Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sinusitis, Somnolence
Clinical narrative: allergy like symptoms; eyes nose ear itch; eyes nose ear itch; Ear itch; tingle in hands and feet; could not smell or taste; could not smell or taste; tip of tongue was numb; congestion in head, ear, feels like sinus infection; feels like sinus infection; cant hear very well, Feels virus in nervus.; congestion in head, ear, feels like sinus infection; Headache/Head hurt all over; pneumonia; Felt was sick; coughing; asthma; Naps; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (pneumonia) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant), MALAISE (Felt was sick), COUGH (coughing), ASTHMA (asthma), SOMNOLENCE (Naps), HYPERSENSITIVITY (allergy like symptoms), EYE PRURITUS (eyes nose ear itch), NASAL PRURITUS (eyes nose ear itch), PRURITUS (Ear itch), PARAESTHESIA (tingle in hands and feet), ANOSMIA (could not smell or taste), AGEUSIA (could not smell or taste), HYPOAESTHESIA ORAL (tip of tongue was numb), EAR CONGESTION (congestion in head, ear, feels like sinus infection), SINUSITIS (feels like sinus infection), HYPOACUSIS (cant hear very well, Feels virus in nervus.), NASAL CONGESTION (congestion in head, ear, feels like sinus infection) and HEADACHE (Headache/Head hurt all over). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE (ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE]) at an unspecified dose and frequency. At the time of the report, PNEUMONIA (pneumonia), MALAISE (Felt was sick), COUGH (coughing), ASTHMA (asthma), SOMNOLENCE (Naps), HYPERSENSITIVITY (allergy like symptoms), EYE PRURITUS (eyes nose ear itch), NASAL PRURITUS (eyes nose ear itch), PRURITUS (Ear itch), PARAESTHESIA (tingle in hands and feet), ANOSMIA (could not smell or taste), AGEUSIA (could not smell or taste), HYPOAESTHESIA ORAL (tip of tongue was numb) and HEADACHE (Headache/Head hurt all over) had not resolved and EAR CONGESTION (congestion in head, ear, feels like sinus infection), SINUSITIS (feels like sinus infection), HYPOACUSIS (cant hear very well, Feels virus in nervus.) and NASAL CONGESTION (congestion in head, ear, feels like sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other treatment medications include steroid treatment and albuterol. Patient stated that Tylenol and Robitussin did not help and took albuterol.  Patient received second dose of vaccine on 26MAR2021 in the left arm. Patient also stated that this caused a 4-day delay in the second dose due to steroid treatment.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.