Age: 41.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Musculoskeletal pain, Pain in extremity, Peripheral swelling, Pharyngeal oedema, Throat irritation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 41-year-old male patient who received FLULAVAL QUADRIVALENT for prophylaxis. Co-suspect products included gabapentin unknown for antinuclear antibody positive, ADACEL for prophylaxis and PLAQUENIL for antinuclear antibody positive. Concurrent medical conditions included blood pressure high, anxiety and depression. Concomitant products included Aspirin and hydrochlorothiazide. On 1st November 2016, the patient received FLULAVAL QUADRIVALENT. In March 2017, the patient started gabapentin at an unknown dose and frequency. In July 2018, the dose was changed to 300 mg 3 times daily (900 mg daily). On 14th October 2016, the patient received ADACEL. In March 2017, the patient started PLAQUENIL at an unknown dose and frequency. In December 2016, less than a year after receiving FLULAVAL QUADRIVALENT and gabapentin, the patient experienced shoulder pain (serious criteria disability), back pain (serious criteria disability), muscle strain (serious criteria disability) and influenza-like symptoms (serious criteria disability). In March 2017, the patient experienced diabetes (serious criteria disability and GSK medically significant), blurred vision (serious criteria disability), blood sugar increased (serious criteria disability), antinuclear antibody positive (serious criteria disability), enzyme-linked immunosorbent assay (serious criteria disability) and testosterone decreased (serious criteria disability). In January 2018, the patient experienced swelling of feet (serious criteria disability) and throat swelling (serious criteria disability). In July 2018, the patient experienced bedridden (serious criteria disability). In October 2018, the patient experienced heart rate increased (serious criteria disability). On an unknown date, the patient experienced autoimmune disorder (serious criteria disability and GSK medically significant), burning in throat (serious criteria disability), anxiety aggravated (serious criteria disability), depression aggravated (serious criteria disability), memory loss (serious criteria disability), tremor of hands (serious criteria disability), sleep excessive (serious criteria disability), activities of daily living impaired (serious criteria disability), finger crushing (serious criteria GSK medically significant), pain in arm and allergic reaction to drug excipient. The patient was treated with drug used in diabetes (Diabetes Medication (Nos)) and Testosterone Injection. Gabapentin was discontinued (Dechallenge was unknown). PLAQUENIL was discontinued (Dechallenge was unknown). In August 2018, the outcome of the bedridden was recovered/resolved. On an unknown date, the outcome of the autoimmune disorder, diabetes, shoulder pain, back pain, muscle strain, influenza-like symptoms, burning in throat, swelling of feet, blurred vision, blood sugar increased, heart rate increased, anxiety aggravated, depression aggravated, throat swelling, antinuclear antibody positive, enzyme-linked immunosorbent assay, testosterone decreased, memory loss, tremor of hands, sleep excessive, activities of daily living impaired, finger crushing, pain in arm and allergic reaction to drug excipient were unknown. It was unknown if the reporter considered the autoimmune disorder, diabetes, shoulder pain, back pain, muscle strain, influenza-like symptoms, burning in throat, swelling of feet, blurred vision, blood sugar increased, heart rate increased, anxiety aggravated, depression aggravated, throat swelling, antinuclear antibody positive, enzyme-linked immunosorbent assay, testosterone decreased, memory loss, tremor of hands, bedridden, sleep excessive, activities of daily living impaired, finger crushing, pain in arm and allergic reaction to drug excipient to be related to FLULAVAL QUADRIVALENT and gabapentin. Additional details were provided as follows: This was a potential legal case. The patient had reported these events to VAERS around May 2018. The patient called seeking information about a vaccine received at Emergency room on 14th October 2016 later identified as ADACEL. He was seen at the Emergency room for a smashed finger. This had already been identified in a letter to him from the hospital. He noted from the ER visit and that vaccination he experienced severe left arm pain down into his wrist. The patient at the 2-week follow-up appointment with his physician he received a FLULAVAL QUADRIVALENT vaccine on or around 1st November 2016. He noted in December 2016, he had flu like symptoms that would not really resolve. He noted upper shoulder and back pain that his physician diagnosed as muscle strain and he was given a trigger point injection that did not help. In February 2017, the patient's physician did some blood tests because he still had the flu like symptoms. In March 2017, his blood work came back with a positive antinuclear antibody (ANA) and soluble mesothelin related peptide (SMRP) antibodies and was prescribed PLAQUENIL and gabapentin. The patient noted the gabapentin was gradually increased over the next year and a half. The patient was told he was diabetic and had low testosterone. He noted he had also had some blurry vision and his blood sugars were high. He stated he was placed on medications for diabetes and testosterone injections. He also noted worsening of past known issues of anxiety and depression. He noted the PLAQUENIL and gabapentin increases were making cognitive issues of memory and hand trembling that also started after the vaccines worse. In July 2018, the patient was not better, his gabapentin was increased to 600mg three times daily. He said that caused him to sleep for days and stay up for days because he would then miss the doses. He noted he was also seen at local doctor for foot swelling in January 2018 and had been seen at the local ER for throat swelling, which he noted as symptoms of the PLAQUENIL and gabapentin. He stated he was bedridden for 2 months from July 2018 to August of 2018. He had been taken off all medication except blood pressure medication since 10th October 2018. The patient also had experienced increase heart rate since October 2018. He noted the doctor had told him he had an autoimmune disorder but had not said what that was. The patient was doing some better being off the medications now. He continued to take his blood pressure medication and aspirin. The patient noted he had a disability attorney and stated he had been unable to work. The patient mentioned he had an attorney, but noted this was a disability attorney. The patient also stated if he found out he was given the wrong vaccine, he would get an attorney. The patient's story was all over the place and when asked about identification of initial ER product he said he did not know, then had a letter from Hospital. The patient noted the events initially were after the ER vaccine the cognitive events were due to the gabapentin and PLAQUENIL, but when the FLULAVAL vaccine identified he stated all the events began at the same time, but the gabapentin and PLAQUENIL made the conginitive issues worse. The patient also mentioned about potential mercury concern of flu vaccine. The reporter provided contact details of the physician and consented to be followed up. It was unknown if the reporter considered the autoimmune disorder, diabetes, shoulder pain, back pain, muscle strain, influenza-like symptoms, burning in throat, swelling of feet, blurred vision, blood sugar increased, heart rate increased, anxiety aggravated, depression aggravated, throat swelling, antinuclear antibody positive, enzyme-linked immunosorbent assay, testosterone decreased, memory loss, tremor of hands, bedridden, sleep excessive, activities of daily living impaired, pain in arm and finger crushing to be related to ADACEL and PLAQUENIL. This case was linked with US2018221764, reported by the same reporter.