Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective
Clinical narrative: COVID-19; Lack of efficacy; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Flu vaccine. Past adverse reactions to the above products included Vaccination adverse reaction with Flu vaccine. Concurrent medical conditions included Cold sores, Fibromyalgia and Chronic pain. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Chronic pain, LYSINE for Cold sores, DULOXETINE and GABAPENTIN for Fibromyalgia, MULTIVITAMIN [VITAMINS NOS], CALCIUM, MAGNESIUM and COLISTIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with LISINOPRIL ongoing since an unknown date for Blood pressure high, at an unspecified dose and frequency; AVENA SATIVA FLUID EXTRACT (AVEENO) for Itching, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) blood pressure was running a little higher than usual.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   About 6-7 years ago, when the H1N1 was around, the patient had a reaction to that flu shot. The patient missed a day of work after the flu shot. The patient still gets the regular flu vaccine in a high dose.  Treatment medications also includes monoclonal antibodies and ice.  Company comment: This case concerns a 71-years-old female patient, with no relevant medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 8 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  It has also been reported that the patient received the booster dose. Further information received states that the patient had a mild case of COVID-19 and received monoclonal antibodies.  No other relevant information was disclosed.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-416066 (Patient Link).; Sender's Comments: This case concerns a 71-years-old female patient, with no relevant medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 8 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  It has also been reported that the patient received the booster dose. Further information received states that the patient had a mild case of COVID-19 and received monoclonal antibodies.  No other relevant information was disclosed.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.