Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Normal pressure hydrocephalus
Clinical narrative: NPH Hydrocephalus; This spontaneous case was reported by a patient and describes the occurrence of NORMAL PRESSURE HYDROCEPHALUS (NPH Hydrocephalus) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NORMAL PRESSURE HYDROCEPHALUS (NPH Hydrocephalus) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Brain surgery) for Normal pressure hydrocephalus. At the time of the report, NORMAL PRESSURE HYDROCEPHALUS (NPH Hydrocephalus) outcome was unknown.            Patient underwent brain surgery for NPH hydrocephalus, in which they put a cordage or hole in back of his skull and put in a shunt to stomach, that was regulated with a magnetic valve. Patient had this drain first at home, where he got 42cc's and second time he got 30cc's. They found that he can go 20yards at a speed increase of 5-7 seconds before 17-20 seconds. Patient took blood thinners previously and off now. COMPANY COMMENT: This spontaneous case concerns a 81-year-old male patient, with no relevant medical history reported, who experienced the unexpected and serious (medically significant and hospitalization) event of Normal pressure hydrocephalus (NPH). The patient received mRNA-1273 dose, which was the patient's 3rd dose of COVID-19 vaccination schedule. TOZINAMERAN was administered for previous vaccinations doses (1st and 2nd). Temporal relationship with mRNA-1273 and potential latency cannot be assessed due to lack of exact dates of vaccination doses and event onset date. It was reported that patient had brain surgery due to NPH with insertion of drainage system (reported AS THEY PUT A CORDAGE OR HOLE IN THE BACK OF THE SKULL, AND PUT IN A SHUNT TO THE STOMACH, THAT IS REGULATED WITH A VALVE, A MAGNETIC VALVE). After the surgery it was observed that "he can go 20 yards, at a speed increase of 5-7 seconds, before he was 17-20 seconds." The patient was not willing to report safety report details; contacted mainly to ask if bivalent Covid vaccine would affect the fact of blood thinners being on hold. No further clinical information or details about course of the event was provided for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 81-year-old male patient, with no relevant medical history reported, who experienced the unexpected and serious (medically significant and hospitalization) event of Normal pressure hydrocephalus (NPH). The patient received mRNA-1273 dose, which was the patient's 3rd dose of COVID-19 vaccination schedule. TOZINAMERAN was administered for previous vaccinations doses (1st and 2nd). Temporal relationship with mRNA-1273 and potential latency cannot be assessed due to lack of exact dates of vaccination doses and event onset date. It was reported that patient had brain surgery due to NPH with insertion of drainage system (reported AS THEY PUT A CORDAGE OR HOLE IN THE BACK OF THE SKULL, AND PUT IN A SHUNT TO THE STOMACH, THAT IS REGULATED WITH A VALVE, A MAGNETIC VALVE). After the surgery it was observed that "he can go 20 yards, at a speed increase of 5-7 seconds, before he was 17-20 seconds." The patient was not willing to report safety report details; contacted mainly to ask if bivalent Covid vaccine would affect the fact of blood thinners being on hold. No further clinical information or details about course of the event was provided for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.