after eating caller's tongue would feel swollen", "skin got itchy" and "nausea" required physician office visit. The events "headache", "inflammation like pins and needles going up head to brain/ inflammation of lips and not just in corners", "had horrible brain fog" and "had a swart, clarified like a line, of blisters in left top of scalp on hairline" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Acoustic stimulation tests: decreased, notes: Had hearing testing in left ear, hearing had decreased, gone down slightly; Biopsy: patchy swelling, no cancer or pre cancer seen; Blood pressure measurement: 160, notes: went up to 160; Endoscopy: Unknown Result; SARS-CoV-2 test: Negative; Streptococcus test: Negative; Ultrasound scan: Has a few polyps, nothing had changed there. Therapeutic measures were taken as a result of bell's palsy, neuropathy peripheral, blood pressure increased, swelling face, abdominal discomfort, frequent bowel movements, abnormal faeces, faeces soft, faeces discoloured, irritable bowel syndrome, swelling, upper-airway cough syndrome, oropharyngeal pain, palpitations, hypoacusis, tinnitus, epistaxis, paraesthesia, throat tightness, dysphagia, goitre, headache, inflammation, feeling abnormal, blister, pruritus, herpes zoster, lip blister, angular cheilitis, myalgia, bone pain, fatigue, pallor, productive cough, muscle tightness, lip swelling, dyspnoea, pollakiuria, urinary tract pain, swollen tongue, pruritus, nausea. Clinical course details: The patient went to doctors because patient had a severe adverse reaction almost immediately after getting the 1st dose of the vaccine, doesn't know if the reaction was an allergic reaction and this all occurred after 1st dose. Doctors called reaction a severe adverse reaction, not anaphylactic, but patient had reactions which patient body could not handle the vaccine, including facial swelling. Recently diagnosed with Bell's palsy last Tuesday. Patient age when adverse events started was 58 years old when patient got the 1st dose and then turned 59 years old 6 weeks later. First reaction was immediate, occurred about 5 hours after getting the 1st dose. Affected stomach, bowels changed, very quickly, bowel movements turned yellow and soft, very weird, odd odor. Facial swelling at day 3, around 02Apr2021, left side of face felt swollen internally, not externally, which patient got her shot on the left side. Had horrific postnasal drip and sore throat, which was purely a white drip, no green or yellow, white thickness going down throat. Had a terrible sore throat, thought had strep, tested negative for strep and Covid. The event was on and off, but nowhere near as bad. The patient heart was racing, all the time had palpitations, which started with the facial swelling. Now this was major concern the patient was having, ear muffling, felt like patient couldn't hear well, affected both ears. This started around 03Apr2021. In only left ear patient felt a popping sensation and tinnitus, still has tinnitus in left ear. Blood pressure went up to 160, normally blood pressure was in 120s, couldn't get blood pressure down for weeks. Was just about to be put on blood pressure medications, but was able to lower blood pressure with constant meditation because patient didn't want to go on any medications. Had hearing testing in left ear, hearing had decreased, gone down slightly. Was put on a taper of methylprednisone and Flonase with Claritin. Then the 1st week, patient developed bleeding in both nostrils, not where blood was pouring out, but would have bleeding, would put q-tip in nostrils and q-tip would be full of blood. Used mupirocin, which is a topical ointment that goes in nose, thought bacterial infection, continued on with blood in both nostrils for weeks. 2 weeks later patient had neuropathy in both feet and lower legs, tingled like pins and needles. The neuropathy was not ongoing, for most part the neuropathy has stopped. Next symptom was a week later, felt like something was blocking throat, couldn't swallow right. Thyroid felt enlarged, sent for emergency ultrasound. Has a few polyps which patient has always had, nothing had changed there, doctors weren't sure what was causing the swelling and making it hard to swallow well. Next thing, probably week 2, mid Apr2021, patient ended up in emergency room in because had a terrible headache and felt as if on another planet, strange headache, inflammation like pins and needles going up head to brain. Had horrible brain fog, did extensive blood panel which looked good. Confirmed patient was not admitted to the hospital. Thought maybe an autoimmune disease, so patient was sent to rheumatologist, and came back with no autoimmune disease. Then 3 days after going to the emergency room patient had a swart, clarified like a line, of blisters in left top