Sex: F
Vaccine: PNC13
Symptoms: Hot flush, Inflammation, Injection site bruising, Injection site pain, Insomnia
Clinical narrative: This is a solicited report from a non-Pfizer sponsored program, based on information received by Pfizer (manufacturer control number: 18K-163-2488003-00). Solicited report by a consumer of a 50 year old female with events of could have nocturnal seizures and non-serious fatigue, immune system down, reaction to PREVNAR 13 vaccine, eyelid drooping, inflammation of cartilage between ribs, hands and achilles tendon, unexpected clinical benefit/HUMIRA worked well with the medication MESTINON used to treat myasthenia gravis, ankles swelling/joint swelling, spinal stenosis, difficulty sleeping, hot flashes, stiffness in joints, dry eyes, blood work showed out of whack and one reading was down 0.02, Achilles tendon pain make movement painful, lack of effect/no results with HUMIRA, intermittent headaches/headache, worsening of psoriatic arthritis symptoms, red dots on underside of arm and knuckles, shaking, hands were painful and difficulty eating with handling knife and fork/bottom of feet were painful/fingers hurt, generalized pain, muscle weakness, possible fever, psoriasis not improving, joint pain not improving, tingling fingers, injection burns and injection site bruising with HUMIRA 40mg/0.4ml. The patient had a relevant medical history of mitochondrial encephalopathy-genetic since birth, Sjogren's syndrome, high blood pressure, neuropathy, thyroid disease with three nodules, demyelinating disorders, facial drooping, stroke, endometriosis, hysterectomy due to endometriosis, Raynaud's syndrome, myasthenia gravis, hypermobility syndrome and eye drooping. In 2018, the patient experienced could have nocturnal seizures, immune system down, reaction to PREVNAR 13 vaccine, eyelid drooping, unexpected clinical benefit/HUMIRA worked well with the medication MESTINON used to treat myasthenia gravis, ankles swelling/joint swelling, spinal stenosis, difficulty sleeping, hot flashes, dry eyes, blood work showed out of whack and one reading was down 0.02, red dots on underside of arm and knuckles, shaking, hands were painful and difficulty eating with handling knife and fork/bottom of feet were painful/fingers hurt, generalized pain, muscle weakness, possible fever, psoriasis not improving, joint pain not improving, tingling fingers, injection burns and injection site bruising. On 10Aug2018, the patient experienced lack of effect/no results with HUMIRA. In Sep2018, the patient experienced fatigue. On 06Sep2018, the patient experienced inflammation of cartilage between ribs, hands and Achilles tendon, Achilles tendon pain make movement painful, intermittent headaches/headache and worsening of psoriatic arthritis symptoms. On 13Oct2018, the patient experienced stiffness in joints. In 2018, the hot flashes and possible fever resolved. PREVNAR 13 was also considered suspect. With her pre HUMIRA history of mitochondrial encephalopathy, the patient stated that she could have nocturnal seizures. The patient had worsening of symptoms since beginning HUMIRA therapy including inflammation of cartilage between ribs, hands and Achilles tendon pain making movement very painful. She took ULTRAM and FLEXERIL routinely for that type of flare up. She acted out in her dreams like she was sewing something in mid-air. She had no results with HUMIRA. She had no improvement in symptoms if anything, pain was worse. She had been on HUMIRA for five weeks with no improvement till reporting. Her symptoms might actually be worse. She took a PREVNAR 13 vaccine the other day and they thought because of all her other conditions it was the perfect storm to make her symptoms flare up, her pain increased with joint inflammation, and she was having a hard time moving. She also reported muscle weakness and having to use a cane to get around her house. Her physician gave her steroids and that helped her get back to baseline. The part of her immune system was down and coupled with HUMIRA she was being very careful going in public but thought that contributed to her reaction to the PREVNAR vaccine. She got hot flashes during the day sometimes but thought that she might have also been a bit feverish during the reaction to the vaccine. She got headaches for a couple days after each injection. She still had problems the day after working in garden with joint pain, swelling and difficulty moving. The bottom of her feet was extremely painful and she had difficulty walking. Her hands were painful with difficulty eating with handling knife and fork. She had generalized pain. She did physical therapy for joint pain. She had pain in her Achilles tendon and was wearing combat boots for support as the HUMIRA had not worked for her pain. She had difficulty sleeping. She drank lemon tea and raspberry leaves tea for menstrual cramping