Age: 28.0
Sex: F
Vaccine: FLUC3, TDAP
Symptoms: Condition aggravated, Exposure during pregnancy, Fatigue, Fibromyalgia, Laboratory test normal
Clinical narrative: Fibromyalgia flare up -specific fatigue and increased widespread pain; Increased widespread pain; Sensitivity to cold on joints; Increased migraine tendency after flucelvax; migraines while pregnant; Patient was vaccinated with Flucelvax Quadrivalent at 21st week of pregnancy; This spontaneous case was received on 23-Jan-2024 from other non-healthcare professional (consumer) via Med Communications (reference number: SEQW24-00353) and concerned a 28-year-old, pregnant, female patient.  The patient's concurrent conditions included fibromyalgia, thrombocytopenia, polyarthritis and migraine (also reported as 'migraines while pregnant'). The patient's concomitant medications included magnesium, krill oil, Vitafol ultra (docosahexaenoic acid, minerals nos, vitamins nos), Vitamin k2 mk7 (menaquinone-7), vitamin D3, Tylenol (paracetamol), sumatriptan, ondansetron, l-carnitine, l-theanine, curcumin, lysine and Coq10 (ubidecarenone), all used for an unreported indication.   The patient's last menstrual period (LMP) was 27-Apr-2023 and estimated delivery date (EDD) was 30-Jan-2024. The patient's obstetrical history noted that this was first pregnancy. At the time of reporting, infant gestational age was 39 weeks, as reported. The patient's corrected estimated date of delivery (CEDD) and type of pregnancy was not reported.  On 26-Sep-2023, at 21st week of pregnancy (also reported as '22 weeks pregnant'), the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) as active immunization against influenza disease, as reported (explicitly coded to 'Vaccine exposure during pregnancy'). The batch number not reported.  On 27-Sep-2023, one day after receiving the Flucelvax Quadrivalent, the patient experienced increased migraine tendency, also reported as on 29-Sep-2023, 11-Oct-2023, 22-Oct-2023, 07-Nov-2023, 26-Nov-2023 and on 23-Dec-2023.  On 25-Oct-2023, at 25th week of pregnancy (also reported as '26 weeks and 1 day pregnant'), the patient was vaccinated with non-company, co-suspect Tdap (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid; dose, route of administration, anatomical location, and indication: not reported). The batch number not reported.  On 26-Oct-2023, one month after receiving Flucelvax Quadrivalent and one day after receiving non-company, co-suspect Tdap, the patient experienced fibromyalgia flare up - specific fatigue, increased widespread pain and sensitivity to cold on joints. Treatment measure associated with event was rest, as reported.  On an unspecified date, prenatal test revealed no defect or any other adverse finding.  The outcome of the events was not reported. The event of 'pain' was reduced back to manageable levels, as reported.  The reporter did not provide causality assessment. The reporter only stated that increased migraine tendency was after Flucelvax Quadrivalent and fibromyalgia flare up after Tdap vaccine.  The case was assessed as non-serious.  Company comment: A 28-year-old pregnant female patient with a history of fibromyalgia, thrombocytopenia, polyarthritis and migraine was vaccinated with Flucelvax Quadrivalent at 21st week of gestation (explicitly coded as: 'Vaccine exposure during pregnancy'). One day after the vaccination, the patient experienced increased migraine tendency in the following weeks. At 25th week of pregnancy, the patient was also vaccinated with non-company, co-suspect Tdap. One month after receiving the suspect product and one day after receiving non-company co-suspect vaccine, the patient experienced fibromyalgia flare up-specific fatigue, increased widespread pain and sensitivity to cold on joints. The patient's last menstrual period (LMP) was 27-Apr-2023 and estimated delivery date (EDD) was 30-Jan-2024. The patient's obstetrical history noted that this was first pregnancy. At the time of reporting, infant gestational age was 39 weeks, as reported. The patient's corrected estimated date of delivery (CEDD) and type of pregnancy was not reported. Relevant laboratory and diagnostic results were not provided. Due to plausible temporal relationship, causality for migraine is assessed as possibly related. Fibromyalgia, pain and temperature intolerance are assessed as not related, due to temporal implausibility as well as concurrent medical conditions and co-suspect vaccine as confounders. Vaccine exposure during pregnancy is assessed as not related as per company's specific guidelines.; Reporter's Comments: The reporter only stated that increased migraine tendency was after Flucelvax Quadrivalent and fibromyalgia flare up after Tdap vaccine.; Sender's Comments: A 28-year-old pregnant female patient with a history of fibromyalgia, thrombocytopenia, polyarthritis and migraine was vaccinated with Flucelvax Quadrivalent at 21st week of gestation (explicitly coded as: 'Vaccine exposure during pregnancy'). One day after the vaccination, the patient experienced increased migraine tendency in the following weeks. At 25th week of pregnancy, the patient was also vaccinated with non-company, co-suspect Tdap. One month after receiving the suspect product and one day after receiving non-company co-suspect vaccine, the patient experienced fibromyalgia flare up-specific fatigue, increased widespread pain and sensitivity to cold on joints. The patient's last menstrual period (LMP) was 27-Apr-2023 and estimated delivery date (EDD) was 30-Jan-2024. The patient's obstetrical history noted that this was first pregnancy. At the time of reporting, infant gestational age was 39 weeks, as reported. The patient's corrected estimated date of delivery (CEDD) and type of pregnancy was not reported. Relevant laboratory and diagnostic results were not provided. Due to plausible temporal relationship, causality for migraine is assessed as possibly related. Fibromyalgia, pain and temperature intolerance are assessed as not related, due to temporal implausibility as well as concurrent medical conditions and co-suspect vaccine as confounders. Vaccine exposure during pregnancy is assessed as not related as per company's specific guidelines.