Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Abdominal pain upper, Alanine aminotransferase normal, Albumin globulin ratio, Antinuclear antibody negative, Aspartate aminotransferase normal
Clinical narrative: This spontaneous case, initially received on 20-Dec-2017, was reported by other non-health professional and concerns a 72-year-old, elderly, male patient. The historical condition included trigger finger (unspecified date) and had neither lupus nor rheumatoid. The patient's current conditions included allergies to SEPTRA, KEFLEX, isoniazid and high cholesterol. The concomitant medications included simvastatin for slightly elevated cholesterol, fish oil, vitamin B12, vitamin D3 and calcium for unknown indications. On 07-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). On the same day, after vaccination, the patient experienced tenderness at the injection site. On 07-Oct-2017, after 1 month of vaccination, the patient developed weakness of legs and pain all over body up to shoulders and later, he felt pain in arms. The patient had difficulty in moving and bending. The patient was diagnosed with polymyalgia rheumatica and was treated with prednisolone. On 20-Nov-2017, at 12:36 hrs, the CRP, Quant was 12, sedimentation rate-Westergen was 41. On the same day, at 16:35 hrs, the patient's lab tests included, C-reactive protein, Quant (CRP) which showed 133.7, sedimentation rate-Westergen was 50, cyclic citrullinated peptide (CCP) antibodies IgG/IgA was 9, rheumatoid arthritis (RA) latex turbid was 13.4, antinuclear antibodies, immunofluorescence (IFA) was found to be negative (units were not provided). On 05-DEC-2017, at 11:29 hrs, haemoglobin A1C was 6, CRP was 69.23, sedimentation rate was 64. The dose of prednisone was increased to 30 mg (5 mgx6) oral every day. On an unspecified date (reported as 2 weeks ago), the patient had dull pain in stomach just under rib cage (more prevalent in morning) and abnormal bowel habit (reported as change in stool). On 20-Dec-2017, at 12:36, CRP Quant was 12, sedimentation-rate Westergren was 41. On 25-Jan-2018, at 14:35 hrs, CRP Quant was 16.5, sedimentation rate-Westergren was 12, haemoglobin A1c was 5.8, comprehensive metabolic panel included: albumin/globulin (A/G) was 1.6, serum albumin was 3.9, serum alkaline phosphatase was 63, alanine transaminase (ALT) was 14, aspartate transaminase (AST) was 17. The dose of prednisone was tapered to 20 mg (4 tablet orally every day). After the dose of prednisone was reduced, the patient had recovered from the event-stomach pain. The reporter stated that, the oil itself might cause many problems associated with autoimmunity and further specified squalene (adjuvant to FLUAD vaccine) might cause autoimmune conditions. At the time of this report, the patient had not taken any medication to which he was allergic [in the past 6 weeks (as reported)]. At the time of this report, the patient was recovering from the events polymyalgia rheumatic, injection site pain, weakness, mobility decreased and pain. The patient reported that, he took treatment after consulting rheumatologist and was feeling better. The outcome of the event- abnormal stools was not reported. The reporter assessed this case as non-serious and events as related to the suspect vaccine. Non-significant follow up received on 21-Dec-2017: Added reporter's comment. The narrative was amended accordingly. Follow-up received from the reporter on 15-Jan-2018: Added historical condition (trigger finger), current condition (allergy to SEPTRA, KEFLEX, isoniazid), indication (slightly elevated cholesterol) and dose (10 mg) for the drug simvastatin. The diagnosis was confirmed as polymyalgia rheumatica (hence, deleted the event rheumatoid arthritis). The patient reported that, he took treatment under rheumatologist and was feeling better. Narrative was amended accordingly. Follow-up received from the reporter on 29-Jan-2018: Added new abdominal pain and abnormal stools. At the time of this report, the patient had not taken any medication to which he was allergic, in the past 6 weeks (as reported). Relevant lab investigations (antinuclear antibody, cyclic citrullinated peptide (CCP) was, C-reactive protein, RBC sedimentation rate, rheumatoid factor, immunoassay antibody, immunoassay non-antibody [units and normal values were not provided] performed on 20-Nov-2017. The patient had recovered from the event-stomach pain. The outcome of the event- abnormal stools was not reported. Narrative was amended accordingly. Follow-up received from the reporter as 22-Feb-2018: Added concomitant medication relevant investigations and new events [C-reactive protein increased, sedimentation rate-Westergen was increased and haemoglobin A1c was increased]. Narrative was amended accordingly.