Sex: M
Vaccine: COVID19
Symptoms: Fall, Fatigue, Loss of consciousness, Pain in extremity
Clinical narrative: pass out/passed out after receiving a moderna vaccine; patient fell down from his chair; arm soreness at the injection site; some fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (pass out/passed out after receiving a moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 054A22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dizzy (the week before patient went to get his shot), Panic attacks (with needles, vaccinations and shots) since an unknown date, Fear of needles since an unknown date and Broken ankle (when he was 14 when given his required school immunizations in the past because of his anxiety, he was held down during the vaccine and he jerked so hard he broke his own ankle.). Concurrent medical conditions included Chiari malformation.    On 27-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In May 2022, the patient experienced PAIN IN EXTREMITY (arm soreness at the injection site) and FATIGUE (some fatigue). On 27-May-2022, the patient experienced LOSS OF CONSCIOUSNESS (pass out/passed out after receiving a moderna vaccine) (seriousness criterion medically significant) and FALL (patient fell down from his chair). On 27-May-2022, LOSS OF CONSCIOUSNESS (pass out/passed out after receiving a moderna vaccine) had resolved. At the time of the report, FALL (patient fell down from his chair) had resolved and PAIN IN EXTREMITY (arm soreness at the injection site) and FATIGUE (some fatigue) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient has no allergies.  No concomitant product was provided. No treatment information was provided.  Patient was informed that he would need to see a doctor or nurse if he wishes to receive any vaccinations in the future since he has Chiari and severe anxiety with needles.  Company Comment: This spontaneous case concerns a male patient, of unknown age, with relevant history of panic attacks with needles, vaccinations and shots, who experienced the unexpected, serious (medically significant) event of loss of consciousness and other associated non-serious events. The event loss of consciousness and the non-serious event fall occurred on the same day after receiving the first dose of the mRNA-1273 vaccine. The start dates of the other events were not provided. It was reported that the patient passed out after vaccination. The reporter called emergency and the paramedics took care of the patient. The patient was breathing fine, however, he fell down from his chair. The patient was not brought to the hospital as the paramedics were able to treat him. However, treatment information was not provided. After the patient regained consciousness, he said that he has panic attacks with needles, vaccinations and shots, and that he felt dizzy the week before he got vaccinated. The following day, the reporter followed up with the patient. He was doing well and had no dizziness, however, he had some arm soreness at the injection site and some fatigue. The history of panic attacks with needles, vaccinations and shots remains a confounder for the event loss of consciousness. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-580161 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2022: Follow-up received included updated patient initials, batch number and expiration date.; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with relevant history of panic attacks with needles, vaccinations and shots, who experienced the unexpected, serious (medically significant) event of loss of consciousness and other associated non-serious events. The event loss of consciousness and the non-serious event fall occurred on the same day after receiving the first dose of the mRNA-1273 vaccine. The start dates of the other events were not provided. It was reported that the patient passed out after vaccination. The reporter called emergency and the paramedics took care of the patient. The patient was breathing fine, however, he fell down from his chair. The patient was not brought to the hospital as the paramedics were able to treat him. However, treatment information was not provided. After the patient regained consciousness, he said that he has panic attacks with needles, vaccinations and shots, and that he felt dizzy the week before he got vaccinated. The following day, the reporter followed up with the patient. He was doing well and had no dizziness, however, he had some arm soreness at the injection site and some fatigue. The history of panic attacks with needles, vaccinations and shots remains a confounder for the event loss of consciousness. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.