Age: 67.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Tooth restoration
Clinical narrative: Swelling was from the inside of my lips out and my lips have got dried, cracked and chapped; I had a tooth filled; they used the Lidocaine so my mouth was numb when I went to get my injection; I had a tooth filled; they used the Lidocaine so my mouth was numb when I went to get my injection; They also used Lidocaine with Epinephrine and then plain Lidocaine. She gave me two shots; Dry mouth; Swelling was from the inside of my lips out and my lips have got dried, cracked and chapped; Swelling was from the inside of my lips out and my lips have got dried, cracked and chapped; Blisters on my lips, little tiny pin point blisters; Taste metallic; The first dose was 03-JAN-2021. The seond dose was 13-FEB-2021.; ended up with a severe rash, it went all the way around my arm as wide as my hand and itching, which was severe/adverse effects to other injection/I had such a bad reaction; This spontaneous report has been received from a retired nurse referring to herself, a 67 years old female patient. The patient's concurrent conditions included hypertension, chronic kidney disease stage 3, Hashimoto's disease and gastrooesophageal reflux disease (GERD). The patient's medical history included tumor on thyroid that had been removed when she was 22, she had no thyroid since then. Concomitant therapies included levothyroxine sodium(SYNTHROID), diltiazem hydrochloride, olmesartan medoxomil(BENICAR), esomeprazole magnesium(NEXIUM), colecalciferol(VITAMIN D3), eicosapentaenoic acid ethyl ester(VASCEPA), ranitidine hydrochloride(ESPAVEN) and cetirizine hydrochloride(ZYRTEC).  On 16-NOV-2020, the patient was vaccinated with a Pneumovax vaccine (unsure it was pneumococcal vaccine 13v or pneumococcal vaccine pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), both captured as suspect) (strength, dose, route, lot # and expiration date were not reported)for prophylaxis. After a day or so, the patient started swelling and just started itching all over her body and then the rash appeared. It lasted for a week and she took diphenhydramine (BENADRYL) every day. Then she finally went to doctor and was put on an antibiotic and prednisone for 10 days. She said it's such a bad reaction with this rejection.  On 03-JAN-2021, the patient received first dose of tozinameran(PFIZER BIONTECH COVID-19 VACCINE) (lot#: EL9261 in right arm). On 13-FEB-2021, she received the second dose of tozinameran(PFIZER BIONTECH COVID-19 VACCINE) (lot#: EN6201, in left arm) (inappropriate schedule of product administration). On 23-AUG-2021, she had a tooth refilled and lidocaine was used so her mouth was numb. She future noted that they also used epinephrine bitartrate (+) lidocaine and then plain lidocaine. She had two shots (extra dose administered). On the same day, she received the third dose of tozinameran(PFIZER BIONTECH COVID-19 VACCINE) (lot#: GWE167, in right arm). On the same day evening, after the third injection, she had lips swelling and a few days later she had dry mouth, blisters on lips, little tiny pin point blisters and the swelling was from the inside of her lips out and her lips have got dried, cracked and chapped. She also had metallic taste from about the third day of vaccination. She used vaseline and aquaphor on her lips and the chapstick because they were so dry. She noted her lips was still dry but was getting better. The dry mouth was cleared up. The metallic taste was now gone but she still had a little bit of swelling in her upper lip underneath but no sores or anything. The outcome of dry mouth, rash pruritic and metallic taste was reported as recovered. The outcome of chapped lips, hypoaesthesia oral, tooth repair, lip blister and lip dry was unknown. The reporter considered rash pruritic to be related to Pneumovax vaccine. The causality assessment for other events was not provided.