Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site swelling, Vasculitis
Clinical narrative: sick one day; felt a strange feeling in their legs and knee\knees gave out; hit their head\two brain hemorrhages\brain bleeds; vasculitis and it was very scary/ still tired; immune system is compromised; a cut on her lip from the fall; covid arm; can't go to bed at night; felt like they had Covid; swelling 2 inches or more from  elbow; Revaccination with different COVID-19 vaccine; interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick one day), LIMB DISCOMFORT (felt a strange feeling in their legs and knee\knees gave out), CEREBRAL HAEMORRHAGE (hit their head\two brain hemorrhages\brain bleeds), VASCULITIS (vasculitis and it was very scary/ still tired) and IMMUNODEFICIENCY (immune system is compromised) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028K21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Inflammation, Accident automobile in 1997, Headache, Fever, Sickness and Feeling bad. Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE on 15-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Migraine and Walker user. Concomitant products included SERTRALINE for Anxiety, PHENYTOIN (DILANTIN [PHENYTOIN]), CALCIUM and MAGNESIUM for an unknown indication.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick one day) (seriousness criterion hospitalization), LIMB DISCOMFORT (felt a strange feeling in their legs and knee\knees gave out) (seriousness criterion hospitalization), CEREBRAL HAEMORRHAGE (hit their head\two brain hemorrhages\brain bleeds) (seriousness criteria hospitalization and medically significant), VASCULITIS (vasculitis and it was very scary/ still tired) (seriousness criterion hospitalization), IMMUNODEFICIENCY (immune system is compromised) (seriousness criterion medically significant), FALL (a cut on her lip from the fall), VACCINATION SITE REACTION (covid arm), INSOMNIA (can't go to bed at night), SUSPECTED COVID-19 (felt like they had Covid), VACCINATION SITE SWELLING (swelling 2 inches or more from  elbow), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, ILLNESS (sick one day), LIMB DISCOMFORT (felt a strange feeling in their legs and knee\knees gave out), CEREBRAL HAEMORRHAGE (hit their head\two brain hemorrhages\brain bleeds), VASCULITIS (vasculitis and it was very scary/ still tired), IMMUNODEFICIENCY (immune system is compromised), FALL (a cut on her lip from the fall), VACCINATION SITE REACTION (covid arm), INSOMNIA (can't go to bed at night), SUSPECTED COVID-19 (felt like they had Covid), VACCINATION SITE SWELLING (swelling 2 inches or more from  elbow), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram head: two brain hemorrhages, brain bleeds.         No treatment medications were provided.  Patient got Pfizer booster last October. Patient felt really well.migraine medication did not take care of it, Patient stomach began to feel funny and that was the first time. When they talked to their doctor about their reaction, they suggested they get Moderna or the 4th shot. Patient was sick one day and also felt a strange feeling in their legs and knee and could not get up. Patient transported to the trauma center where there was no care and they spent two days in the emergency room hall with a mask on. Patient got the Pfizer vaccine in the beginning, and they got an immunity shot before the vaccine and they got sick.Patient had previous brain injury from an auto accident.  Patient felt the boosters were stronger than the first two shots. Patient said there were a lot of symptoms and they contacted Pfizer already about the reaction. Patient did not eat sugar. patient went to the hospital the second week in May.Patient was taking Migraine medication.   Reporter did not allow further contact.  Company comment: This is a spontaneous case concerns a 76-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant and hospitalization) AESI of Cerebral haemorrhage, unexpected serious (hospitalization) events of Illness, Limb discomfort, Vasculitis, unexpected serious (medically significant) Immunodeficiency, unexpected non-serious AESI of Suspected COVID-19 and non-serious event of Fall which occurred on an unknown date after the fourth dose of mRNA-1273 vaccine in covid-19 vaccination series. Approximately few weeks after the 2nd booster with mRNA-1273, patient had a fall as she had knee buckling, she might have hit her head and as she could not get up, she called emergency services. At the hospital Cat scan showed two brain hemorrhages and brain bleeds, which were resolved at the time of consultation and gave an outline of vasculitis. COVID-19 immunisation and Interchange of vaccine products is also noted in this case as the patient received three doses of Pfizer approximately 6 months prior to current mRNA-1273 vaccine. Patients elderly age could be risk factor for the event Vasculitis. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerns a 76-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant and hospitalization) AESI of Cerebral haemorrhage, unexpected serious (hospitalization) events of Illness, Limb discomfort, Vasculitis, unexpected serious (medically significant) Immunodeficiency, unexpected non-serious AESI of Suspected COVID-19 and non-serious event of Fall which occurred on an unknown date after the fourth dose of mRNA-1273 vaccine in covid-19 vaccination series. Approximately few weeks after the 2nd booster with mRNA-1273, patient had a fall as she had knee buckling, she might have hit her head and as she could not get up, she called emergency services. At the hospital Cat scan showed two brain hemorrhages and brain bleeds, which were resolved at the time of consultation and gave an outline of vasculitis. COVID-19 immunisation and Interchange of vaccine products is also noted in this case as the patient received three doses of Pfizer approximately 6 months prior to current mRNA-1273 vaccine. Patients elderly age could be risk factor for the event Vasculitis. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.