Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Magnetic resonance imaging head, Peripheral swelling, Product administration interrupted, Pruritus
Clinical narrative: She cannot have the second moderna Covid 19 vaccine and recommending getting the pfizer covid 19 vaccine; product administration interrupted; Brain hemorrhage; Allergic reaction/ allergic reaction to tromethamine; Face, eyes, ears, lips and hands were swollen; Face, eyes, ears, lips and hands were swollen; Face, eyes, ears, lips and hands were swollen; Face, eyes, ears, lips and hands were swollen; swelling in her hands; Hands were itching; redness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMORRHAGE (Brain hemorrhage) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product GADOBUTROL (GADAVIST) for MRI brain.    The patient's past medical history included No adverse event (No medical history reported). Concomitant products included DILTIAZEM, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) and HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started GADOBUTROL (GADAVIST) (unknown route) at an unspecified dose. On 18-Jan-2021, the patient experienced CEREBRAL HAEMORRHAGE (Brain hemorrhage) (seriousness criterion medically significant), DRUG HYPERSENSITIVITY (Allergic reaction/ allergic reaction to tromethamine), SWELLING FACE (Face, eyes, ears, lips and hands were swollen), EYE SWELLING (Face, eyes, ears, lips and hands were swollen), EAR SWELLING (Face, eyes, ears, lips and hands were swollen), LIP SWELLING (Face, eyes, ears, lips and hands were swollen), PERIPHERAL SWELLING (swelling in her hands), PRURITUS (Hands were itching) and ERYTHEMA (redness). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (She cannot have the second moderna Covid 19 vaccine and recommending getting the pfizer covid 19 vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (product administration interrupted). On 20-Jan-2021, DRUG HYPERSENSITIVITY (Allergic reaction/ allergic reaction to tromethamine), SWELLING FACE (Face, eyes, ears, lips and hands were swollen), EYE SWELLING (Face, eyes, ears, lips and hands were swollen), EAR SWELLING (Face, eyes, ears, lips and hands were swollen), LIP SWELLING (Face, eyes, ears, lips and hands were swollen), PERIPHERAL SWELLING (swelling in her hands) and PRURITUS (Hands were itching) had resolved. At the time of the report, CEREBRAL HAEMORRHAGE (Brain hemorrhage) and ERYTHEMA (redness) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (She cannot have the second moderna Covid 19 vaccine and recommending getting the pfizer covid 19 vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (product administration interrupted) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Magnetic resonance imaging brain: unknown (Inconclusive) With contrast Gadavist..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Both Moderna COVID-19 vaccine and Gadavist had tromethamine and ended up in the emergency room. The patient was taken to the emergency room (ER) and treated with intravenous diphenhydramine and steroids. It was stated that the swelling lasted 36 hours and the patient was prescribed prednisone to treat symptoms after leaving ER. The patient was not admitted to the hospital.  The patient was told by her Internist she cannot have the second Moderna COVID-19 vaccine and is recommending getting the Pfizer COVID-19 vaccine for her second dose. Patient received the treatment which is unspecified.  Very limited information regarding this event has been provided at this time. This report refers to a case of interchange of vaccine products for mRNA-1273 (lot # unknown), with no associated AEs. Further information has been requested. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Updated patient details, medical history, suspect product details, added new suspect product, events updated. Hospitalization was unchecked for drug hypersensitivity and cerebral hemorrhage. Interchange of vaccine products was added as event.; Sender's Comments: Very limited information regarding this event has been provided at this time. This report refers to a case of interchange of vaccine products for mRNA-1273 (lot # unknown), with no associated AEs. Further information has been requested. Further information has been requested.