Sex: F
Vaccine: COVID19
Symptoms: Abnormal menstrual clots, Brain fog, Fatigue, Headache, Heavy menstrual bleeding
Clinical narrative: Abnormal menstrual clots; Heavy menstrual bleeding; Brain fog; Stress at work; intermenstrual bleeding; Headache; Somnolence; Injection site pain; Fatigue; polymenorrhoea; This is a spontaneous report received from a Consumer or other non HCP from License Party.  Initial information received on 15Aug2024 (live follow up received on 19Aug2024, both processed together) regarding a solicited valid non-serious case received from the patient, in the scope of patient support program  This case involved a 41-year-old female patient who reported pen was painful, felt fatigued after her last injection, her menstrual cycle came early one month, had menstrual issues/extended period, some spotting over the weekend, had heavy flow with blood clotting, headache, grogginess the day of injection, brain fog and work related stress while being treated with Duplumab [Dupixent] via Dupixent single dose prefilled pen and while receiving vaccine COVID-19 VACCINE. The patient stated last 2 injections were about 7 days apart, due to a missed dose, and had taken the doses closer together and not the 14 days apart with no reported adverse event which is directly related to inappropriate schedule of product administration. The patient's past medical history included Myomectomy and Uterine leiomyoma. The patient's past medical treatment(s), concomitant medications, concomitant diseases (or) any risk factors and family history were not provided. On 06Jun2024, the patient started taking DUPIXENT (DUPILU MAB) Solution for injection (strength: 300mg/2ml) at a dose of 300 mg QOW subcutaneously for intrinsic (allergic) eczema. On Jun2024 the patient had a non-serious event "headache" few days approximately latency following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and (unknown latency) following the administration of COVID-19 VACCINE. On Jun2024 the patient had a non-serious event "grogginess the day of injection" (somnolence) few days approximately latency following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and (unknown latency) following the administration of COVID-19 VACCINE. On 21Aug2024 the patient had a non-serious event "menstrual issues/ having extended period with heavy gush" (heavy menstrual bleeding) 2 months 15 days following the first dose intake (unknown batch number and expiry date) of DUPILUM AB and (unknown latency) following the administration of COVID-19 VACCINE. In Aug2024 the patient had a non-serious event "some spotting over the weekend" (intermenstrual bleeding) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILU MAB and (unknown latency) following the administration of COVID-19 VACCINE. On 29Aug2024 the patient had a non-serious event "heavy flow with blood clotting" (abnormal menstrual clots) 2 months 23 days following the first dose intake (unknown batch number and expiry date) of DUPILUM AB and (unknown latency) following the administration of COVID-19 VACCINE. In Aug2024 the patient had a non-serious event "work related stress" (stress at work) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUM AB and (unknown latency) following the administration of COVID-19 VACCINE. In 2024 the patient had a non-serious event "event her menstrual cycle did come early one month" (polymenorrhoea) unknown latency following the first dose intake (unknown batch number and expiry date) of DUPILU MAB and (unknown latency) following the administration of COVID-19 VACCINE.In 2024 the patient developed a non-serious event "pen is painful" (injection site pain) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILU M AB and (unknown latency) following the administration of COVID-19 VACCINE. In 2024 the patient developed a non-serious event "felt fatigued after her last injection" (fatigue) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUM AB and (unknown latency) following the administration of CO VID-19 VACCINE. In 2024 the patient had a non-serious event "brain fog" (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILUMAB and (unknown latency) following the administration of COVID-19 VACCINE. In 2024 the patient had a non-serious event "brain fog" (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILU MAB and (unknown latency) following the administration of COVID-19 VACCINE. In 2024 the patient had a non-serious event "last 2 injections were about 7 days apart, due to a missed dose, and having taken the doses closer together and not the 14 days apart with no reported adverse event" (inappropriate schedule of product administration) (unknown latency) following the first dose intake (unknown batch number and expiry date) of DUPILU MAB and (unknown latency) following the administration of COVID-19 VACCINE. Information on batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "she felt fatigued after her last injection, which she did not feel with the pens. Upon follow up patient stated she was having menstrual issues with Dupixent. She was having extended period and heavy gushing. Pharmacists notes: Patient reported that since starting Dupixent in June, she had mostly tolerated therapy well but did have a headache and grogginess the day of injection. She stated the symptoms typically go away within 2-3 days. She confirmed that the last 2 injections were about 7 days apart, due to a missed dose, and patient believed she might be experiencing issues due to having taken the doses closer together and not the 14 days apart. Patient reported that she gave a dose last Friday 23Aug24 and that she had her usual brain fog over the weekend that went away by Monday 26Aug24. Patient reported she experienced a bad headache on Tuesday, which subsided with rest. Patient also confirmed it was her first week back teaching and she was under a lot of work related stress as well. She reported that her menstrual cycle began last Wednesday (Wednesday before her injection 21-aug-24) and that Friday (day of Dupixent injection) was the day of her heaviest flow. Patient stated that over the weekend, she had some spotting but period had mostly stopped up until Tuesday. She confirmed Wednesday of this week, she thought menstrual cycle was completely gone. Yesterday while getting her hair done, trying to relax, she felt a heavy gush and confirmed she was experiencing a heavy flow with blood clotting. Patient states that this morning, she noticed a large blood clot and a little blood gushing, not as bad as yesterday. Patient confirmed she was in tune with her body and could feel that her period was not over, even though she thought it was earlier in the week. Patient confirmed having normal menstrual cycles, she monitored on an app on her phone. Patient also reported she had history of uterine fibroids, which she had surgery for removal and since had light periods over the last year. Patient stated that since being on Dupixent, her menstrual cycle did come early one month, but she figured it was due to nerves, Patient stated her body responded strongly to stress and things such as medication and the COVID vaccine also caused her period to be heavier than normal. Patient reported that she did not think these things are hormone related, but that any form of stress on her body causes her pelvic floor to react in a different way. Pharmacist educated that there was not a lot of clinical data that supports Dupixent and effect on menstrual cycle, and that she should reach out to her OBGYN (obstetrician gynecologist) to discuss her symptoms. No further information reported". Action taken: No action taken for all the events for duplumab and not applicable for Covid-19 Vaccine for all the events. Corrective treatment: Not reported for all the events. Outcome: Unknown for the events injection site pain, fatigue, intermenstrual bleeding, poly menorrhoea and stress at work; Recovered / Resolved on 26Aug2024 for the event brain fog: Not Recovered / Not Resolved for the event heavy menstrual bleeding, headache, somnolence, abnormal menstrual clots.  Reporter causality: related for injection site pain and unassessable for rest events.  Company causality: reportable for injection site pain and not reportable for rest events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Additional information was received on 30Aug2024 from the patient: New events inter menstrual bleeding, polymenorrhoea, stress at work, brain fog, heavy menstrual bleeding, headache, somnolence, abnormal menstrual clots, inappropriate schedule of product administration were added. Strength, clinical course updated. Text amended accordingly.  (BNT162b2) is under agreement with (LLP-BIONTECH SE)