Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pneumonia, Pyrexia, SARS-CoV-2 test, Skin laceration
Clinical narrative: Diagnosed with Pneumonia; Shortness of breath; Fever 100 F; Fell; Laceration on scalp after 1st dose/ staples on skull; Home health aids came to the house to help; Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Diagnosed with Pneumonia), DYSPNOEA (Shortness of breath), PYREXIA (Fever 100 F), FALL (Fell) and SKIN LACERATION (Laceration on scalp after 1st dose/ staples on skull) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by reporter.  Concomitant products included DILTIAZEM, FENOFIBRATE, LABETALOL, LEVOTHYROXINE, LISINOPRIL, METFORMIN, TORSEMIDE, TRAMADOL, WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), DOCUSATE SODIUM (COLACE), CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE (GLUCOSAMINE + CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]), MULTIVITAMIN [VITAMINS NOS], TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN (LUTEIN [TOCOPHERYL ACETATE;XANTOFYL;ZEAXANTHIN]), PROBIOTICS NOS, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), VITAMIN D [VITAMIN D NOS] and VITAMIN A [RETINOL] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Jan-2021, the patient experienced FALL (Fell) (seriousness criterion hospitalization), SKIN LACERATION (Laceration on scalp after 1st dose/ staples on skull) (seriousness criterion hospitalization) and DECREASED APPETITE (Loss of appetite). On 26-Jan-2021, the patient experienced PNEUMONIA (Diagnosed with Pneumonia) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization) and PYREXIA (Fever 100 F) (seriousness criterion hospitalization). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Home health aids came to the house to help). The patient was hospitalized on 26-Jan-2021 due to DYSPNOEA, FALL, PNEUMONIA, PYREXIA and SKIN LACERATION. The patient was treated with Surgery (Staples) for Skin laceration. At the time of the report, PNEUMONIA (Diagnosed with Pneumonia), DYSPNOEA (Shortness of breath), PYREXIA (Fever 100 F), FALL (Fell), SKIN LACERATION (Laceration on scalp after 1st dose/ staples on skull), DECREASED APPETITE (Loss of appetite) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Home health aids came to the house to help) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Computerised tomogram: normal (normal) Cat-Scan was clear, staples on skull and released. On 26-Jan-2021, Body temperature: 100 (High) Fever 100 F. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not provided. On16-JAN-2021, patient had felt and had laceration on scalp, called 911 and visited hospital. 10 days after first vaccination, patient went back to hospital to take staples off, while in the elevator at the hospital, patient had shortness of breath. Patient was taken back for examinations and was diagnosed with Pneumonia, and had a Fever 100F so they admitted her in the hospital  Company comment: This case concerns a 84-year-old female patient, with no reported relevant medical history, who experienced the unexpected serious events of PNEUMONIA, DYSPNOEA, PYREXIA, FALL and SKIN LACERATION. The events FALL and SKIN LACERATION occurred on the same day of the administration of the first dose of Moderna COVID-19 Vaccine. The events PNEUMONIA, DYSPNOEA and PYREXIA occurred 10 days after the administration of the first dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report   This case was linked to MOD-2021-369019 (Patient Link).; Sender's Comments: This case concerns a 84-year-old female patient, with no reported relevant medical history, who experienced the unexpected serious events of PNEUMONIA, DYSPNOEA, PYREXIA, FALL and SKIN LACERATION. The events FALL and SKIN LACERATION occurred on the same day of the administration of the first dose of Moderna COVID-19 Vaccine. The events PNEUMONIA, DYSPNOEA and PYREXIA occurred 10 days after the administration of the first dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report