Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Restlessness, Vaccination site pain
Clinical narrative: He couldn't move from the bedroom to the living room; when he feels it coming he can feel his muscles weak/He had extreme muscle weakness/and is still having extreme muscle weakness; restless; Had no energy/some times he doesn't have energy; It just hurts to walk/It just hurts to move; He statesthat when he got the second vaccine he got a sinus infection that was not presenting yet/he had a existing infection in his body; His arm started to hurt about a month afterwards; Maybe 3 weeks afterwards, it was sore to the bone/This is the whole other thing, the other side effect: He just had soreness down to his bones/ It almost feels like shoulder is dislocated; Was completely knocked out/but yesterday he was just completely knocked out; was tired/exhausted/Felt completely exhausted; High fever/Over the weekend he had off and on high fever; He came home and had tons of energy; Later on that evening he started with body aches; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was completely knocked out/but yesterday he was just completely knocked out) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (NOS) (Cancer survivor). Concurrent medical conditions included Asthma, Hypertension, Migraine and Hypokalemic periodic paralysis. Concomitant products included BECLOMETASONE DIPROPIONATE (QVAR) for Asthma, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY XR) for Diabetes, METOPROLOL TARTRATE for Heart disorder, LOSARTAN for Hypertension, ZOPICLONE for Insomnia NOS, ROSUVASTATIN CALCIUM (CRESTOR) for Lipids, ALPRAZOLAM, TADALAFIL (CIALIS), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR), DULAGLUTIDE (TRULICITY), OMEPRAZOLE, FINASTERIDE and VITAMINS NOS for an unknown indication.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ENERGY INCREASED (He came home and had tons of energy), MYALGIA (Later on that evening he started with body aches) and PYREXIA (High fever/Over the weekend he had off and on high fever). On 26-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Was completely knocked out/but yesterday he was just completely knocked out) (seriousness criterion medically significant) and FATIGUE (was tired/exhausted/Felt completely exhausted). In May 2021, the patient experienced BONE PAIN (Maybe 3 weeks afterwards, it was sore to the bone/This is the whole other thing, the other side effect: He just had soreness down to his bones/ It almost feels like shoulder is dislocated) and VACCINATION SITE PAIN (His arm started to hurt about a month afterwards). On an unknown date, the patient experienced MOBILITY DECREASED (He couldn't move from the bedroom to the living room), MUSCULAR WEAKNESS (when he feels it coming he can feel his muscles weak/He had extreme muscle weakness/and is still having extreme muscle weakness), RESTLESSNESS (restless), ASTHENIA (Had no energy/some times he doesn't have energy), GAIT DISTURBANCE (It just hurts to walk/It just hurts to move) and INFECTION (He statesthat when he got the second vaccine he got a sinus infection that was not presenting yet/he had a existing infection in his body). The patient was treated with AZITHROMYCIN on 22-Apr-2021 for Sinus infection, at a dose of twice was a Z pack and DOXYCYCLINE on 22-Apr-2021 for Sinus infection, at a dose of Twice. At the time of the report, LOSS OF CONSCIOUSNESS (Was completely knocked out/but yesterday he was just completely knocked out), ENERGY INCREASED (He came home and had tons of energy), MOBILITY DECREASED (He couldn't move from the bedroom to the living room), MUSCULAR WEAKNESS (when he feels it coming he can feel his muscles weak/He had extreme muscle weakness/and is still having extreme muscle weakness), RESTLESSNESS (restless), ASTHENIA (Had no energy/some times he doesn't have energy), BONE PAIN (Maybe 3 weeks afterwards, it was sore to the bone/This is the whole other thing, the other side effect: He just had soreness down to his bones/ It almost feels like shoulder is dislocated), GAIT DISTURBANCE (It just hurts to walk/It just hurts to move), INFECTION (He statesthat when he got the second vaccine he got a sinus infection that was not presenting yet/he had a existing infection in his body), VACCINATION SITE PAIN (His arm started to hurt about a month afterwards), MYALGIA (Later on that evening he started with body aches), FATIGUE (was tired/exhausted/Felt completely exhausted) and PYREXIA (High fever/Over the weekend he had off and on high fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient states that he can't take certain medications like azithromycin and prednisone as they might trigger hypokalemic periodic paralysis which is a condition that causes extreme muscle weakness, he probably had it since a kid, sometimes they call it dead sleep, but this also happened to caller after he had the shot.  Lab data: Patients states he had every test done, they performed blood work on him, to check if it was lyme disease or some other disease.  Treatment includes: When patient feels his muscles weak he used to take liquid potassium and liquid magnesium mixed with juice and then felt better and then takes it again after an hour. For his arm, He has been using ice, vial freeze on it. He has had at least 4 doses of antibiotics (twice was a Z pack of azithromycin, and then twice Doxycycline ) since 22April2021. Patient did not receive treatment for his symptoms  This case concerns a 62-year-old male patient who with past medical history of cancer (Nos) and concurrent history of  asthma, hypertension, Migraine and hypokalemic periodic paralysis, who experienced unexpected event of loss of consciousness.  The event occurred 4 days after administration of the second dose of the mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as no details about the first dose was not disclosed. Causality for the event with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events assessed as medically significant per regulatory authority reporting.   This case was linked to MOD-2021-356348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow-up received and contains no new information; Sender's Comments: This case concerns a 62-year-old male patient who with past medical history of cancer (Nos) and concurrent history of  asthma, hypertension, Migraine and hypokalemic periodic paralysis, who experienced unexpected event of loss of consciousness.  The event occurred 4 days after administration of the second dose of the mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as no details about the first dose was not disclosed. Causality for the event with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events assessed as medically significant per regulatory authority reporting.