Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertonic bladder, Malaise, Pain, Premature menopause, Pyrexia
Clinical narrative: sweating profusely, to where her hair was getting soaked/increased sweating; early menopause; overactive bladder; diarrhea; fever/raised temperature; Chills; felt bad/feeling lousy; general malaise,feeling sick times two and a half days/malaise; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad/feeling lousy), MALAISE (general malaise,feeling sick times two and a half days/malaise), PAIN (body aches), HYPERHIDROSIS (sweating profusely, to where her hair was getting soaked/increased sweating) and PREMATURE MENOPAUSE (early menopause) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Immunization. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DUPILUMAB solution for injection for Dermatitis atopic and DUPILUMAB (DUPIXENT) solution for injection for Dermatitis atopic.    The patient's past medical history included Surgery. Concurrent medical conditions included Eczema. Concomitant products included OXYBUTYNIN for Eczema.   In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient started DUPILUMAB (Subcutaneous) 600 milligram once a day. On 03-Sep-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced FEELING ABNORMAL (felt bad/feeling lousy), MALAISE (general malaise,feeling sick times two and a half days/malaise), PAIN (body aches), DIARRHOEA (diarrhea), PYREXIA (fever/raised temperature) and CHILLS (Chills). On an unknown date, the patient experienced HYPERHIDROSIS (sweating profusely, to where her hair was getting soaked/increased sweating), PREMATURE MENOPAUSE (early menopause) and HYPERTONIC BLADDER (overactive bladder). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt bad/feeling lousy), MALAISE (general malaise,feeling sick times two and a half days/malaise), PAIN (body aches), DIARRHOEA (diarrhea) and PYREXIA (fever/raised temperature) had not resolved and HYPERHIDROSIS (sweating profusely, to where her hair was getting soaked/increased sweating), PREMATURE MENOPAUSE (early menopause), HYPERTONIC BLADDER (overactive bladder) and CHILLS (Chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Body temperature: Raised.         Onset latency was approximately 3 months for the events (chills, malaise, feeling abnormal, pyrexia, pain, diarrhoea).  The patient stated she was sweating profusely, to where her hair was getting soaked. She had gone through early menopause and had noticed that she had this same effect with a previous medication. Patient reports AE (adverse event) of increased sweating, and overactive bladder. Patient had a history of multiple surgeries, and med list is current. Patient had a reaction to oxybutynin and that may have caused her initial eczema. Patient was just starting Dupixent. Patient received Covid booster shot on Friday and was not prescribed by her HCP. She had a reaction after the booster shot she had for 2 days on Saturday and Sunday. She felt better on Monday and took her injection on Tuesday. Now she still feeling lousy. She was wondering if it that was side effect of Dupixent or the Covid booster shot. she reported that her symptoms are still ongoing. The patient was treated with paracetamol (Tylenol) for Pain, Malaise and Pyrexia.  Reporter causality: unassessable for hyperhidrosis, premature menopause, hypertonic bladder for dupilumab via prefilled pen and not reported for all the events for dupilumab via prefilled syringe.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.