Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blood pressure measurement, COVID-19, Computerised tomogram, Influenza
Clinical narrative: cough, low grade fever low grade fever like 100 or a little higher and keeps going up and down, congestion, sneezing; got urinary pressure and is urinating a lot in it; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY SYMPTOM (cough, low grade fever low grade fever like 100 or a little higher and keeps going up and down, congestion, sneezing ) and URINARY TRACT INFECTION (got urinary pressure and is urinating a lot in it) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.      Concurrent medical conditions included Diabetes mellitus since 2005, Eczema, Seasonal allergy and Cough. Concomitant products included LISINOPRIL, METOPROLOL TARTRATE (LOPRESSOR), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and INSULIN for an unknown indication.   On 13-May-2021, the patient started DUPILUMAB (Subcutaneous) 600 milligram. On 27-May-2021, DUPILUMAB (Subcutaneous) dosage was changed to 300 milligram. On 29-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started METOPROLOL TARTRATE (unknown route) at an unspecified dose, MONTELUKAST SODIUM (unknown route) at an unspecified dose and ESCITALOPRAM OXALATE (unknown route) at an unspecified dose. On 29-Nov-2021, the patient experienced RESPIRATORY SYMPTOM (cough, low grade fever low grade fever like 100 or a little higher and keeps going up and down, congestion, sneezing ) (seriousness criterion medically significant) and URINARY TRACT INFECTION (got urinary pressure and is urinating a lot in it) (seriousness criterion medically significant). At the time of the report, RESPIRATORY SYMPTOM (cough, low grade fever low grade fever like 100 or a little higher and keeps going up and down, congestion, sneezing ) and URINARY TRACT INFECTION (got urinary pressure and is urinating a lot in it) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Angiogram: she may need an old fashion cardiac cath. In 2021, Computerised tomogram: she may need an old fashion cardiac cath. On 15-Aug-2021, Blood pressure measurement: 110/75. On an unknown date, Angiogram: two blockages one in the back and one in front. On an unknown date, COVID-19: Negative. On an unknown date, Computerised tomogram: two blockages one in the back and one in front. On an unknown date, Influenza: Negative. On an unknown date, SARS-CoV-2 test: Negative.         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.  On 13-May-2021, the patient started taking dupilumab, solution for injection, initial loading dose of 600mg once, subcutaneously (strength: 150mg/ml, batch number: 0F020A and expiry date: 31-Oct-2022) followed by 300mg every other week maintenance dose on 27-May-2021, maintenance dose, subcutaneously, every other week (lot number: 1F060A and expiry date: unknown) delivered single dose pre-filled syringe for eczema, dermatitis, unspecified (product use in unapproved indication, latency: same day) and atopic dermatitis unspecified. The nurse reported that she asked if patient had a needle disposal container for her used syringes, but patient said she disposes it in a milk carton that she tapes up and puts in the regular garbage, so she was told by nurse never to dispose her used needles in the regular garbage and told her that she will be sending her a sharps container and whatever needles she already had in the milk carton should be kept and transferred to the sharps container. The nurse also stated that she told the patient there will be a label inside the sharps container once it is full and how to send it to the waste disposal, with the patient agreeing not to do it anymore. At the time of report, patient used this product for the first time. It was unknown whether the patient allows a minimum of 45 minutes for the pen to come to room temperature after removal of the product from the refrigerator prior to use.   the patient as diagnosed with two blockages (Atrioventricular block, medically significant), one blockage in the front and the on her in the back of the heart. The patient's blood pressure on 15-Aug-2021 was 110/ 75 so she planned to call and discuss her blood pressure medications. The patient's cardiologist told her she may need an angiogram in the future and may also need bypass surgery.; Sender's Comments: This spontaneous case concerns 66-years-old female patient with concurrent condition of Diabetes mellitus, and dermatitis treated with DUPILUMAB and METOPROLOL TARTRATE, MONTELUKAST SODIUM and ESCITALOPRAM OXALATE, who experienced the unexpected serious (medically significant) events of Respiratory symptom and Urinary tract infection, which occurred on same day after receiving a dose of mRNA-1273 vaccine. The lab reports revealed that Computerized tomogram with two blockages one in the back and one in front and Influenza, SARS-CoV-2 test were Negative. The co-suspect could be the risk factor for the events. The concurrent condition of diabetes mellitus remains the confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.