of scalp on hairline, had itching left side hairline 3 days later. Rheumatologist said may have been a mild case of shingles brought on by the vaccine, and put patient on antivirals. Then patient had tiny blisters on upper lip, which probably started about a month after. That went into angular cheilitis, which went on and off through Oct2021, and lasted about 8 months. In Aug2021, patient started feeling very run down, had a lot of muscle pain in wrists, feet, legs. Mid August the tinnitus got a lot worse. Immune system seemed way down, was getting bone snaps, feet hurt when walking, couldn't do any exercise. In Nov2021, started having a lot of acid, stomach pain, indigestion, heartburn. Would have severe constipation followed by mucusy bowels. Diagnosed patient with IBS, irritable bowel syndrome. Said this was a random episode, which was weird because patient never had this occur before. These stomach issues went on 5 months. Finally did an endoscopy, stomach was killing patient all the time. Took biopsies, and said patient had patchy swelling, no cancer or pre cancer seen in biopsies. Doctors do not know what caused this. Patient doesn't drink alcohol, doesn't take Advil, so wasn't Advil. Said could be bile or something, stomach bile. Last episode was late Mar2022. Now patient was back to being somewhat constipated, which was more severe, feels like patient has lost motility. Patient had stomach issues on and off since getting the vaccine, the stomach issues were waxing and waning. Stomach issues got really bad through Nov2021-Mar2022, during that time patient mainly had stomach problems, fatigue, and was very pale. Next group of symptoms was during Apr2022, got extremely achy muscles and significant fatigue for 2 weeks. Tested negative for Covid. Had phlegm in throat, like post nasal, and another bleeding in nose again like patient had before. Was clearing throat constantly. Wrists and feet ached again. Horrible muscle tightness in clavicle and upper back and neck. Stomach problems started again but could control the stomach problems with omeprazole, like Pepcid. Lips started almost like swelling, inflammation of lips and not just in corners, not just the angular cheilitis, but tiny blisters up on top of lips, tiny dots that felt like sandpaper when rubbed together, extremely sore. When patient pulled out bottom lip, looked like tiny dark patches like blood spots inside lower lip, very mottled tissue. Had slight shortness of breath during that time also. Had a continuous feeling of lump or swelling in throat like before. Then patient started urinating frequently, felt soreness and fullness in urinary tract, but no infection. Sometimes after eating, patient's tongue would feel swollen, when using certain toothpastes mouth would burn like terrible burning. Tongue turned a little bit white for a short time. Then skin started to itch a little bit, weird, skin got itchy. Had terrible nausea one night, would eat foods and would get nauseas. And during all of this time upper muscles in clavicle and upper back were so tight, not from stress, was just very much coming out of nowhere, muscles would tighten up like in fight or flight. Patient got another headache like the headache that initially landed patient in emergency room, again had pins and needles felt like inflammation going up to brain. This happened in May2022, like 3rd week of May. Confirmed patient did not go to the emergency room this time. Recently diagnosed with Bell's palsy last Tuesday and was so hard to talk with Bell's palsy, on the same left side. Bells palsy was ongoing, only been a week so can't really tell, most people don't see movement until 2-3 weeks, patient has slight movement but still in flaccid state. The patient only received 1 dose, told to not get 2nd dose. Patient was very healthy before this, no underlying conditions, didn't take an medications, was 58 years old, didn't have high blood pressure. The patient wanted to know what was going to happen now. Patient requests that Pfizer follow up with her and this was not good enough for patient, all of this has destroyed patient's life, needs answers. Needs information about how to go to doctors and about how to deal with what was happening with patient. Patient would absolutely want a follow up from Pfizer about all of this. Doesn't have the patience or time to go through hold times, wants a referral from Pfizer for a doctor who knows how to deal with patient's adverse events. Doctors don't know what was going on. Patient knows Pfizer has that information. Pfizer must have resources for people who are injured. Patient wants help in getting her life back, wants a referral for a doctor who knows how to deal with this stuff. Patient asked if there has been any research in regards to what patient was experiencing and the vaccine.