Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Pain, Tearfulness, Tinnitus
Clinical narrative: Relapse of bipolar depression; feeling depressed; became tearful; joint pain/ burning pains in her small joints; joint pain/ burning pains in her small joints; aches and pains; myalgia; Ringing in her ears; This case was reported in a literature article and described the occurrence of bipolar depression in a 49-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included bipolar depression and attention deficit hyperactivity disorder. Previously administered products included buspirone (15 mg twice/day), lurasidone (20 mg/day), oxcarbazepine (300 mg twice/day), trazodone (50 mg at bedtime) and lisdexamfetamine (30 mg in the morning).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, couple of hours after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced bipolar depression (serious criteria GSK medically significant), depressed mood, tearfulness, joint pain, burning sensation, pain, myalgia and ringing in ears. The patient was treated with celecoxib. On an unknown date, the outcome of the bipolar depression, depressed mood and tearfulness were recovered/resolved and the outcome of the joint pain, burning sensation, pain, myalgia and ringing in ears were unknown.   The reporter considered the bipolar depression, depressed mood, tearfulness, joint pain, burning sensation, pain, myalgia and ringing in ears to be possibly related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follow: This case was reported in a literature article and described the occurrence of relapse of bipolar depression in a 49-years-old female patient who was vaccinated with unspecified seasonal Influenza vaccine (manufacturer unknown) for prophylaxis. This white female patient had history of bipolar depression well controlled on her regimen of medications, which included buspirone 15 mg twice/day, lurasidone 20 mg/day, oxcarbazepine 300 mg twice/day, trazodone 50 mg at bedtime, and lisdexamfetamine 30 mg in the morning (for comorbid attention-deficit/hyperactivity disorder), and was seen for a routine follow-up visit. At that time, her depression was in full remission, and she had scored 0 on the 9-item Patient Health Questionnaire (PHQ-9). No information on patient's family history was provided. On an unspecified date, a week earlier to clinic visit, the patient received unspecified seasonal Influenza vaccine (administration route and site unspecified; dosage unknown; batch number not provided). The age at vaccination was not reported. On an unspecified date, within a couple of hours after vaccination, the patient started feeling depressed and became tearful. These symptoms were followed a couple of days later with aches and pains, which escalated over the subsequent days. The patient complained of joint pain, burning pains in her small joints, and myalgia. The patient rated her pain as 6/10. The patient also noticed ringing in her ears for the previous 2 days. Two weeks later from routine visit, the patient returned to the clinic for an urgent, unscheduled visit due to escalating depression, which was rated as 18/27 on the PHQ-9 (a score of 15-19 considered moderately severe). The patient received celecoxib 200 mg twice/day, and was asked to return in a week if her condition did not improve. The patient returned to the clinic 8 weeks later for a previously scheduled appointment and reported having experienced a dramatic response to celecoxib. Her depression had remitted rapidly, and the patient scored 0/27 on the PHQ-9. The patient reported an additional benefit of improved interpersonal interactions. Her depression resolved when treated with celecoxib, and the patient continued to feel better on celecoxib. The authors commented that, "We discussed the possibility that her depression might be a reaction to the flu vaccine. On the assumption that her relapse of depression was related to an immune response, we agreed to a trial of celecoxib 200 mg twice/d, and she was asked to return in a week if her condition did not improve. This patient experienced a rapid relapse of her bipolar depression within a couple of hours after receiving a seasonal flu vaccine injection. Her depression resolved when treated with celecoxib, and she continues to feel better on celecoxib. This case seems to be consistent with a recent report of celecoxib improving treatment-resistant bipolar depression. Should our bipolar patients experience vaccination-induced relapse of depression, adding celecoxib to their treatment regimen could be helpful." The article corresponding to this case is not available for regulatory submission due to copyright restriction.