Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site reaction, Pain in extremity, Rhinorrhoea, Sensitive skin
Clinical narrative: Arm started hurting; The injection site is not as sore; but still sensitive; Runny noise started, not a sinus or cold runny nose; This is a spontaneous case was received 19-Jan-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-00231) with additional document received on 20-Jan-2021 (being processed together) and concerned a 81-year-old, female patient.  The patient's medical history and concomitant medications were not reported. It was reported that the patient could not take ten medications.  On 07-Oct-2020, the patient was vaccinated with Fluad unknown if trivalent or quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration, anatomical location: not reported) as influenza prophylaxis. The batch number was not reported.  On the same day, after receiving Fluad, the patient's arm started hurting and injection site was sore.  On an unspecified date in 2020, unknown of time after receiving Fluad, the patient experienced runny nose, but not a sinus or cold runny nose. The patient was not sure exactly when runny noise started. The patient visited her health care provided (HCP) for other issues and men-tioned the arm pain but received no information from HCP regarding the pain.   At the time of initial reporting on 19-Jan-2021, the patient had not recovered form the event of 'pain in arm' since had aches still as of yesterday but had not noticed the pain today. Also, the patient was recovering from the event of 'vaccination site pain' since it was not as sore but still sensitive and of the event 'runny nose' since it was not as bad as it had been. The patient took no treatment measures associated with event.  The reporter did not provide causality assessment but was wondering if this could be side effects from the vaccine.  The case was assessed as non-serious.  Company Comment: A 81-year-old, female patient developed rhinorrhoea, pain in extremity and vaccination site pain after vaccination with the suspect product, Fluad (unknown if trivalent or quadrivalent). There is lack of information regarding the vaccination date and onset date of event rhinorrhoea. Therefore, chronology for this event is unassessable. Advanced age confounds causality. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on unclear time relationship, causality for the event rhinorrhoea is unassessable. Causality for all other events is assessed as possibly related.; Sender's Comments: A 81-year-old, female patient developed rhinorrhoea, pain in extremity and vaccination site pain after vaccination with the suspect product, Fluad (unknown if trivalent or quadrivalent). There is lack of information regarding the vaccination date and onset date of event rhinorrhoea. Therefore, chronology for this event is unassessable. Advanced age confounds causality. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Based on unclear time relationship, causality for the event rhinorrhoea is unassessable. Causality for all other events is assessed as possibly related.