PV Gateway— overviewStaff sign in

Report a side effect

Report a suspected side effect as a health professional, patient or relative. No account needed.

You can report even if some details are unknown. If you need urgent medical help, contact a healthcare professional or emergency services.

Fields marked with an asterisk are required. For identifier groups, provide at least one of the marked fields.

Case information

C.1
Day 0 is the earliest date the four minimum criteria reached any holder / operator employee or subcontractor, not the data-entry or assessment date. Only significant follow-up on a previously reported case starts a new reporting clock.
C.1.3
C.1.4
C.1.5

Updating this date on an initial report does not extend its original deadline.

Primary source (reporter)

C.2.r
Provide at least one of the marked reporter identifiers: name, organisation, email or telephone.
C.2.r.1.2
C.2.r.1.4
C.2.r.2.1
C.2.r.3
C.2.r.2
C.2.r.2.7
C.2.r.4

If unknown, the guide permits a patient / consumer default. This does not establish medical confirmation.

Patient

D
Provide at least one of the marked identifiers: initials / ID, age, age group or known sex. Do not enter directly identifying data.
D.1
D.2.2
D.5
D.2.3
D.3
D.4
D.7.2

Reactions / events

E.i
One entry per reaction. Seriousness is assessed per reaction and drives the reporting clock.

Reaction E.i #1

E.i.4
E.i.5
E.i.7
Seriousness criteria · E.i.3.2
a
b
c
d
e
f

Medicinal products

G.k
At least one suspect or interacting product is required. For each entry, provide a product name or active substance.

Product G.k #1

Suspect

The registry supplies product identity and the linked holder, not expected reactions or exposure data. If unavailable, enter the reported name below for CNPM matching.

G.k.2.2
G.k.1
G.k.2.3
G.k.4.r.1
G.k.4.r.10
G.k.4.r.7
G.k.4.r.4
G.k.4.r.5
G.k.8
G.k.7.r.1

Narrative & assessment

H
A chronological clinical summary including course, treatment, dechallenge / rechallenge and relevant tests.
Special situations
H.1
H.2

Review report

Case validity

0/4 minimum criteria
  • Identifiable reporter — missingC.2.r — identifier (E2D) plus qualification and country (E2B)
  • Identifiable patient — missingD.1–D.5 — initials, age, age group or sex
  • Adverse reaction / event — missingE.i.1 — at least one reported term
  • Suspect medicinal product — missingG.k.1 = 1 or 3 with product or substance name

Seriousness & reporting

Non-serious

Follow-up required — no legal clock

Recipient
CNPM
Channel
Incomplete / record-only report
Follow-up
Priority 3 — Non-serious case with no special situation.

Retained for follow-up. The reporting clock starts only when all four minimum criteria are available and the report qualifies as an ICSR.