Age: 63.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Lung infiltration
Clinical narrative: Still confused; Infiltrate in her lungs; Dehydration; Could not walk; Headache; Could not pee at all/could not urinate/hard time peeing/continues to have trouble urinating/Full bladder; This spontaneous case was reported by a patient and describes the occurrence of DYSURIA (Could not pee at all/could not urinate/hard time peeing/continues to have trouble urinating/Full bladder), CONFUSIONAL STATE (Still confused), LUNG INFILTRATION (Infiltrate in her lungs), DEHYDRATION (Dehydration), GAIT INABILITY (Could not walk) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F220A) for COVID-19 vaccination.     The patient was never tested positive or diagnosed with COVID-19. No other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included Stent placement (Three heart stents). Concurrent medical conditions included Allergy to antibiotic (Vancomycin), Penicillin allergy, Drug allergy (Aleve), Drug allergy (Dilantin) and Seizures. Concomitant products included LAMOTRIGINE (LAMICTAL), MIRTAZAPINE, QUETIAPINE, CLONAZEPAM (KLONOPIN), ASPIRIN [ACETYLSALICYLIC ACID], BACLOFEN, FUROSEMIDE (LASIX [FUROSEMIDE]), POTASSIUM CHLORIDE, ATORVASTATIN, PIROXICAM (PAXIL [PIROXICAM]), CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), ISOSORBIDE, TRAZODONE and TOPIRAMATE for an unknown indication.    On 11-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Nov-2022, the patient experienced CONFUSIONAL STATE (Still confused) (seriousness criterion hospitalization). In November 2022, the patient experienced DYSURIA (Could not pee at all/could not urinate/hard time peeing/continues to have trouble urinating/Full bladder) (seriousness criterion hospitalization), LUNG INFILTRATION (Infiltrate in her lungs) (seriousness criterion hospitalization), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), GAIT INABILITY (Could not walk) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). The patient was hospitalized from 15-Nov-2022 to 20-Nov-2022 due to CONFUSIONAL STATE, DEHYDRATION, DYSURIA, GAIT INABILITY, HEADACHE and LUNG INFILTRATION. At the time of the report, DYSURIA (Could not pee at all/could not urinate/hard time peeing/continues to have trouble urinating/Full bladder) was resolving, CONFUSIONAL STATE (Still confused) had not resolved and LUNG INFILTRATION (Infiltrate in her lungs), DEHYDRATION (Dehydration), GAIT INABILITY (Could not walk) and HEADACHE (Headache) outcome was unknown.            The patient received her first primary vaccine dose on 18-May-2021 with lot number 016C21A. No adverse reactions were reported.  The patient received her second Moderna dose on 16-Jun-2021 with lot number 024C21A.  The patient was reporting side effects after taking the Moderna booster dose. The patient could not pee at all before hospitaliztion. It was reported that the patient could pee now, but the patient was still having a hard time.   The patient reported that she ended up in the hospital from 11-Nov-2022 or 15-Nov-2022 to 20-Nov-2022 with a Foley catheter. The patient reported that she was still confused and she continued to have trouble urinating.  The patient's symptoms of unable to urinate and full bladder had improved.  Company comment: This spontaneous case concerns a 63-year-old female patient, with no relevant medical history reported, who experienced the unexpected serious (Hospitalization) events of Dysuria, Confusional state, Lung infiltration, Dehydration, Gait inability and Headache that occurred within few days after receiving the third dose of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. After taking Moderna vaccine, patient was finding difficulty in passing urine, was hospitalized for 9 days with Foley's catheter. She also had headache, infiltrates in her lungs, dehydration and was not able to walk. She was able to urinate but was still having a hard time. No further information regarding investigations and additional vaccination details were provided. The outcome of the event Dysuria was recovering, Confusional state was not recovered, Lung infiltration, Dehydration, Gait inability and Headache was unknown.The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine in not affected by this report.   This case was linked to MOD-2022-675634 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2022: Significant Live Follow-up information included concomitant medications added, events added and narrative has been updated.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient, with no relevant medical history reported, who experienced the unexpected serious (Hospitalization) events of Dysuria, Confusional state, Lung infiltration, Dehydration, Gait inability and Headache that occurred within few days after receiving the third dose of mRNA-1273 Bivalent BA.4/BA.5 vaccine in COVID-19 vaccination series. After taking Moderna vaccine, patient was finding difficulty in passing urine, was hospitalized for 9 days with Foley's catheter. She also had headache, infiltrates in her lungs, dehydration and was not able to walk. She was able to urinate but was still having a hard time. No further information regarding investigations and additional vaccination details were provided. The outcome of the event Dysuria was recovering, Confusional state was not recovered, Lung infiltration, Dehydration, Gait inability and Headache was unknown.The benefit-risk relationship of mRNA-1273 Bivalent BA.4/BA.5 Vaccine in not affected by this report.