Age: 58.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Dry mouth, Hypoaesthesia, Insomnia, Nasal congestion, Pollakiuria
Clinical narrative: Bruising at injection site - after the injection; Nasal congestion; Insomnia; Dry mouth in the night; Less but higher FRQ urine; Numbing in her fingers; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising at injection site - after the injection), NASAL CONGESTION (Nasal congestion), INSOMNIA (Insomnia), DRY MOUTH (Dry mouth in the night) and POLLAKIURIA (Less but higher FRQ urine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products DUPILUMAB for Nasal polyps and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    No Medical History information was reported.   On 19-Oct-2020, the patient started DUPILUMAB (Subcutaneous) 300 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) (unknown route) at an unspecified dose. On 19-Oct-2020, the patient experienced VACCINATION SITE BRUISING (Bruising at injection site - after the injection), NASAL CONGESTION (Nasal congestion), INSOMNIA (Insomnia), DRY MOUTH (Dry mouth in the night), POLLAKIURIA (Less but higher FRQ urine) and HYPOAESTHESIA (Numbing in her fingers). At the time of the report, VACCINATION SITE BRUISING (Bruising at injection site - after the injection), NASAL CONGESTION (Nasal congestion) and INSOMNIA (Insomnia) had not resolved and DRY MOUTH (Dry mouth in the night), POLLAKIURIA (Less but higher FRQ urine) and HYPOAESTHESIA (Numbing in her fingers) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant product use was not provided by the reporter.  On 19-Oct-2020, the patient started taking subcutaneous dupilumab injection at a dose of 300 mg every other week (strength: 300 mg/2ml, lot number and expiration date: unknown) for nasal polyps delivered via dupilumab prefilled pen. In the context of COVID19 crisis, the batch number and expiration date were not requested. It was the first time use of the product. On 19-Oct-2020 (latency: same day), after the injection, the patient experienced bruising at the injection site (Injection site bruising). Upon follow up it was reported that patient had complained that dupixent caused dry mouth in the night (dry mouth), numbing in her fingers (hypoaesthesia), less but higher FRQ urine (pollakiuria) (onset and latency unknown for all events). The patient had nasal congestion for a few months (onset and latency unknown). The patient also had insomnia since starting dupilumab (insomnia) (onset and latency unknown). MD was aware.  No lab tests reported.  Action taken for dupilumab: no action taken for injection site bruising, unknown for all others.   No corrective treatment was received for injection site bruising, unknown for all others.  Reporter causality for dupilumab: Related for dry mouth in the night, numbing in her fingers and less but higher FRQ urine and not reported for injection site bruising.  Additional information received on 20-oct-2021 from patient via specialty pharmacy: Added event, dry mouth, numbness in fingers, increased urinary frequency.   Additional information received on 20-Nov-2021 from patient via specialty pharmacy: Added events of nasal congestion and insomnia.  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.