Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, COVID-19, COVID-19 pneumonia, Condition aggravated, Insomnia
Clinical narrative: Condition aggravated; Sinus disorder; Taste changed; Asthma; Insomnia; Sunburn; Oxygen saturation low; COVID-19 WITH BI-LATERAL PNEUMONIA; COVID-19; Vaccination site pain; MODERNA COVID VACCINE WITH FIRST DOSE CAUSED SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 WITH BI-LATERAL PNEUMONIA) in a 54-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 Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and PAIN IN EXTREMITY (MODERNA COVID VACCINE WITH FIRST DOSE CAUSED SORE ARM). In December 2021, the patient experienced COVID-19 (COVID-19). On 29-Dec-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 WITH BI-LATERAL PNEUMONIA) (seriousness criterion medically significant). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated), SINUS DISORDER (Sinus disorder), TASTE DISORDER (Taste changed), ASTHMA (Asthma), INSOMNIA (Insomnia), SUNBURN (Sunburn) and OXYGEN SATURATION DECREASED (Oxygen saturation low). At the time of the report, COVID-19 PNEUMONIA (COVID-19 WITH BI-LATERAL PNEUMONIA), COVID-19 (COVID-19) and OXYGEN SATURATION DECREASED (Oxygen saturation low) had resolved, CONDITION AGGRAVATED (Condition aggravated), SINUS DISORDER (Sinus disorder), TASTE DISORDER (Taste changed), ASTHMA (Asthma) and INSOMNIA (Insomnia) had not resolved and SUNBURN (Sunburn), VACCINATION SITE PAIN (Vaccination site pain) and PAIN IN EXTREMITY (MODERNA COVID VACCINE WITH FIRST DOSE CAUSED SORE ARM) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. On 30 Jan 2022, the patient again experienced COVID-19. In 2022, COVID-19 got resolved. No treatment medications was reported.  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  Company comment. This spontaneous case concerns a 54  year  old female patient, in treatment with co  suspect product Adalimumab due to plaque psoriasis, who received 3 doses of mRNA-1273 vaccine with an appropriate interval between doses and experienced the non  serious unexpected AESI of COVID-19, the month after receiving the booster dose of mRNA-1273. The outcome of this event was unknown. One month, 27 days after the booster dose, the patient experienced the medically significant unexpected AESI of COVID  19 pneumonia (described as COVID  19 with bi  lateral pneumonia). Oxygen saturation low was reported with an unspecified onset date, and could be related with COVID  19 pneumonia, which had a recovered outcome. Approximately three months after vaccination, the patient reported COVID  19, also with recovered outcome, considered as non  serious, unexpected AESI. No further clinical information was available for medical reviewing. Patient´s concomitant medication Adalimumab remains as risk factor for infections (as COVID  19 and serious illness as COVID  19 pneumonia). The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Significant Follow Up received : Adverse events Sinus disorder, Oxygen saturation low, Taste changed, Insomnia, Asthma, Sunburn added, Lab data updated.The event of SORE ARM was amended to MODERNA COVID VACCINE WITH FIRST DOSE CAUSED SORE ARM. The event of COVID-19 AND PNEUMONIA was amended to COVID-19 WITH BI-LATERAL PNEUMONIA.; Sender's Comments: This spontaneous case concerns a 54  year  old female patient, in treatment with co  suspect product Adalimumab due to plaque psoriasis, who received 3 doses of mRNA-1273 vaccine with an appropriate interval between doses and experienced the non  serious unexpected AESI of COVID-19, the month after receiving the booster dose of mRNA-1273. The outcome of this event was unknown. One month, 27 days after the booster dose, the patient experienced the medically significant unexpected AESI of COVID  19 pneumonia (described as COVID  19 with bi  lateral pneumonia). Oxygen saturation low was reported with an unspecified onset date, and could be related with COVID  19 pneumonia, which had a recovered outcome. Approximately three months after vaccination, the patient reported COVID  19, also with recovered outcome, considered as non  serious, unexpected AESI. No further clinical information was available for medical reviewing. Patient´s concomitant medication Adalimumab remains as risk factor for infections (as COVID  19 and serious illness as COVID  19 pneumonia). The benefit-risk relationship of mRNA-1273 is not affected by this report.