Age: 21.0
Sex: F
Vaccine: HEP, HEPA, HPVX, MEN, MEN, MEN, MMR, PNC13, TDAP, UNK, UNK, UNK, UNK, UNK
Symptoms: Negative thoughts, Poor quality sleep, Somnolence, Stress, Suicidal ideation
Clinical narrative: Vitamin D low; Stress she feels that it gets worse; Depression; Bad breath/ Halitosis; Gender dysphoria; Gastroesophageal reflux disease without esophagitis; stomach pain; bad thoughts; extremely drowsy/making her sleepy; Dysplasia of anus; Suicidal; light headed; having Fatigue/feels tired; muscle pains; hypersomnia; poor sleep waking up multiple times; This serious case was reported by a physician via patient support programs and described the occurrence of anal dysplasia in a 31-year-old female patient who received bupropion hydrochloride (Wellbutrin) film-coated tablet for depression.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis, Hepatitis A vaccine for prophylaxis, Men B NVS (Meningococcal B vaccine) for prophylaxis, Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis, Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis, HPV 16-18 (HPV vaccine) for prophylaxis, MMR (MMR vaccine) for prophylaxis, Hepatitis B vaccine for prophylaxis, pneumococcal vaccine conj 13v (crm197) (Prevenar 13) for prophylaxis, escitalopram oxalate (Lexapro) for depression, duloxetine hydrochloride (Cymbalta) for product used for unknown indication, sertraline hydrochloride (Zoloft) for product used for unknown indication and cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate (Genvoya) tablet for hiv infection.   The patient's past medical history included vaginoplasty, anorectal operation (for dysplasia), removal of wisdom teeth and nonsmoker (No known Drug allergy, ETOH: None, Drugs MJ, last used 2019). Previously administered products included stribild with an associated reaction of no adverse event. Concurrent medical conditions included hiv infection and lumbar disc herniation. Additional patient notes included Other conditions unknown.. Family history included joint pain (Father: alive, unknown) and intervertebral disc protrusion (Mother: alive).   On an unknown date, the patient started Wellbutrin. On 20-MAR-2014, the patient received Tdap Vaccine. On an unknown date, the patient received Hepatitis A vaccine. On 17-OCT-2017, the patient received Meningococcal B vaccine. On 20-FEB-2014, the patient received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On 10-DEC-2013, the patient received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On an unknown date, the patient received HPV vaccine, MMR vaccine and Hepatitis B vaccine. On 10-DEC-2013, the patient started Prevenar 13. On an unknown date, the patient started Lexapro, Cymbalta, Zoloft and Genvoya (oral) 1 dosage form(s) daily (1 dosage form(s) daily). The dose was changed to 1 dosage form(s) daily (1 dosage form(s) daily). The dose was changed to 1 dosage form(s) daily (1 dosage form(s) daily). In MAR-2024, an unknown time after starting Wellbutrin and an unknown time after receiving Tdap Vaccine, Hepatitis A vaccine, Meningococcal B vaccine, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, HPV vaccine, MMR vaccine and Hepatitis B vaccine, the patient experienced muscle pain (Verbatim: muscle pains), hypersomnia (Verbatim: hypersomnia), poor sleep (Verbatim: poor sleep waking up multiple times) and fatigue (Verbatim: having Fatigue/feels tired). On an unknown date, the patient experienced anal dysplasia (Verbatim: Dysplasia of anus) (serious criteria GSK medically significant), suicidal tendency (Verbatim: Suicidal) (serious criteria GSK medically significant), light headedness (Verbatim: light headed), vitamin d low (Verbatim: Vitamin D low), stress (Verbatim: Stress she feels that it gets worse), depression (Verbatim: Depression), breath odor (Verbatim: Bad breath/ Halitosis), gender dysphoria (Verbatim: Gender dysphoria), gastroesophageal reflux disease (Verbatim: Gastroesophageal reflux disease without esophagitis), stomach pain (Verbatim: stomach pain), abnormal thinking (Verbatim: bad thoughts) and somnolence (Verbatim: extremely drowsy/making her sleepy). The patient was treated with estradiol and progesterone. The action taken with Wellbutrin was unknown. The action taken with Lexapro was unknown. Cymbalta was discontinued. The action taken with Zoloft was unknown. The action taken with Genvoya was unknown. The outcome of the anal dysplasia, muscle pain, hypersomnia, poor sleep, light headedness, fatigue, vitamin d low, stress, depression, breath odor, gender dysphoria, gastroesophageal reflux disease and stomach pain were unknown and the outcome of the suicidal tendency, abnormal thinking and somnolence were not reported.   It was unknown if the reporter considered the anal dysplasia, suicidal tendency, muscle pain, hypersomnia, poor sleep, light headedness, fatigue, vitamin d low, stress, depression, breath odor, gender dysphoria, gastroesophageal reflux disease, stomach pain, abnormal thinking and somnolence to be related to Wellbutrin, Tdap Vaccine, Hepatitis A vaccine, Meningococcal B vaccine, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, HPV vaccine, MMR vaccine and Hepatitis B vaccine.    