Reporte zur Charge LOT 041B21A

Symptomtext

tingling down back and arms; felt he was getting very hot; itching down back of his head into his arms; Anaphylaxis; blurry vision; difficulty swallowing; pain in throat; upset stomach; very shaky; felt like something was stuck in his throat/complained he still had globus; This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LOT 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sulfonamide allergy (history of allergy to sulfa) and Drug allergy (flu vaccine). On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant), VISION BLURRED (blurry vision), DYSPHAGIA (difficulty swallowing), OROPHARYNGEAL PAIN (pain in throat), ABDOMINAL DISCOMFORT (upset stomach), NERVOUSNESS (very shaky) and SENSATION OF FOREIGN BODY (felt like something was stuck in his throat/complained he still had globus). On an unknown date, the patient experienced PARAESTHESIA (tingling down back and arms), FEELING HOT (felt he was getting very hot) and PRURITUS (itching down back of his head into his arms). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis), VISION BLURRED (blurry vision), DYSPHAGIA (difficulty swallowing), OROPHARYNGEAL PAIN (pain in throat), ABDOMINAL DISCOMFORT (upset stomach), NERVOUSNESS (very shaky), SENSATION OF FOREIGN BODY (felt like something was stuck in his throat/complained he still had globus), PARAESTHESIA (tingling down back and arms), FEELING HOT (felt he was getting very hot) and PRURITUS (itching down back of his head into his arms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Blood pressure measurement: 150/70 BP at 14:32 180/90 BP at 14:35 172/94 BP at 14:38. On 07-Apr-2021, Heart rate: 74 (normal) normal. On 07-Apr-2021, Oxygen saturation: 98 %. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information provided included 0.3mg Epi given to right thigh at 14:32. The patient complained he still had globus, still had blurry vision, itchiness and was feeling even hotter. The patient's blood pressure reported was 180/90 at 1435. The patient reported "hammer to his head" headache at 14:37 and continued blurry vision and globus. At 14:38, the patient's blood pressure reported was 172/94. Epi 0.3mg was given to left thigh at 14:38. At 14:40 the patient was getting very shaky and was given to ambulance services. Company comment Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Anaphylaxis is consistent with the product known safety profile.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Anaphylaxis is consistent with the product known safety profile.