and used Valerian root and passion flower as needed for sleep. She thought that HUMIRA worked well with the medication MESTINON used to treat myasthenia gravis. She noticed it because her eyes were getting dry and it was because they were actually open all the way for once. Psoriasis was not improving and joint pain was not improving. The patient was treated with Passion flower, FLEXERIL, ULTRAM and Valerian root. Causality for HUMIRA 40 mg/0.4ml: The reporter's causality for the event(s) of could have nocturnal seizures, eyelid drooping, inflammation of cartilage between ribs, hands and Achilles tendon, spinal stenosis, difficulty sleeping, worsening of psoriatic arthritis symptoms, Achilles tendon pain make movement painful onset 06Sep2018, hands were painful and difficulty eating with handling knife and fork/bottom of feet were painful/fingers hurt, generalized pain, psoriasis not improving, joint pain not improving, tingling fingers and injection burns was not provided; the reporter's causality for the event(s) of fatigue, reaction to PREVNAR 13 vaccine, unexpected clinical benefit/HUMIRA worked well with the medication MESTINON used to treat myasthenia gravis, ankles swelling/joint swelling, hot flashes, dry eyes, blood work showed out of whack and one reading was down 0.02, Achilles tendon pain make movement painful onset 06Sep2018, lack of effect/no results with HUMIRA, intermittent headaches/headache, red dots on underside of arm and knuckles, shaking, muscle weakness and injection site bruising with HUMIRA 40mg/0.4ml was a reasonable possibility. The reporter's causality for the event(s) of immune system down, stiffness in joints and possible fever with HUMIRA 40mg/0.4ml was no reasonable possibility. Regulatory Authority's opinion is that there is no reasonable possibility that the events of could have nocturnal seizures, fatigue, reaction to PREVNAR 13 vaccine, eyelid drooping, inflammation of cartilage between ribs, hands and Achilles tendon, ankles swelling/joint swelling, spinal stenosis, difficulty sleeping, hot flashes, stiffness in joints, dry eyes, Achilles tendon pain make movement painful onset 06Sep2018, lack of effect/no results with HUMIRA, worsening of psoriatic arthritis symptoms, Achilles tendon pain make movement painful onset 06Sep2018, shaking, hands were painful and difficulty eating with handling knife and fork/bottom of feet were painful/fingers hurt, generalized pain, muscle weakness, possible fever, psoriasis not improving, joint pain not improving and tingling fingers are related to HUMIRA 40mg/0.4ml. Regulatory Authority's opinion is that there is a reasonable possibility that the events of immune system down, unexpected clinical benefit/HUMIRA worked well with the medication MESTINON used to treat myasthenia gravis, intermittent headaches/headache, red dots on underside of arm and knuckles, injection burns and injection site bruising are related to HUMIRA 40mg/0.4ml. Regulatory Authority's opinion is that the event of blood work showed out of whack and one reading was down 0.02 is not assessable. Relevant Laboratory and Other Diagnostic Tests: 2018 Blood Work: Out of whack and one reading is down 0.02. Change History: On 02Oct2018, received updates to medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures and narrative description. The serious event of "Could have nocturnal seizures" was added. The event of "Lack of effect" was amended to "Lack of effect/No results with HUMIRA". On 13Oct2018, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. On 17Oct2018, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. On 23Oct2018, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology and narrative description. The event of "Intermittent headaches" was amended to "Intermittent headaches/Headache". On 30Oct2018, received updates to study information, event information, reporter opinion of causality, company opinion of causality and narrative description. The reporter's assessment of the causal relationship of all the events with the suspect product pneumococcal 13-val conj vac (dipht crm197 protein) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch number has been requested. Sender's Comments: Based on the available information and known product safety profile the events seizure, fatigue, fever and difficulty sleeping were possibly related to PREVNAR 13 vaccine based on an implied temporal association and known product safety profile. The events Lack of drug effect/no results with HUMIRA, intermittent headaches/headache, red dots on underside of arm and knuckles, injection burns and injection site bruising are attributed to HUMIRA and assessed as unrelated to PREVNAR 13. All other reported events more likely represent intercurrent or underlying medical conditions that were not related to PREVNAR 13. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.