Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Tongue disorder, Tongue ulceration, Tonsillar erythema, Tonsillar hypertrophy
Clinical narrative: mouth very sore; Sore glands on the left side of her neck, under her chin/sore glands; tonsils are swollen; Tonsils are red and swollen; Yellow tongue; Chest pain; sore throat; ulcers in the mouth and tongue; headaches/severe headaches; ulcers in the mouth and tongue; shortness of breath; Sore tongue, painful from the ulcers; can hardly open her mouth, painful to talk; cold sore treated like yeast infection; This is a spontaneous report from a contactable consumer (patient's grandmother) via medical information team. A 13-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: FA7485, patient was 13-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 21Jul2021 at 06:00 PM as DOSE 1, SINGLE DOSE for COVID-19 immunisation. Medical history included was exposed to COVID from 17Jul2021 to an unknown date. There were no concomitant medications. It was reported that a day before reporting in the grocery store, patient was found laying or sitting on the ground due to some shortness of breath, headaches didn't start until after the COVID-19 Vaccine. Patient has never complained of headaches and was crying for a while. It was reported that patient originally came to caller stating she had a sore on her tongue. Caller originally thought it was a cancker sore. Next day, patient stated the sore still hurt. By Saturday night, the sore had tripled in size to the size of a pea. It is not a white spot, but raw like a crater. This morning, patient woke up with two sores on the roof of her mouth with outcome as not as bright red, still the same, but not getting any bigger or better. It was confirmed that patient has not had a positive COVID test. Is trying to get patient a COVID test for free. Confirmed patient has not yet received her second dose. Caller is scared for patient to get second dose. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. On 22Jul2021, the patient experienced ulcers in the mouth and tongue, on 21Jul2021, the patient experienced headaches/severe headaches, on 24Jul2021 at 22:30, the patient experienced yellow tongue, on 24Jul2021, the patient experienced chest pain (pointing under her rib cage), sore throat, on an unspecified date in Jul2021, the patient experienced ulcers in the mouth and tongue, shortness of breath, on 26Jul2021, the patient experienced mouth very sore, sore glands on the left side of her neck, under her chin/sore glands, on 25Jul2021, the patient experienced tonsils are swollen, tonsils are red and swollen, sore tongue, painful from the ulcers, can hardly open her mouth, painful to talk. The patient underwent lab tests and procedures which included tonsil thing for strep throat resulted as negative on 25Jul2021 Stated tonsils were red and swollen. Patient received treatments for event (headaches/severe headaches) with Excedrin and for event (yellow tongue) with Nystatin: Swish/gargle/drink 100,000mg; Valtrex: 1 gram; Fluconazole: 150mg, one pill now and one pill in five days. AE(s) require to visit to physician Office. Reported that case was not serious. Reported that patient did not have any of these issues until after the first shot. The outcomes of events (ulcers in the mouth and tongue, tonsils are swollen, Tonsils are red and swollen, shortness of breath, can hardly open her mouth, painful to talk, cold sore treated like yeast infection) was unknown, the outcomes of events (ulcers in the mouth and tongue, headaches/severe headaches, Yellow tongue, Chest pain, sore throat, mouth very sore, Sore tongue, painful from the ulcers, Sore glands on the left side of her neck, under her chin/sore glands) was not recovered.   Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.