Sex: F
Vaccine: COVID19
Symptoms: Headache, Pneumonia
Clinical narrative: This spontaneous case was reported by a consumer 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. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis. Concurrent medical conditions included Psoriatic arthritis. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and HEADACHE (second and booster vaccine caused a headache). At the time of the report, PNEUMONIA (Pneumonia) had not resolved and HEADACHE (second and booster vaccine caused a headache) had resolved. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Concomitant Medication use information was not provided by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The daily dose of Moderna COVID-19 Vaccine was given as (1 in 1 Once). Treatment Medication use information was not provided by reporter. Company comment: This spontaneous case concerns a 64 year old female patient with concurrent condition of psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Pneumonia, unknown days after receiving the booster dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also received the first and second doses of the same vaccine on unknown dates, with reported event of headache after the second dose. No information on exact date of the event and vaccination schedule, detailed clinical course, relevant investigations and treatment of the event was available in the report. The event was not resolved. Concomitant adalimumab could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Non-Significant Live Follow Up Appended contains no new information.; Sender's Comments: This spontaneous case concerns a 64 year old female patient with concurrent condition of psoriatic arthritis, who experienced the unexpected serious (medically significant) event of Pneumonia, unknown days after receiving the booster dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient also received the first and second doses of the same vaccine on unknown dates, with reported event of headache after the second dose. No information on exact date of the event and vaccination schedule, detailed clinical course, relevant investigations and treatment of the event was available in the report. The event was not resolved. Concomitant adalimumab could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.