Sex: F
Vaccine: COVID19
Symptoms: Sensitivity to weather change, Sinus disorder, Stress, Ulcer
Clinical narrative: she was very stressed and was admitted to a hospital; Pulled a muscle in her back; Environmental allergies are acting up; Her ulcers and sinuses are acting up/Environmental allergies are acting up; Bad episode; woke up with an episode; Her ulcers and sinuses are acting up; she has multiple ulcers; Her ulcers and sinuses are acting up; she has multiple ulcers; Her ulcers and sinuses are acting up; Due to the colder weather, her legs and feet had been having trouble resisting the cold; Legs and feet have been having trouble resisting the cold; Potassium was very low; Pneumonia; Pain; Infections in her ears; Infections in her ears and throat; Could not move around much; Continued to be pretty weak; could not stand for a shower; Had a hard time clipping dog leash and had to use 2 hands because her hands were weak; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022XER00035.  On 19Jan2022, a solicited report was received from a consumer, via a company representative, regarding a 73-year-old female who was being treated with KEVEYIS 50 mg (dichlorphenamide). On 21Feb2022 and 18May2022, additional information was received from a consumer, via company representatives (panther x case id: Unknown). On 25May2022, additional information was received from a consumer, and covid-19 vaccine (Pfizer) was added as co-suspect. On 22Jul2022, 19Oct2022 and 18Nov2022, additional information was received from a consumer, via company representatives (panther x case id: Unknown). On 27Mar2023, additional information was received from a consumer, via a company representative (panther x case id: Unknown), and based on the information, the case was upgraded to expedited (serious, unexpected, unknown causality). Medical history included hyperkalemia, periodic paralysis, environmental allergies, ulcers and sinuses acting up, abnormal cholesterol, use of an unspecified medication for osteoporosis that made her have episodes, primary myotonia congenita, quadriplegic for close to 10 years (relative to 25May2022) and without keveyis she would regress to quadriplegic (also reported as a quadriplegic in disguise), a very bad eater, heavy, and no trunk muscles. Concomitant products included: unspecified daily vitamins, vitamin D, garlic for cholesterol, fish oil, vitamin C, and collagen. On an unspecified date in 2017 (reported as 28Apr2017 and 03May2017), the patient started treatment with keveyis 50 mg at 1 tablet (50mg), 3x/day, orally for hyperkalemia and periodic paralysis. On an unspecified date, the patient started treatment with covid-19 vaccine (Pfizer) at an unspecified dose, frequency, and route of administration for an unspecified indication. On 12Jan2022, after starting the product, the patient(s) environmental allergies, ulcers, and sinuses were "acting up," but she had  seen her doctor for it (environmental allergies). Due to the colder weather, her legs and feet had been having trouble resisting the cold. On an unspecified date in Feb2022, the patient had covid. It was really mild, and she had a headache, which made her believe it was covid. On the 5th day, she had a positive home test, and on day 7 and 10, she was negative. The covid only lasted about 7 days. It was  noted that she had 3 shots of Pfizer covid vaccine, and she anticipated getting a 4th booster in the last week of May2022 or first week of Jun2022. On 07May2022, the patient had a bad episode. On 08May2022 (reported as Special(s) day), she woke up with an episode, but it resolved by the morning. However, she continued to be pretty weak after that. She could not move around much and could barely get her dog on his leash to let jim out, which was further described that she had to use 2 hands because her hands were weak. Additionally, she could not stand for a shower. As a treatment, she used her orthopedic-like hospital bed, and she raised her head and made her legs comfortable. She also used a massager and a leg lifter to move her legs in bed. The episode lasted until 12May2022. This was a pretty bad episode, but it seemed to work itself out. She was normally very stable on the product and this was weird for her to experience. It was noted that the keveyis "knocked it out" in a week. She was able to stand and transfer since taking keveyis and stand for a shower daily. Her PT (physical therapist) encouraged her to do "this" to keep her bones strong. All of the symptoms resolved within about a week. On an unspecified date in 2022, the patient woke up with some pain, but she was not taking Percocet (oxycodone hydrochloride and acetaminophen) anymore. She was using medical marijuana instead and that was helping her more and did not give her an upset stomach. On an unspecified date in 2022, she had infections in her ears and throat, and she had some congestion. On an unspecified date in 2022, the patient "just" (relative to 18Nov2022) got over pneumonia. Additionally, her potassium was very low so they stopped the keveyis for a few days. Her potassium had equalized "now" (relative to 18Nov2022) that she was done with pneumonia. Subsequently, she continued to take keveyis again. Additionally, the patient pulled a muscle in her back, but she felt that it was not related to the keveyis or pneumonia. On 21Mar2023, "levels" were very high, and she was very stressed and was admitted to a hospital. On 23Mar2023, she was discharged. As of 27Mar2023, treatment with keveyis was ongoing. The outcomes of the infections in her ears and throat, pulled muscle, congestion, stressed, and levels were very high were not reported. The outcome of pain was improved. No additional information was provided.  The reporter's assessment of the causal relationship of "she was very stressed and was admitted to a hospital", "pneumonia", "bad episode; woke up with an episode", "her ulcers and sinuses are acting up; she has multiple ulcers", "her ulcers and sinuses are acting up", "environmental allergies are acting up", "her ulcers and sinuses are acting up/environmental allergies are acting up", "legs and feet have been having trouble resisting the cold", "could not move around much", "continued to be pretty weak; could not stand for a shower", "had a hard time clipping dog leash and had to use 2 hands because her hands were weak", "pain", "infections in her ears", "infections in her ears and throat", "pulled a muscle in her back" and "potassium was very low" with the suspect product(s) BNT162b2 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.  Comment: A 73-year-old female with periodic paralysis, allergies, ulcers, primary myotonia congenital, quadriplegic prior to starting keveyis, initiated keveyis in spring 2017. She was vaccinated against covid-19 (Pfizer). In Jan2022, allergies, ulcers, and sinuses were "acting up" and legs had trouble resisting the cold. In Feb2022, she had covid (headache) for 7 days. In May2022, she had episodes and continued to be weak but keveyis "knocked it out" in a week and all symptoms resolved. In 2022, she woke with pain and treated with marijuana. She had infections in her ears and throat, congestion, pneumonia, and low potassium for which keveyis was held for a few days, then restarted. She pulled a back muscle, but felt it was not related to keveyis. In Mar2023, "levels" were high, she was stressed and was hospitalized. Low potassium is assessed as related. A causal relationship for hospitalization for an unreported reason is unknown. The remaining events are assessed as unlikely related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. no further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Stress, Pneumonia, Paralysis, Disease recurrence, Ulcer, Sinus disorder, Hypersensitivity, Sensitivity to weather change, Peripheral coldness, Hypokinesia, Asthenia, Muscular weakness, Pain, Ear infection, Pharyngitis, Muscle strain and Blood potassium decreased and BNT162B2.      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. ,Linked Report(s) : US-PFIZER INC-202200821828 same patient, different events;