Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Ear pain, Immune system disorder
Clinical narrative: affected her immunity; Hashimoto thyroiditis; test showed higher level of TSH; feeling pain on left side a lymphatic thyroid pain and ear pain.; feeling pain on left side a lymphatic thyroid pain and ear pain.; This is a spontaneous report from a contactable pharmacist (patient). A 40-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL8982, expiration date unknown) via an unspecified route of administration at arm right on 04Feb2021 at 10:00 AM at age of 40-year-old at single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included in vitro fertilization (IVF). Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL0142, expiration date unknown) via unspecified route of administration at right arm on 13Jan2021 at 10:00 AM at age of 40-year-old for COVID-19 immunization. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included desogestrel, ethinylestradiol (ENSKYCE) within 2 weeks of vaccination. Patient reported that she never had thyroiditis in her life before. On 20Feb2021 at 06:00 AM (about two weeks after 2nd dose), patient started feeling pain on left side a lymphatic thyroid pain and ear pain. Doctor prescribed antibiotics. She was in the middle of IVF process and had all record no thyroid issues before this date. Blood test on 29Apr2021 showed higher level of TSH, on 08May2021 showed higher level and on 14May2021 showed that level become 6.05. Patient made appointment with endocrinologist. And today on 19May2021, she was diagnosed with acute Hashimoto thyroiditis. She had all her thyroid records never had any issues. Patient stated that she was not too sure if this was caused by vaccine but certainly affected her immunity. Patient was prescribed levothyroxine to start from tomorrow (20May2021). Her IVF was cancelled till her TSH level get fixed. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received Ultrasound of thyroid, antibiotics, levothyroxine as treatment for the events. Outcome of event "affected her immunity" was unknown, of the other events was not recovered. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Patient had COVID test post vaccination included nasal swab on 30Mar2021 which was negative.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on autoimmune etiology of reported  autoimmune thyroiditis and event  occurrence post two doses of vaccination and  elevated TSH levels, the causal role of BNT162B2 vaccine cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate