The image needs to be updated to reflect that 1) the first swimlane is no longer a participant, but a patient; 2) the second swimlane would not use CTMS system, but the hospitals/clinics EHR to record and may transmit via phone, fax, or online (see instructions below); 3) for the third swimlane, I don't see any associated direct lines from the patient to the manufactured or the site/provider. Also, the manufacturer may have a call center or online reporting systems for such cases. Therefore, it should be similar to the site/provider within the workflow process (i.e., recording the AE, etc.)

Note: MedWatch 3500 does not cover vaccines which are reported under  Vaccine Adverse Event Reporting System (VAERS). Similar actions to be taken for the first image under pre-market. 

References:

https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500 (MedWatch 3500 instructions)