Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood creatinine, Electrocardiogram, Glomerular filtration rate, Lip swelling
Clinical narrative: upper lip is swollen and stiff; upper lip is swollen and stiff; burning in mouth with toothpaste; 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 77-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Oct2021 15:25 (Lot number: EW0202) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Verbatim: High cholesterol" (unspecified if ongoing); "rapid heart rate" (unspecified if ongoing); "Verbatim: moderate kidney disease" (unspecified if ongoing); "Verbatim: Osteoporosis" (unspecified if ongoing); "If the caller eats furry fruits or nuts she gets a little sore in her mouth and bladder frequency" (unspecified if ongoing); "If the caller eats furry fruits or nuts she gets a little sore in her mouth and bladder frequency" (unspecified if ongoing); "sore in her mouth" (unspecified if ongoing), notes: eats furry fruits or nuts she gets a little sore in her mouth and bladder frequency; "bladder frequency" (unspecified if ongoing), notes: eats furry fruits or nuts she gets a little sore in her mouth and bladder frequency. Concomitant medication(s) included: FLUZONE HIGH DOSE QUADRIVALENT, administration date 24Sep2021. Vaccination history included: Bnt162b2 (First Dose: lot EL3249, NDC, and expiration date unknown.), administration date: 11Feb2021, when the patient was 76 years old, for Covid-19 immunization; Bnt162b2 (Second Dose: lot EM9810, NDC, and expiration date.), administration date: 04Mar2021, when the patient was 76 years old, for Covid-19 immunization, reaction(s): "sore arm", "sensitive mouth", "rapid heat rate", "tired", "burning in mouth with toothpaste".  The following information was reported: LIP SWELLING (non-serious) with onset 2021, outcome "not recovered", MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown" and all described as "upper lip is swollen and stiff"; ORAL DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "burning in mouth with toothpaste". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information The patient with medical history of rapid heart rate who received the first dose of the Pfizer Covid-19 vaccine on 11Feb2021, the second dose of 04Mar2021, and a third/booster dose on 20Oct2021. Prior Vaccinations (within 4 weeks): Vaccine Flu zone HD 65 plus Manufacturer: Unknown Lot Number: PF2021-22 Route, Anatomical Location: unknown Date: 24Sep2021 RX 812594, Store 15004 INJ 0.7 ml. AE(s) following prior vaccinations: soreness at the site of the injection. Family Medical History Relevant to AE(s): When the patient mom got a bee sting, she would swell up from it. The patient has high both good and bad cholesterol. After the second dose of the Pfizer Covid-19 vaccine, the patient had complaints of mouth sensitivity, burning in the mouth from toothpaste that lasted two weeks (per agent), and feeling tired. Patient states that she used 2-3 different toothpastes and after several weeks used one that was less reactive, and the above complaints lessened. Patient reports that after receiving the third dose of the Pfizer Covid-19 vaccine that she is having complaints of burning in her mouth from toothpaste, mouth sensitivity, and her upper lip is swollen and stiff. The patient reports that she usually has soreness with other vaccines. Patient is asking if taking antihistamines would help with her above complaints after receiving the booster dose of the Pfizer Covid-19 Event as reported by primary source: second dose: sensitive mouth  From: 05Mar2021 To: 17Mar2021 Duration of reaction/event: 12 Day Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED WITH SEQUEL, rapid heat rate From: 06Mar2021 To: 20Mar2021 Duration of reaction/event: 14 Day Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED ,tired  05Mar2021 To: 05Mar2021 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED. Reaction/event as reported by primary source: Third dose: burning in mouth with toothpaste from: 21Oct2021 to: Ongoing and swollen lip from: 22Oct2021 to: Ongoing, swollen lip was reported as worsened.  Additional Context. The patient had the third dose the day before yesterday. After the second dose and yesterday the patient got very sensitive to the toothpaste, it would burn her mouth. After the second dose it lasted for a couple of weeks. Yesterday when the patient tried to use her least sensitive toothpaste her mouth burned, and her upper lip is swollen this morning. The burning in the patient mouth with toothpaste did go away a couple of weeks after the second dose. The patient is afraid to use toothpaste. The patient is asking can antihistamine help reduce the swelling of the lip. After the second dose the patient was very tired the next day and had a rapid heart rate with very light activity, it got up to 134 beats per minute. So far that hasn't happened with the third dose, the patient heart rate has gotten up to 120 and is lurking around 92 when she isn't really working out. This is higher than usual, the patient usually is around 69-72 so this is a little bit of a rapid heart rate. Because the patient had the rapid heartbeat after light activity for a few weeks after the second dose. The patient saw her doctor Date: 15Oct2021 for an EKG before the booster and it looks normal and so her doctor told her to get the booster. The patient had burning in her mouth before and its not feeling swollen and does not. The patient stayed away from some of the toothpaste that caused the burning for a couple of weeks. The patient had a sore arm after the second dose but was better because she did arm movements. The patient has very little soreness in her shoulder now. The patient didn't feel it when she got the third dose of the vaccine and said, "did you give it to me" the man giving it said she didn't feel it because he was talking to her. The patient walks 3 times a week and exercises 6 times a week. The patient moved in her weights that she lifts at the gym from 6.6 to 10 pounds. The patient rinsed her mouth after she brushed her teeth yesterday and thought that would take care of it. The patient guesses some if it got absorbed because her upper lip is swollen this morning. The patient mouth isn't raw, but her lip is worse. The patient hadn't had any water for 14 hours before she got her labs drawn so her creatinine and bilirubin were a tiny bit out of range. The patient GFR was 54. The any of adverse event did not require a visit to Emergency Room nor Physician Office.   No follow-up attempts are possible. No further information is expected.