Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Syncope
Clinical narrative: not breathing; Dizziness; nausea; fainted; unconscious; not breathing; Flu like symptoms/ Fever/ joint pain/Her joint pain was excruciating on Friday evening in her hips, and both shoulder joints/ swelling over her body; low blood pressure; This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (fainted), LOSS OF CONSCIOUSNESS (unconscious) and APNOEA (not breathing) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products GABAPENTIN for an unknown indication, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) for an unknown indication and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine. Concurrent medical conditions included Mast cell activation syndrome, Food allergy (Severe allergic to corn and corn products.), Pollen allergy and Allergy to chemicals.   On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient started GABAPENTIN (unknown route) 600 milligram, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) (unknown route) 600 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (unknown route) 1 dosage form. On 15-Dec-2022, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (unconscious) (seriousness criterion medically significant), APNOEA (not breathing) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms/ Fever/ joint pain/Her joint pain was excruciating on Friday evening in her hips, and both shoulder joints/ swelling over her body), HYPOTENSION (low blood pressure), DIZZINESS (Dizziness) and NAUSEA (nausea). On an unknown date, the patient experienced DYSPNOEA (not breathing). At the time of the report, SYNCOPE (fainted), LOSS OF CONSCIOUSNESS (unconscious), APNOEA (not breathing), INFLUENZA LIKE ILLNESS (Flu like symptoms/ Fever/ joint pain/Her joint pain was excruciating on Friday evening in her hips, and both shoulder joints/ swelling over her body), HYPOTENSION (low blood pressure), DIZZINESS (Dizziness) and NAUSEA (nausea) had not resolved and DYSPNOEA (not breathing) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Company Comment This spontaneous case concerns a 71-years-old female patient, with medical history of Mast cell activation syndrome, food, chemical, and pollen allergy, severely allergic to Corn and all corn products. previously administered Moderna COVID-19 Vaccine, without adverse events, co-suspect products GABAPENTIN; TYLENOL WITH CODEINE and DIPHENHYDRAMINE  who experienced the unexpected seriousness criterion medically significant events of  syncope, loss of consciousness and apnoea; the unexpected events of influenza like illness, hypotension, dyspnoea and other expected events beginning the same day after a dose of mRNA- 1273 bivalent vaccine. The medical history of Mast cell activation syndrome is a confounder for the event nausea; the co-suspect medication of GABAPENTIN is a contributor for influenza like illness of pyrexia, the events dizziness, apnoea, dispnoea and nausea; TYLENOL WITH CODEINE for the events hypotension, influenza like illness symptom sweating, events nausea, dizziness, dyspnoea and apnoea. The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: Company Comment This spontaneous case concerns a 71-years-old female patient, with medical history of Mast cell activation syndrome, food, chemical, and pollen allergy, severely allergic to Corn and all corn products. previously administered Moderna COVID-19 Vaccine, without adverse events, co-suspect products GABAPENTIN; TYLENOL WITH CODEINE and DIPHENHYDRAMINE  who experienced the unexpected seriousness criterion medically significant events of  syncope, loss of consciousness and apnoea; the unexpected events of influenza like illness, hypotension, dyspnoea and other expected events beginning the same day after a  dose of  mRNA- 1273 bivalent vaccine. The medical history of Mast cell activation syndrome is a confounder for the event nausea; the co-suspect medication of GABAPENTIN is a contributor for influenza like illness of pyrexia, the events dizziness, apnoea, dispnoea and nausea; TYLENOL WITH CODEINE for the events hypotension, influenza like illness symptom sweating, events nausea, dizziness, dyspnoea and apnoea. The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.