Sex: M
Vaccine: COVID19, FLUX, TTOX, VARZOS
Symptoms: Blood thyroid stimulating hormone, Off label use, Product use issue
Clinical narrative: increase in the patient's TSH level; The patient also got the "shingles vaccine and a tetanus shot vaccine", around the same time as the 2nd Pfizer booster dose was given; The patient also got the "shingles vaccine and a tetanus shot vaccine", around the same time as the 2nd Pfizer booster dose was given; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID.  A 60-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; tetanus vaccine (TETANUS VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01; DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (Dose:02; DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (Dose:03; DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious), outcome "unknown", described as "increase in the patient's TSH level"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "The patient also got the "shingles vaccine and a tetanus shot vaccine", around the same time as the 2nd Pfizer booster dose was given". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Agent stated that the caller stated the patient had a thyroid issue and was over 60 years old. The caller provided the patient's phone number and declined providing any demographics except for his first name. When asked to provide a callback phone number the HCP said use that number. HCP was calling regarding the Pfizer-BioNTech COVID-19 Vaccine, Omicron Bivalent gray cap formula. The patient received the Pfizer-BioNTech COVID-19 Vaccine primary series (Both doses) and also 2 monovalent booster doses. No issues or problems with the first 3 Pfizer Covid vaccines. There was an increase in the patient's TSH level following the patient's last (2nd) Pfizer-BioNTech COVID-19 Vaccine booster dose. The thyroid levels came down after 4 months per HCP. TSH was normal at the time of reporting and the HCP said he should get the Pfizer Bivalent booster shot. The HCP said the benefits outweigh the risks to the patient. The patient had deferred receiving the booster dose due to "anti vaxer propaganda" on the media, TV and the internet per the caller. Afraid to get the booster due to people saying "you're going to die from getting the boosters and everyone is going to die". The patient was concerned about developing "long term thyroid issues after receiving this new booster". The patient also got the "shingles vaccine and a tetanus shot vaccine", around the same time as the 2nd Pfizer booster dose was given. The patient had also received the new flu vaccine last week. The patient was asking about the incidence of myocarditis in patients over 60 when receiving the vaccine regarding Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent, Dose- Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), [greater than or equal to] 12 years -15/15 mcg per dos.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.