Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 antibody test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Few days ago, she couldn't speak), AGEUSIA (couldn't taste anything), PAIN (She has pain when coughing), BRONCHITIS (acute bronchitis) and COVID-19 (testing positive for COVID-19) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Ehlers-Danlos syndrome (she could not make collagen). Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), ASCORBIC ACID, ZINC (VITAMIN C + ZINC) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced AGEUSIA (couldn't taste anything), BRONCHITIS (acute bronchitis), DIZZINESS (dizzy), NAUSEA (nauseating) and HEADACHE (horrible headache). On 03-Jan-2022, the patient experienced COVID-19 (testing positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced APHONIA (Few days ago, she couldn't speak), PAIN (She has pain when coughing), MYALGIA (achy all over) and FATIGUE (fatigue). The patient was treated with DOXYCYCLINE for Adverse event, at an unspecified dose and frequency; SALBUTAMOL for Adverse event, at an unspecified dose and frequency; OXYGEN for Adverse event, at a dose of, She is using oxygen at home and OXYMETAZOLINE HYDROCHLORIDE (DECONGESTANT [OXYMETAZOLINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 16-Jan-2022, COVID-19 (testing positive for COVID-19) had resolved. At the time of the report, APHONIA (Few days ago, she couldn't speak) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and AGEUSIA (couldn't taste anything), PAIN (She has pain when coughing), BRONCHITIS (acute bronchitis), DIZZINESS (dizzy), NAUSEA (nauseating), MYALGIA (achy all over), FATIGUE (fatigue) and HEADACHE (horrible headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 antibody test: positive (Positive) Positive. On 16-Jan-2022, SARS-CoV-2 antibody test: negative (Negative) negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medication also includes Steroid 4mg dose pack for 6 days. Patient reported pre-existing condition Ehlers Danlos Syndromes (life long genetic condition) where she could not make collagen. She is not taking any long term medication for her condition, only on Tylenol, vitamin C and zinc and multivitamins. Patient reported Horrible headache, dizzy, nauseating, couldn't taste anything, acute bronchitis 3 weeks before testing positive for COVID-19. Company comment: This Spontaneous case concerns a 76-year-old, female patient, with no relevant medical history, who experienced the unexpected, non-serious and AESI of COVID-19 and ageusia, among others. Drug ineffective was also reported. The patient developed COVID-19 approximately 9 months and 23 days after receiving the second dose of mRNA-1273 vaccine. It was reported that the first dose of her COVID-19 vaccination schedule was mRNA-1273 vaccine as well. She received doxycycline, salbutamol, oxymetazoline and oxygen as treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This Spontaneous case concerns a 76-year-old, female patient, with no relevant medical history, who experienced the unexpected, non-serious and AESI of COVID-19 and ageusia, among others. Drug ineffective was also reported. The patient developed COVID-19 approximately 9 months and 23 days after receiving the second dose of mRNA-1273 vaccine. It was reported that the first dose of her COVID-19 vaccination schedule was mRNA-1273 vaccine as well. She received doxycycline, salbutamol, oxymetazoline and oxygen as treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.