Sex: M
Vaccine: COVID19
Symptoms: Serotonin syndrome
Clinical narrative: This Jul unrelated to the COVID injection he got mild to moderate Serotonin in syndrome which was caused by his use of Tramadol; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID. The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 30Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tramadol (TRAMADOL), (Batch/Lot number: unknown) and steroid injections [received over a period of 5-6 months (29Nov to 01Mar)]. The patient's relevant medical history included: "Tremors" (unspecified if ongoing), notes: in one instance his doctor prescribed him Losartan and it doubled his tremors; "he is already disabled for four years" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Losartan, reaction(s): "It doubled his tremors", notes: in one instance his doctor prescribed him Losartan and it doubled his tremors. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: SEROTONIN SYNDROME (medically significant) with onset Jul2022, outcome "unknown", described as "This Jul unrelated to the COVID injection he got mild to moderate Serotonin in syndrome which was caused by his use of Tramadol". The action taken for tramadol was unknown. Therapeutic measures were taken as a result of serotonin syndrome.  Clinical course: Reporter shared that he was a travel nurse but is now disabled for 4 years (last worked on 2019) because of the steroid injections he had to take. He took 3 COVID Pfizer injections when they first came out and had his last one earlier this year. He then stated that this Jul unrelated to the COVID injection he got mild to moderate serotonin syndrome which was caused by his use of Tramadol. Got those symptoms in Jul. He also mentions that he had 4 steroid injections over a period of 5-6 months (29Nov to 01Mar). He wanted to know if the Pfizer COVID-19 vaccine has serotonin in it or if it has the possibility to cause an increase in his serotonin. He explains that he was asking this because in one instance his doctor prescribed him Losartan and it doubled his tremors. He also mentioned that he thought he saw some research regarding the Pfizer vaccine and serotonin so he wanted to make sure. Starting in Jul was tramadol and possibly related to 4 steroid injections from the 29Nov2021. Patient corrected that he just looked it up his last COVID injection was 30Aug2021. Patient was already disabled for four years and he developed mild to moderate serotonin syndrome and on the medication Tramadol (Antidepressant). He would like to know if the vaccine increases serotonin levels. He also mentioned that he did have any side effects from the medication.  The reporter considered "this jul unrelated to the covid injection he got mild to moderate serotonin in syndrome which was caused by his use of tramadol" not related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information, a casual association between the suspect product BNT162B2 and the reported event serotonin syndrome  was assessed as unrelated.