It was unknown if the company considered the anal dysplasia, suicidal tendency, muscle pain, hypersomnia, poor sleep, light headedness, fatigue, vitamin d low, stress, depression, breath odor, gender dysphoria, gastroesophageal reflux disease, stomach pain, abnormal thinking and somnolence to be related to Wellbutrin, Tdap Vaccine, Hepatitis A vaccine, Meningococcal B vaccine, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, HPV vaccine, MMR vaccine and Hepatitis B vaccine.    GSK receipt date:20-MAR-2024 This report was submitted via the RA.History of Present Illness stated, Patient has been having fatigue for the past 2 weeks with muscle pains,hypersomnia, poor sleep- waking up multiple times throughout the night.She also said that she has been light headed and has had concentrating. With stress she feels that it gets worse, and feels particularly tired at the end of the work day and the drive home. Pt states that she has been feeling the fatigue long before the onset of the other symptoms. Denies fever, nausea. vomiting, falling. She felt the stress was not going to improve at all. She has been on mental health meds in the past.She knows she's been on Lexapro and Wellbutrin. She felt like one of them made her suicidal initially and another was constant stomach pains. She doesn't think she's been on Cymbalta or Effexor previously.The labs were mostly normal, other than mildly low Vitamin D. She was sleeping better and the pains are improved, but she is still very fatigued. She was willing to try the antidepressants, but she was worried about the bad thoughts and not being able to get off it.She only took the Cymbalta for a couple of days. It was causing her to be externally drowsy to the point she couldn't drive. So, she stopped. She feels every thing is okay right now and she doesn't want to try anything different.On 21-AUG-2023 she has started with psychiatry. she was diagnosed with depression and has been started on a low dose of Zoloft.It was making her sleepy, but it has only been about 1 week on it so far. She moved here in June 2020, but She moved from was going back and forth and ready to get all of her care here. She was diagnosed around 2014 and only got care there. She was initially on Stribild, but switched to Genvoya. Doing well on Genvoya, not having any issues. She was interested in Cabenuva.Method of Transmission of HIV was reported as likely sexual activity.CD4 nadir was reported as unknown.Genotype done was reported as Pamensitive. Lungs ha No audible wheezes. Speaking in complete sentences and unlabored. Normal Effort. Chest was Normal chest rise. Rectal was not examined. Musculoskeletal Gait was normal. Extremities normal extremity with no clubbing, cyanosis or edema,apparently full range of motion.Neurologic: cognitive exam grossly normal , cranial nerves grossly intact.Psych: alert and oriented x 3 , cooperative with exam , speech was clear and coherent , normal affect / mood , with good judgement and insight.1. Human immunodeficiency virus [HIV] disease - B20 (Primary), Continue Genvoya for now. would try to get Cabenuva approved.2. Gender dysphoria - F64-9, Continue as was.3. Dysplasia of anus - K62.82,4. Gastro-esophageal reflux disease without esophagitis - K21.9, suspect this was the cause of the bad breath. Advised to try OTC GERD meds would refer to Gl for further eval. 5. Halitosis - R19.6,suspect underlying GERD.advised she take OTC GERD medication while try to get into GI for evaluation.Preventive medicine of Hepatitis C screen included PPSV23: 21-FEB-2014, 30-AUG-2014. Influenza. Anal Pap smear:LSIL- referred to colorectal. Colonocsopy: Due age 45.HPV:Completed series 2014.Quantiferon Gold:Negative on APR-201. Others reported as Dental on JAN-2023.. Ophthalmology :referred 21-AUG-2023,Depression screen :Active depression- seeing psychiatry.Bad breath-she has been noticing bad breath since around March.No change to diet, no new medications or supplements around that time.She was not having any GERD that she has noticed. She saw a dentist earlier in the year, and everything was normal. General examinations reported as General appearance: alert, well-nourished and in no acute distress, Head: norm cephalic, atraumatic,Eyes: extraocular movement intact (EOM() , pupils equal.,Ears: Hearing was normal, Nose: nares patent , no lesions.Ora] cavity: normal , mucosa moist.Throat: pharynx normal tonsils normal uvula midline. Neck / thyroid: neck is supple, with full range of motion and no cervical lymphadenopathy , trachea midline, no visible lymphadenopathy, Skin: no suspicious skin lesions or rashes.Heart: Extremities well perfused. Other products were unknown. It was unknown if the reporter considered the anal dysplasia, suicidal tendency, muscle pain, hypersomnia, poor sleep, light headedness, fatigue, vitamin d low, stress, depression, breath odor, gender dysphoria, gastroesophageal reflux disease, stomach pain, abnormal thinking and somnolence to be related to Prevenar 13.; Sender's Comments:  US-GSK-US2024036447:Same reporter