Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Oropharyngeal pain, Pain, Paraesthesia, Pyrexia
Clinical narrative: Secondary bronchitis and laryngitis; Secondary bronchitis and laryngitis; Paraesthesia; Influeza infection cannot be completely ruled out; Mycoplasma pneumoniae infection; This is a spontaneous case, initially received from other health care professional on 18-Nov-2019, with additional information received on 25-Nov-2019 (being processed together), concerning a 38-year-old, female patient.   The patient's medical history included unspecified flu vaccine with no adverse reaction reported.   The patient's concomitant medications were not provided.   On 06-May-2019, the patient was administered Afluria Quadrivalent [influenza vaccine, expiration date: Feb-2020, batch number reported as 49601-02503, route of administration: intramuscular, dose: 0.5 ml and anatomical location: upper right arm as reported] as active immunization against influenza disease (prophylaxis).  On an unspecified date in 2019, at unknown time after vaccination, the patient developed mycoplasma pneumoniae infection.  On 16-Nov-2019 in the morning, six months and ten days after vaccination, the patient returned from a trip with a sore throat and cough. The patient's symptoms worsened as the day progressed and included pyrexia, body aches, nausea, and fatigue. The patient also experienced paraesthesia.   On the same day, six months and ten days after vaccination, the patient started therapy with oseltamivir.  On 18-Nov-2019, in the morning, the patient went to her general practitioner (GP) who confirmed the diagnosis of influenza. The patient's GP took a throat swab. The results showed that influenza A and influenza B were not detected, while mycoplasma pneumonia was detected. It was reported that influenza virus was not detected, and that initial influenza infection cannot be completely ruled out due to a close contact developing influenza 1.5 days after contact with the patient (with no other likely exposure to influenza virus in timeframe for incubation as reported). According by the throat swab, it was also reported that initial influenza infection cannot be confirmed due to lack of detection.   On 21-Nov-2019, five days after the onset, the patient recovered from the event paraesthesia, and the symptoms of pyrexia and body aches were also resolved.   On 22-Nov-2019, the patient developed a secondary bronchitis and laryngitis.  On 25-Nov-2019, the patient started on roxithromycin, at a dose of 150 mg administered two times per day as corrective treatment for the bronchitis and laryngitis.   On 25-Nov-2019, at the evening, the patient started treatment with clarithromycin, at a dose of 500 mg administered two times per day for 7 days and cefuroxime, at the dose of 250 mg two times per day for 5 days.  On 27-Nov-2019, the symptoms of sore throat, nausea and fatigue were resolved.  On 30-Nov-2019, the patient stopped treatment with cefuroxime.  0n 02-Dec-2019, the patient stopped treatment with clarithromycin.  At the time of this report, the patient was recovering from the events of influenza, bronchitis and laryngitis. It was that reported symptom of cough, bronchitis and laryngitis had not fully resolved. The outcome of the event mycoplasma infection was not reported.  The events of mycoplasma infection and influenza were considered serious due to the criterion of medical significance.  The reporter assessed all events to be related to Afluria Quadrivalent, as it was reported that she experienced 'lack of efficacy with Afluria Quad'.   Follow up received by other health care professional on 02-Dec-2019: Details about Afluria Quadrivalent vaccination were provided, test results were provided, updated outcome for the events was provided, new event of mycoplasma pneumoniae infection. Treatment measures were provided. Narrative amended accordingly.  Company Comment: The patient experienced mycoplasma infection, influenza, paraesthesia, bronchitis and laryngitis after vaccination with the suspect product Afluria Quadrivalent. Chronology is very unsuggestive due to very long event onset latency, more than 6 months. Throat swab showed that influenza A and influenza B were not detected, while mycoplasma pneumonia was detected. Patent's exposure to infective agents may provide more plausible alternative aetiology. No medical history and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as unlikely related.; Reporter's Comments: I'm writing to report a case of lack of efficacy with Afluria Quad, for which unfortunately the patient is me.; Sender's Comments: The patient experienced mycoplasma infection, influenza, paraesthesia, bronchitis and laryngitis after vaccination with the suspect product Afluria Quadrivalent. Chronology is very unsuggestive due to very long event onset latency, more than 6 months. Throat swab showed that influenza A and influenza B were not detected, while mycoplasma pneumonia was detected. Patent's exposure to infective agents may provide more plausible alternative aetiology. No medical history and concomitant medications were reported. Considering all the above mentioned, causality between suspect product and the events is assessed as unlikely related.