Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Bone tuberculosis, Delirium, Dizziness, Dysarthria
Clinical narrative: peeing all over the place/Constantly had go to the bathroom 30 times; Feels like she's going to pass out.; Couldn't walk; had to use a walker.; Jaw pain on the right side; She was slurring words; Teeth were hurting; head feels like it is splitting in two; POTTS 12 hours after receiving the Moderna COVID-19 booster; Delirious; This spontaneous case was reported by an other health care professional and describes the occurrence of BONE TUBERCULOSIS (POTTS 12 hours after receiving the Moderna COVID-19 booster) and DELIRIUM (Delirious) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 011A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy and Asthma (1 puff for asthma). Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Allergy, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, ATORVASTATIN for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021 at 12:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant). On 02-Nov-2021 at 1:00 AM, the patient experienced BONE TUBERCULOSIS (POTTS 12 hours after receiving the Moderna COVID-19 booster) (seriousness criterion medically significant), POLYURIA (peeing all over the place/Constantly had go to the bathroom 30 times), DIZZINESS (Feels like she's going to pass out.), GAIT INABILITY (Couldn't walk; had to use a walker.), PAIN IN JAW (Jaw pain on the right side), DYSARTHRIA (She was slurring words), TOOTHACHE (Teeth were hurting) and HEADACHE (head feels like it is splitting in two). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 02-Nov-2021 for Headache, at a dose of 2 dosage form. At the time of the report, BONE TUBERCULOSIS (POTTS 12 hours after receiving the Moderna COVID-19 booster), DELIRIUM (Delirious), POLYURIA (peeing all over the place/Constantly had go to the bathroom 30 times), DIZZINESS (Feels like she's going to pass out.), GAIT INABILITY (Couldn't walk; had to use a walker.), PAIN IN JAW (Jaw pain on the right side), DYSARTHRIA (She was slurring words), TOOTHACHE (Teeth were hurting) and HEADACHE (head feels like it is splitting in two) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, Blood pressure measurement (82-120): 160/110 (High) Blood pressure was 160/110. On 02-Nov-2021, Heart rate: 140 (High) Pulse was fast 140 bpm.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had to use a walker. Drank a lot of water and took 2 Tylenol this morning because head feels like it's splitting in two. Starting to feel better now. Patient was able to walk a little bit now.  Company comment: This case concerns a 72-year-old, female patient, with no relevant medical history, who experienced the serious, unexpected events of bone tuberculosis and delirium. The events occurred  12 hrs after third dose of Moderna vaccine. The rechallenge is not applicable as events occurred after booster dose and no additional doses expected. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-038366 (Patient Link).; Sender's Comments: This case concerns a 72-year-old, female patient, with no relevant medical history, who experienced the serious, unexpected events of bone tuberculosis and delirium. The events occurred  12 hrs after third dose of Moderna vaccine. The rechallenge is not applicable as events occurred after booster dose and no additional doses expected. The benefit-risk relationship of Moderna vaccine is not affected by this report.