Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lip blister, Lip dry, Lip swelling, Paraesthesia oral
Clinical narrative: 3rd dose/booster dose; metallic taste; lip swelling/ Swelling was from the inside of my lips out; tingling; extreme dry mouth; Blisters on my lips, little tiny pin point blisters; my lips have got dried, cracked and chapped; my lips have got dried, cracked and chapped; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 23Aug2021 (Lot number: GWE167) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Stage 3 Kidney Disease" (unspecified if ongoing), notes: Stage 3 Kidney Disease about 10 years; "GERD" (unspecified if ongoing); "tumor on my Thyroid" (not ongoing), notes: I had a tumor on my Thyroid that had been removed when I was 22. Concomitant medication(s) included: SYNTHROID taken for autoimmune thyroiditis; VASCEPA taken for blood triglycerides abnormal; DILTIAZEM HYDROCHLORIDE taken for blood pressure abnormal, arrhythmia; BENICAR taken for blood pressure abnormal; VITAMIN D3; NEXIUM [ESOMEPRAZOLE SODIUM] taken for gastrooesophageal reflux disease; ESPAVEN; ZYRTEC. Vaccination history included: Bnt162b2 (Dose: 1, first dose was 03Jan2021 , LOT# of first dose: EL9261., The first one was around 9 o clock in the morning, Route of Administration: Consumer stated, "Where I , got it. It was muscular, Anatomical location: right arm), administration date: 03Jan2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, The second dose was 13Feb2021 (Clarified as 13 Feb2021).", LOT# second dose: EN6201., The second one was around 10, Route of Administration: Consumer stated, "Where I , got it. It was muscular, Anatomical location: left arm), administration date: 13Feb2021, when the patient was 67 years old, for COVID-19 immunization; Pneumovax 13 (Last year 16Nov; had a Pneumovax; ended up with a severe rash, it went all the way around my arm as wide as my hand and itching, which was severe), administration date: 16Nov2020, reaction(s): "severe rash", "itching"; Pneumovax 23. The following information was reported: IMMUNISATION (non-serious) with onset 23Aug2021, outcome "unknown", described as "3rd dose/booster dose"; DYSGEUSIA (non-serious) with onset 23Aug2021, outcome "recovered" (2021), described as "metallic taste"; LIP SWELLING (non-serious) with onset 23Aug2021, outcome "recovering", described as "lip swelling/ Swelling was from the inside of my lips out"; PARAESTHESIA ORAL (non-serious) with onset 23Aug2021, outcome "unknown", described as "tingling"; DRY MOUTH (non-serious) with onset 23Aug2021, outcome "unknown", described as "extreme dry mouth"; LIP BLISTER (non-serious) with onset 2021, outcome "unknown", described as "Blisters on my lips, little tiny pin point blisters"; LIP DRY (non-serious), CHAPPED LIPS (non-serious) all with onset 2021, outcome "recovering" and all described as "my lips have got dried, cracked and chapped". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysgeusia, lip swelling, paraesthesia oral, dry mouth, lip blister, lip dry, chapped lips.  Additional information: Reporter(retired Nurse) stated, "I can barely read it. It looks like, it might be a GWE167. Patient had a history of "allergic reactions to injections and vaccine". Further Consumer stated, "It just lasted a long, long time but I had adverse effects to other injection. Last year 16Nov, I had a Pneumovax and I ended up with a severe rash, it went all the way around my arm as wide as my hand and itching, which was severe (event captured as per verbatim). I did not have the itching with flu shots because we get the one with the older generations, I had some swelling and itching with it (further clarification unknown, hence not captured as event)." Name of Vaccine: Consumer stated, "I do not remember, I had done it at (place withheld) and he was going to check and see if he could get me one for this year because you could get them a year apart but Pneumovax 13 and then the 23. You get them a year apart and he was going to check and see if they could get one with the preservative free. Since, I had such a bad reaction. He thought maybe it was the preservative." Patient do not have that Lot number but it took a day or so and then I started swelling and just started itching all over my body and then the rash appeared and then it lasted for a week and I took Benadryl (treatment) every day. Then I finally went to my doctor and she put me on an Antibiotic and Prednisone for 10 days. So I seem to have first reactions with some injections but this is the first one she had with the Pfizer." Family Medical History relevant to event: Consumer stated, "No, not that I am aware of. Not all family members have received it no reaction". Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Patient had the third Pfizer, COVID vaccine and that day patient started getting like a little metallic taste, nothing bad and then patient's lips started swelling and patient got all these little, patient thought it was a fever blister but it was all these little pins like and patient never had one like that before. Patient 'checked' my bottom lip and patient didn't have any sores inside the mouth but the lips swelled, they were tingling, patient had very extreme dry mouth and patient still have it and that was done on the 23Aug2021 and patient still have it but it's gone down quite a bit. It was just uncomfortable. Patient was taking Prednisone (Treatment) to help with the swelling. Patient reported it almost felt numb at times and tingly and that morning before patient had the Pfizer shot, patient did have a tooth filled and patient had Lidocaine and Lidocaine would that be and then a couple of hours later, patient went and got the vaccine. Patient's mouth was still a little numb. So patient did notice the Lidocaine could make that onset worse or what but did notice patient, that had something to do with. Patient reported dry mouth, swelling of the lips, blisters on the lips, little tiny pin point blisters and the swelling was from the inside of the lips out and the lips have got dried, cracked and chapped since then but they were healing. Patient reported patient thought the metallic taste took a few days before patient started feeling that, tasting that but the lips swelling started that evening and the little blisters came out a few days later. Patient used Vaseline and Aquaphor on the lips and just the Chapstick because they were so dry. Still dry but they were getting better but it was been a long time. Long past since the 23Aug2021. Patient did start on Prednisone (4 mg each tablet, Lot: 2035145 and expiry date: Jun2022) (Treatment) on 12Sep2021 (reported as yesterday) and it helped immensely. Patient was just taking 20 mg once a day, that's it patient started on it yesterday and patient would take it once a day after patient have breakfast and patient would do that until all the swelling have completely gone and the lips are back to normal, probably 5 days more. Patient had nothing changed in the diet or the medicine or patient have not received any kind of any other inoculation. In fact, patient was waiting to get the flu shot that patient going to wait till these are gone before patient get it. Patient further reported that patient still had the metallic taste. The dry mouth was cleared up. The metallic taste was now gone but patient still had a little bit of swelling in the upper lip underneath but no sores or anything but underneath the lip it just cracked and dry. Reporter mentioned that she still had the "swelling", ever since 23Aug2021. Reporter also had "little tiny blisters on the lips that did not resemble like a cold sore, at all". Currently on prednisone ("instead of methasone") for the swelling but was currently going away. She stated that the her lips are "dry and cracky", but the metallic taste had gone away; "It's going down, just a little bit of chapped lips right now; no bleeding or any sores". Patient had the thyroid checked, the Vitamin D checked. They were normal. Patient had the kidneys checked. The GFR (glomerular filtration rate) was 54 (unspecified). That was good for the patient because patient had kidney disease from medications patient had taken previously years ago. And blood count was normal. Everything was good. Reported also stated the she was fine, and that her symptoms are going down and not big but annoying. Reporter would like to know if this had been a commonly reported adverse event post-vaccination.  Follow-up attempts are completed. No further information is expected.