Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 immunisation, Dyspnoea, Interchange of vaccine products, Loss of consciousness
Clinical narrative: Interchange of vaccine products; revaccination with different COVID-19 vaccine; Black out; breathless; get my best back in my energy back; I don't remember things; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Black out) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient not tested for covid-19 and never had symptoms for COVID.  The patient's past medical history included Near death experience (she really was dying in 2016 and had to be hospitalized for a month) in 2016 and Lyme disease in 2015. Previously administered products included for Product used for unknown indication: Flu shot (she really was dying in 2016 and had to be hospitalized for a month) in 2016 and J and J (1st dose  lot #1805025) on 13-Mar-2021. Past adverse reactions to the above products included Adverse reaction with Flu shot; and No adverse event with J and J. Concurrent medical conditions included Asthma, Pollen allergy, Allergy to molds, Antiphospholipid syndrome in 2016 and Walker user (had to use back in 2016 when she first came down with autoimmune issues) in 2016.    On 15-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Nov-2022, the patient experienced DYSPNOEA (breathless). In November 2022, the patient experienced ASTHENIA (get my best back in my energy back) and MEMORY IMPAIRMENT (I don't remember things). On 16-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced LOSS OF CONSCIOUSNESS (Black out) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different COVID-19 vaccine). At the time of the report, LOSS OF CONSCIOUSNESS (Black out) had resolved, DYSPNOEA (breathless), ASTHENIA (get my best back in my energy back) and MEMORY IMPAIRMENT (I don't remember things) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different COVID-19 vaccine) outcome was unknown.            Concomitant medication was not provided. Patient had blackout, hit her head and been unconscious for a long time. Patient sprained her ankle, twisted her neck, she busted open her lip, bruised her jaw, chest was in some amount of pain, injury that prevents her from walking now/hard for her to walk. Since receiving the shot patient no longer good causing the stroke and Physical impairment. Treatment medication information was not provided by the reporter.  Company Comment: This spontaneous case concerns a 75 year old female patient, with a relevant history of antiphospholipid syndrome, who experienced the unexpected serious (medically significant) event Loss of consciousness, along with non-serious events dyspnoea, asthenia and memory impairment,  which occurred 1 day after receiving a dose of mRNA-1273  BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) vaccine, given as the third booster dose. Patient was previously vaccinated with a dose of Janssen COVID-19 vaccine (Interchange of vaccine products, revaccination with different COVID-19 vaccine). The outcome for Loss of consciousness was reported as resolved. Patient reported sprained ankle, Lip injury, Contusion, Chest pain, inability to walk as result of the blackout.  Diagnostic workup or treatment information were not reported. Underlying history of antiphospholipid syndrome could be a confounder for the event Loss of consciousness. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-674779, MOD-2022-674732 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2022: Non-significant follow up ID added.; Reporter's Comments: Batch number of third moderna booster was reported as lot #015h22a or 016h22a and it was hard to distinguish for the patient which was correct one. Patient was sure that her body won't take the Moderna anymore. And it's Paradoxical to her because she has gotten healthier and healthier over the years. In terms of her auto immune disorders. She thought she had been getting healthier and she was hoping to getting rid of some of them. She had a lot of blood left done on Monday, Incidentally, and she will find out in a week or so a preliminary look at what my blood work is. On Monday before she had the vaccine the next day she felt fine. And maybe her blood work will come back. In a positive way, and that would be good. But since the shot she no longer Good. and she was hoping the only Lingering effect for her will be a sprained ankle that will eventually heal. She doesn't remember things. It came on instantaneously is what she was trying to say. the last thing she remembered in march was kneeling on the floor over her toilet vomiting dry heaving (and the last thing she remember on Wednesday she was trying to open cans of cat food at her kitchen counter. trying to feed her cats. and then she came on the floor. she don't know how long later she don't think as long as the last time because she still had blood. in her muscles, and she could still move them a little bit until  realized that she would either broken or sprained her ankle. Blackouts. Can be fatal. That's a sad Specially for old people. Her reaction could have been life threatening. She ended up in the hospital a year later and they never diagnosed properly; Sender's Comments: This spontaneous case concerns a 75 year old female patient, with a relevant history of antiphospholipid syndrome, who experienced the unexpected serious (medically significant) event Loss of consciousness, along with non-serious events dyspnoea, asthenia and memory impairment,  which occurred 1 day after receiving a dose of mRNA-1273  BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) vaccine, given as the third booster dose. Patient was previously vaccinated with a dose of Janssen COVID-19 vaccine (Interchange of vaccine products, revaccination with different COVID-19 vaccine). The outcome for Loss of conciousness was reported as resolved. Patient reported sprained ankle, Lip injury, Contusion, Chest pain, inability to walk as result of the blackout.  Diagnostic workup or treatment information were not reported. Underlying history of antiphospholipid syndrome could be a confounder for the event Loss of consciousness. The benefit-risk relationship of mRNA-1273 is not affected by this report.