Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Arm is sore on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is sore on the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Dermatitis atopic and Asthma.    The patient's past medical history included COVID-19 (symptoms lasted for a full 2 weeks. Recovered completely.) in December 2020. Concurrent medical conditions included Asthma. Concomitant products included BORON, ASCORBIC ACID, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN SODIUM PHOSPHATE, THIAMINE HYDROCHLORIDE, LITHIUM CARBONATE and MAGNESIUM for an unknown indication.   On 19-Sep-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On 26-Nov-2019, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced VACCINATION SITE PAIN (Arm is sore on the injection site). At the time of the report, VACCINATION SITE PAIN (Arm is sore on the injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 19-Sep-2019, the patient started taking DUPIXENT (DUPILUMAB) via prefilled syringe at 600 mg once loading dose subcutaneous, followed by 300mg maintenance every other week since 26-Nov-2019 (with an unknown batch number, strength and formulation) for Dermatitis atopic and Asthma.  On the unknown date of Dec-2020, after the unknown latency of starting the treatment with Dupilumab, patient experienced Covid-19 infection (Covid-19). Initially she thought that it was thought it was just bronchitis, and she treated it with natural remedies that she uses for her breathing and had to use her asthma inhaler and little bit more than she normally would, but she generally has to use her asthma inhaler only minimally. Patient stated that within a few days she suspected Covid-19, and she did test positive for it. Patient stated that her symptoms were like those of bronchitis, and also extreme fatigue so that she was sleeping a lot of the time (Somnolence), extreme weakness (asthenia), nausea, and lack of appetite (decreased appetite). Patient stated that her Covid-19 symptoms lasted for a full 2 weeks, and then she recovered completely, and she has not experienced any "long-haul" Covid-19 symptoms. Patient stated that one of her doctors told her that Dupixent may actually have helped to prevent her Covid-19 symptoms from getting any worse.  On 01-Oct-2021, the patient received a dose of suspect MODERNA COVID-19 VACCINE in the arm. On 02-Oct 2021, the patient noticed her arm was sore on the injection site (injection site pain). Her last dose of Dupixent was on 22-Sep-2021. At the time of the report, Dupixent was continued. Treatment detail for injection site pain was not provided.  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.