Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness
Clinical narrative: knocked me off my feet and I could not get out of bed for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (knocked me off my feet and I could not get out of bed for 24 hours) in a 64-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Welts (Twenty-five or thirty years ago she had a TB test with ppd. After that test, her entire arm blewed up instantly with a giant welt). Previously administered products included for Drug use for unknown indication: Flu shots (patient received vaccine so many years back without any events other than sore arm.), TD and Typhoid. Past adverse reactions to the above products included No adverse event with TD and Typhoid; and Tenderness with Flu shots.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (knocked me off my feet and I could not get out of bed for 24 hours) (seriousness criterion medically significant). At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (knocked me off my feet and I could not get out of bed for 24 hours) outcome was unknown.            On the unknown date patient developed a serious kind of knocked me out a little bit following the administration of influenza quadrival a-b high dose hv.  It was reported that she has taken pneumonia vaccine without problems. Twenty-five or thirty years ago she had a TB test with ppd. She was told at first that she had T B. A follow-up chest x-ray was negative. It was realized that she did not have TB and that instead something was wrong with that test. She later had subsequent ppd tests without reactions. She suspected that test was contaminated with something.   Concomitant medications were not reported.  It was reported that when she received the second full dose of the initial series of Moderna Covid vaccine, that dose knocked her off patient feet and she could not get out of bed for 24 hours.  Treatment medications were not reported  Company comment: This spontaneous case concerns a 64-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Depressed level of consciousness (reported as knocked me off my feet and I could not get out of bed for 24 hrs) that occurred on unspecified day in context to the second dose of mRNA-1273 vaccine in the Covid-19 vaccination series. No further information regarding risk factors, medical history, concurrent condition, clinical course, investigations and treatment received were reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-679491 (Linked Report). This case was linked to MOD-2022-679491 (Patient Link).; Sender's Comments: This spontaneous case concerns a 64-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Depressed level of consciousness (reported as knocked me off my feet and I could not get out of bed for 24 hrs) that occurred on unspecified day in context to the second dose of mRNA-1273 vaccine in the Covid-19 vaccination series. No further information regarding risk factors, medical history, concurrent condition, clinical course, investigations and treatment received were reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-679491:Second dose