Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Muscle spasms, Myalgia, Pulmonary congestion, Pyrexia
Clinical narrative: Mucus in the lungs after 2nd dose; Muscle cramps after 2nd dose; Diarrhea after 2nd dose; Loss of sense of taste after 2nd dose; Loss of sense of smell after 2nd dose; Coughing after 2nd dose; Sciatica got worst after 2nd dose; COVID-19; lack of drug effect; Fever 100.1F after 2nd dose; Muscle aches after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Mucus in the lungs after 2nd dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 13A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced PULMONARY CONGESTION (Mucus in the lungs after 2nd dose) (seriousness criterion medically significant), MUSCLE SPASMS (Muscle cramps after 2nd dose), DIARRHOEA (Diarrhea after 2nd dose), AGEUSIA (Loss of sense of taste after 2nd dose), ANOSMIA (Loss of sense of smell after 2nd dose), COUGH (Coughing after 2nd dose), SCIATICA (Sciatica got worst after 2nd dose), COVID-19 (COVID-19), DRUG INEFFECTIVE (lack of drug effect), PYREXIA (Fever 100.1F after 2nd dose) and MYALGIA (Muscle aches after 2nd dose). At the time of the report, PULMONARY CONGESTION (Mucus in the lungs after 2nd dose), MUSCLE SPASMS (Muscle cramps after 2nd dose), DIARRHOEA (Diarrhea after 2nd dose), AGEUSIA (Loss of sense of taste after 2nd dose), ANOSMIA (Loss of sense of smell after 2nd dose), COUGH (Coughing after 2nd dose), SCIATICA (Sciatica got worst after 2nd dose), COVID-19 (COVID-19), DRUG INEFFECTIVE (lack of drug effect), PYREXIA (Fever 100.1F after 2nd dose) and MYALGIA (Muscle aches after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, SARS-CoV-2 test: positive positive (Positive) positive..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported  Company comment - This case concerns a 65-year-old, female patient with no reported medical history. The patient experienced serious (medically significant) event of Pulmonary congestion and non-serious events of Covid-19, Muscle spasm, diarrhea, ageusia, anosmia, cough, sciatica, pyrexia and myalgia 6 months and 25 days after second dose of Spikevax. The events causality was not provided by reporter. The rechallenge is not applicable, as these events related to COVID-19 patient experienced 6 months and 25 days after second dose of Spikevax. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD21-119328, MOD21-136027 (Patient Link).; Sender's Comments: This case concerns a 65-year-old, female patient with no reported medical history. The patient experienced serious (medically significant) event of Pulmonary congestion and non-serious events of Covid-19, Muscle spasm, diarrhea, ageusia, anosmia, cough, sciatica, pyrexia and myalgia 6 months and 25 days after second dose of Spikevax. The events causality was not provided by reporter. The rechallenge is not applicable, as these events related to COVID-19 patient experienced 6 months and 25 days after second dose of Spikevax. The benefit-risk relationship of Spikevax is not affected by this report.