Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, General physical health deterioration, Illness, Influenza
Clinical narrative: general malaise; aching from head to toe; very sick; fever/if he does not take advil/tylenol he runs a fever; he is not good/16 minutes after the shot he was very sick / he is not well; He's been declining since he had the shot/he cannot work; his breathing is horrible/cannot catch a breath/if he does not use his inhaler, he cannot breath; diagnosed with the flu; diagnosed with infection in his lungs/possibility of a pneumonia; This spontaneous case was reported by an other health care professional and describes the occurrence of PNEUMONIA (diagnosed with infection in his lungs/possibility of a pneumonia) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 031L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE (BREZTRI AEROSPHERE) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced VACCINATION COMPLICATION (he is not good/16 minutes after the shot he was very sick / he is not well), GENERAL PHYSICAL HEALTH DETERIORATION (He's been declining since he had the shot/he cannot work) and DYSPNOEA (his breathing is horrible/cannot catch a breath/if he does not use his inhaler, he cannot breath). On 10-Oct-2021, the patient experienced PYREXIA (fever/if he does not take advil/tylenol he runs a fever). In October 2021, the patient experienced PNEUMONIA (diagnosed with infection in his lungs/possibility of a pneumonia) (seriousness criterion medically significant) and INFLUENZA (diagnosed with the flu). On an unknown date, the patient experienced MALAISE (general malaise), PAIN (aching from head to toe) and ILLNESS (very sick). The patient was treated with ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and AZITHROMYCIN (ZITHROMAX) for Adverse event, at a dose of 500 mg four times per week. At the time of the report, PNEUMONIA (diagnosed with infection in his lungs/possibility of a pneumonia), VACCINATION COMPLICATION (he is not good/16 minutes after the shot he was very sick / he is not well), GENERAL PHYSICAL HEALTH DETERIORATION (He's been declining since he had the shot/he cannot work), DYSPNOEA (his breathing is horrible/cannot catch a breath/if he does not use his inhaler, he cannot breath), MALAISE (general malaise), INFLUENZA (diagnosed with the flu), PAIN (aching from head to toe), ILLNESS (very sick) and PYREXIA (fever/if he does not take advil/tylenol he runs a fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Oct-2021, Body temperature: high (High) high. On an unknown date, X-ray: abnormal (abnormal) that there was the possibility of a pneumonia.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On unknown date, the patient had an additional test performed that included a nostril (strip test), however, the result was that he had the flu and an infection in his lungs provided. Patient was dentist and they had to cancel his agenda for today because patient cannot work.  If he did not take advil/tylenol he experience a fever. On 10 Oct 2021, Patient went to the hospital.  Company comment: This case concerns a 70-year-old, male patient with medical history of chronic obstructive pulmonary disease, who experienced the unexpected serious event of pneumonia with other non-serious unexpected and expected adverse events. The event of pneumonia occurred on october, a few days after the third dose of Spikevax (Moderna COVID-19 vaccine; exact date unknown). The rechallenge was not applicable since the event occurred after the third dose of vaccine. The medical history of chronic obstructive pulmonary disease remain a confounder as could be a risk factor for pneumonia. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-348854, MOD-2021-348894 (Patient Link).; Sender's Comments: This case concerns a 70-year-old, male patient with medical history of chronic obstructive pulmonary disease, who experienced the unexpected serious event of pneumonia with other non-serious unexpected and expected adverse events. The event of pneumonia occurred on october, a few days after the third dose of Spikevax (Moderna COVID-19 vaccine; exact date unknown). The rechallenge was not applicable since the event occurred after the third dose of vaccine. The medical history of chronic obstructive pulmonary disease remain a confounder as could be a risk factor for pneumonia. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.