Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: My strength builds a little more each day; Loss of appetite; Joint stiffened; Lack of efficacy; Covid symptoms: Nausea; Tested positive for Covid on 8 september, 2021 for corona virus; pyrexia; Breathing is challenged if i get up and move around a lot; Hypersensitivity reaction; Shot site swelled; Shot site red; Shot site itched; high-grade fever/Continued to run low grade temperature with some days going up to 100./ still running temperature; Arm hurt when moving it; Slept most of the day 2 to day 4; Shot site hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt when moving it), HYPERSOMNIA (Slept most of the day 2 to day 4), COVID-19 (Tested positive for Covid on 8 september, 2021 for corona virus), ASTHENIA (My strength builds a little more each day) and DYSPNOEA (Breathing is challenged if i get up and move around a lot) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017321A and 012A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypoglycaemia since 1998, Depression since 2002, Drug allergy (Sulpha drugs (rash)) since 2000, Grass allergy (Rash at site touched by grass/ sneezing) since 2000 and Insect sting allergy (swelling, run fever, bite turns red with a circle around bug bite) since 07-Jul-2003. Concomitant products included GLUCOSAMINE HYDROCHLORIDE, HYALURONIC ACID (SCHIFF GLUCOSAMINE) for Arthritis, CITALOPRAM for Depression, PREBIOTICS NOS, APPLE CIDER VINEGAR and AMYLASE, LIPASE, PEPSIN, TRYPSIN (MULTIENZYME) for Digestion impaired, VITAMINS NOS for Energy decreased, LECITHIN for High cholesterol, POTASSIUM, MAGNESIUM and COCONUT OIL for Ketogenic diet, PROGESTERONE for Menopause, ESTRADIOL for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (Arm hurt when moving it), HYPERSOMNIA (Slept most of the day 2 to day 4), VACCINATION SITE INDURATION (Shot site hard), VACCINATION SITE SWELLING (Shot site swelled), VACCINATION SITE ERYTHEMA (Shot site red) and VACCINATION SITE PRURITUS (Shot site itched). On 22-Apr-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On 08-Sep-2021, the patient experienced COVID-19 (Tested positive for Covid on 8 september, 2021 for corona virus), DECREASED APPETITE (Loss of appetite), JOINT STIFFNESS (Joint stiffened), DRUG INEFFECTIVE (Lack of efficacy) and NAUSEA (Covid symptoms: Nausea). In September 2021, the patient experienced DYSPNOEA (Breathing is challenged if i get up and move around a lot). On an unknown date, the patient experienced ASTHENIA (My strength builds a little more each day) and PYREXIA (high-grade fever/Continued to run low grade temperature with some days going up to 100./ still running temperature). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 22-Apr-2021 for Fever, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] for COVID-19, at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL ALLERGY SINUS) for COVID-19, at an unspecified dose and frequency. On 27-Apr-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt when moving it), HYPERSOMNIA (Slept most of the day 2 to day 4), VACCINATION SITE INDURATION (Shot site hard), VACCINATION SITE SWELLING (Shot site swelled), VACCINATION SITE ERYTHEMA (Shot site red) and VACCINATION SITE PRURITUS (Shot site itched) had resolved, COVID-19 (Tested positive for Covid on 8 september, 2021 for corona virus), DECREASED APPETITE (Loss of appetite), JOINT STIFFNESS (Joint stiffened) and NAUSEA (Covid symptoms: Nausea) was resolving, DYSPNOEA (Breathing is challenged if i get up and move around a lot) and PYREXIA (high-grade fever/Continued to run low grade temperature with some days going up to 100./ still running temperature) had not resolved and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 100 (High) Fever: 100 degrees. On 22-Apr-2021, SARS-CoV-1 test positive: positive (Positive) COVID-19 positive. On 23-Apr-2021, Body temperature: 101 (High) Fever: 101 degrees. On 24-Apr-2021, Body temperature: 101 (High) Fever: 101 degrees. On 25-Apr-2021, Body temperature: 100 (High) Fever: 101 degrees and 99 (High) Fever: 99 degrees. On an unknown date, Body temperature:.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PAIN IN EXTREMITY (Arm hurt when moving it), HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE INDURATION (Shot site hard), VACCINATION SITE SWELLING (Shot site swelled), VACCINATION SITE ERYTHEMA (Shot site red), VACCINATION SITE PRURITUS (Shot site itched) and PYREXIA (high-grade fever/Continued to run low grade temperature with some days going up to 100./ still running temperature) to be possibly related. No further causality assessments were provided for HYPERSOMNIA (Slept most of the day 2 to day 4), COVID-19 (Tested positive for Covid on 8 september, 2021 for corona virus), ASTHENIA (My strength builds a little more each day), DYSPNOEA (Breathing is challenged if i get up and move around a lot), DECREASED APPETITE (Loss of appetite), JOINT STIFFNESS (Joint stiffened), DRUG INEFFECTIVE (Lack of efficacy) and NAUSEA (Covid symptoms: Nausea).    On 08-Sep-2021, patient tested positive for COVID-19. Patient took infusion, antibiotics, steroids, two different inhalers and many vitamins. By tenth day of COVID-19 that is on18-SEP-2021 patient was able to get out of bed for a while and patient reports of building strength with each passing day. Patient is still running from a low grade fever and challenged breathing while getting up and moving around a lot.   This case was linked to MOD-2021-067429 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Significant: HCP reporter added, Initial reporter information added, Patient demographics added, Patient medical history information added, Lab tests added, Lot number for Dose 2,  Concomitants medications added, Treatment medication added, additional events added, Case outcome updated to not recovered/not resolved.; Sender's Comments: This case concerns a 56-year-old female patient with no relevant medical history, who experienced  non-serious  expected events (pyrexia, vaccination site swelling, vaccination site erythema) and the non-serious unexpected event COVID-19 . The expected events occurred approximately 2 days after the second dose and event COVID occurred more than 4 months after second  dose of mRNA-1273 Moderna vaccine. Event Drug ineffective was also captured. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.