Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Syncope
Clinical narrative: I had fainted with the Moderna shot (Unspecified vaccine); I have hearing problem; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (I had fainted with the Moderna shot (Unspecified vaccine)) in an 84-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 10-Oct-2022, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2023, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2024, received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (I had fainted with the Moderna shot (Unspecified vaccine)) (seriousness criterion medically significant) and HYPOACUSIS (I have hearing problem). At the time of the report, SYNCOPE (I had fainted with the Moderna shot (Unspecified vaccine)) and HYPOACUSIS (I have hearing problem) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. The side effects were fainting the next day, patient was getting dressed, she woke up feeling so good, thought Pfizer has solved her problem because she had fainted with the Moderna shot (Unspecified vaccine) several years back. Shifted to Pfizer thought that, might be better and it was for one or two times but this time she fainted again, and it would have been so easy for somebody feeling as good as she did on awakening to get in the car and tried to start the normal day and they could have killed themselves or other people. Patient was not taking any other medication.  Patient stated, she did not take any other vaccine that day. she has learned the hard way not to do two at once." When probed for details for previous doses, She stated," The first Pfizer shot that she got was, it looks like 9-Mar-24, this was the last one. The one before that was 10-10, they were out of water here. The one before that was 23 and that was 7-Oct and 22 was another Pfizer, 10-Oct." She had no other treatment from a very long time, probably since the last shot, the shot before this one."  No treatment information was reported. Company Comment: This is a spontaneous case concerning 84-year-old female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Syncope which occurred on an unknown date and with unknown latency after a dose of mRNA-1273 vaccine Patient also received other 3 does of Tozinameran for COVID-19 vaccination schedule. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact