Sex: F
Vaccine: FLU4
Symptoms: Agitation, Asthenia, Cough, Dyspnoea, Malaise
Clinical narrative: Felt weak and in pain; Felt weak and in pain; Both arms became swollen and felt very stiff; Both arms became swollen and felt very stiff; Had difficulty breathing; Cough; She felt ill/felt sick; Patient being agitated and upset; Patient being agitated and upset; This spontaneous case was received on 09-Oct-2020 from other non-health professional (consumer) via Health Authority (reference number: SEQW20-03334) and concerned a female patient of unknown age (reported as retiree).  The patient's medical history and concomitant medications were not reported.  On 27-Aug-2020, the patient was vaccinated with Afluria Quadrivalent (Influenza vaccine, dose: 0.5 ml, anatomical location: arm and route of administration: not reported) for protection against seasonal influenza. The batch number was not reported.  On the same day, almost immediately after receiving Afluria Quadrivalent, the patient felt ill. Also, the patient felt weak and in pain, both arms became swollen and felt very stiff. She developed a cough, felt sick and had difficulty breathing. The patient's healthcare provider was aware of her condition and had prescribed her multiple antibiotics, such as ten days' worth of Levaquin (levofloxacin), five days' worth of a Z-pak (azithromycin) and guaifenesin and nothing had helped, and he had no idea what to do. These issues have persisted to date.  On an unknown date in 2020, the patient was agitated and upset.   At the time of initial reporting on 10-Oct-2020, the patient had not recovered for the events.   The reporter did not provide causality assessment.   The reporter assessed this case as non-serious.  Company Comment: A patient of unknown age was administered Afluria Quadrivalent vaccine. On the same day, almost immediately after receiving vaccine the patient experienced musculoskeletal stiffness, peripheral swelling, pain and asthenia. The patient also developed cough, dyspnoea and malaise. Chronology is plausible. It was reported that the patient's healthcare provider was aware of her condition and had prescribed her multiple antibiotics, such as Levaquin (levofloxacin), azithromycin and guaifenesin and nothing had helped. On an unknown date in 2020, the patient experienced agitation and emotional distress. More information regarding patient's medical history and concomitant medications is needed. Causality is unassessable for agitation and emotional distress, due to unclear chronology and lack of information regarding circumstances surrounding these events. Due to plausible chronology, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related for remaining events. (defaults to "related" in the safety database for reporting purposes); Sender's Comments: A patient of unknown age was administered Afluria Quadrivalent vaccine. On the same day, almost immediately after receiving vaccine the patient experienced musculoskeletal stiffness, peripheral swelling, pain and asthenia. The patient also developed cough, dyspnoea and malaise. Chronology is plausible. It was reported that the patient's healthcare provider was aware of her condition and had prescribed her multiple antibiotics, such as Levaquin (levofloxacin), azithromycin and guaifenesin and nothing had helped. On an unknown date in 2020, the patient experienced agitation and emotional distress. More information regarding patient's medical history and concomitant medications is needed. Causality is unassessable for agitation and emotional distress, due to unclear chronology and lack of information regarding circumstances surrounding these events. Due to plausible chronology, causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related for remaining events. (defaults to "related" in the safety database for reporting purposes)