Sex: F
Vaccine: FLUR4, HEP, PPV
Symptoms: Injection site swelling, Insomnia, Lymph node pain, Lymphadenopathy, Oedema peripheral
Clinical narrative: Initial unsolicited report received from health authority (reference number: 723858) on 03-Apr-2018. This case involves a 56-year-old female patient who received a first dose of FLUBLOK QIV (batch number: QFAA1703, expiry date not reported) intramuscularly in the right arm, first dose of PNEUMOVAX (Manufacturer: Merck) (batch number: N011305, expiry date was not reported) intramuscularly in the left arm and first dose of ENGERIX-B (Manufacturer: Glaxosmithkline) (batch number: DA92R, expiry date was not reported) intramuscularly in the right arm on 30-Sep-2017. The patient's medical history was reported as hypertension, hyperlipidemia and hypothyroidism. Concomitant medications included Losartan Potassium (Losartan), Levothyroxine Sodium (Levothyroxine), Rosuvastatin, Hydrochlorothiazide (Hctz), Ibuprofen, Lansoprazole, Loratadine (Loratidine), Calcium Citrate, Multivitamins (Multivitamin). On 01-Oct-2017, one day post vaccination, the patient experienced chills at about 5:00 pm, felt fatigued at 7:00 pm, Injection site pain and lymphadenopathy. On 02-Oct-2017, two days post vaccination, the patient experienced swollen and painful axillary lymph nodes (lymph node pain), left greater than right, and swollen and painful biceps, left greater than right, injection site swelling and tinnitus. On the same day in the evening, right side of face (cheek) flushed, but not left side and chills remained for an hour after retiring and prevented sleep (Insomnia). It was reported that, patient had no fever noticed or recorded. It was also reported that on 03-Oct-2017, three days post vaccination the patient still experienced tender (tenderness) and swelling in axilla and pain in biceps, still left side greater than right. It was reported that, patient had an appointment with the physician and had test for blood pressure, temperature, Palpated axilla, Ordered chest x-ray with results normal. On 04 October 2017 patient still had some swelling in axilla and tenderness in biceps and was not so fatigued and 05 October 2017 patient was well enough to go to work. And by 30 October 2017 bilateral tinnitus remains. Other laboratory investigation and corrective treatment were not reported. The outcome of events was reported as not recovered. This case was reported as serious due to disability. List of documents held by sender: none.; Sender's Comments: The patient experienced lymphadenopathy, lymph node pain, insomnia, flushing, tinnitus along with multiple other events post vaccination with FLUBLOK QIV, PNEUMOVAX and ENGERIX-B. Time to onset was compatible. the patient had medical history of hypertension, hyperlipidemia, and hypothyroidism. Chest Xray was normal but a complete lab tests with etiological work up would be required to identify the cause of the events. There is apossibility that the events were related to pre eisting medical conditions except for vaccination site reactions. An underlying infectious etiology could also be a causative factor. Additional information regarding lab tests ruling out infectious etiology and patients condition at the time of vaccination would be required to further assess the case. Based upon reported information the role fo one vaccine can not be assessed.