Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: coughed; some increased spasticity; irritable bowel syndrome; could not eat; having difficulty drinking enough; runny nose; neuropathy symptoms in her hands, feet and legs; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy symptoms in her hands, feet and legs) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TERIFLUNOMIDE (AUBAGIO) coated tablet for Multiple sclerosis.    Concurrent medical conditions included Multiple sclerosis since 2005, Gastrointestinal disorder (stomach and bowel problem), Hypersensitivity and Neuropathy peripheral.   In May 2021, the patient started TERIFLUNOMIDE (AUBAGIO) (unknown route) 14 milligram once a day. On 21-Jun-2021, TERIFLUNOMIDE (AUBAGIO) (Oral) dosage was changed to 7 milligram once a day. On 21-Jul-2021, TERIFLUNOMIDE (AUBAGIO) (Oral) dosage was changed to 14 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy symptoms in her hands, feet and legs) (seriousness criterion medically significant) and RHINORRHOEA (runny nose). On 13-Jul-2021, the patient experienced IRRITABLE BOWEL SYNDROME (irritable bowel syndrome) and DECREASED APPETITE (could not eat). 13-Jul-2021, the patient experienced FLUID INTAKE REDUCED (having difficulty drinking enough). On an unknown date, the patient experienced COUGH (coughed) and MUSCLE SPASTICITY (some increased spasticity). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy symptoms in her hands, feet and legs) and MUSCLE SPASTICITY (some increased spasticity) had not resolved, IRRITABLE BOWEL SYNDROME (irritable bowel syndrome) had resolved and DECREASED APPETITE (could not eat), FLUID INTAKE REDUCED (having difficulty drinking enough), COUGH (coughed) and RHINORRHOEA (runny nose) outcome was unknown.            No concomitant medications were provided by the reporter.  It was reported that on 13-Jul-2021 and 14-Jul-2021, the patient experienced events. The consumer had not called the doctor yet. The nurse mentioned that the consumer had not had diarrhea since then (unspecified). One week after starting on the Aubagio 7 mg dose, she did have some diarrhea. She only had one episode. Patient stated she had her first two COVID Moderna injections with no problems and 4 months after the second Moderna injection, she had experienced events. The patient also had a stomach issue (abdominal discomfort) that possibly caused that as well as she had irritable bowel syndrome. When asked if she had any issues, she stated that she had a runny nose (rhinorrhoea) and it was probably due to allergies.  No treatment medications were provided by the reporter.  The symptoms Hypoaesthesia and Paraesthesia were subsumed under the event Neuropathy peripheral severe stomach cramps and pain / stomach issue and Diarrhea were subsumed under irritable bowel syndrome.  It was reported that the patient had severe diarrhea & was having severe stomach cramps & pain for about a week.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.  Company comment: This spontaneous case concerns a 63-year-old, female patient with medical history of Multiple Sclerosis (since 2005) treated with the co-suspect product Aubagio (teriflunomide) and medical history of Peripheral Neuropathy, who experienced the unexpected, serious (medically significant) event of neuropathy peripheral, the unexpected, non-serious event of irritable bowel syndrome, and other unexpected, non-serious events. Of note, the patient started taking Aubagio 14 mg daily in May2021. On 21Jun2021, the dose was reduced to 7 mg daily and after 1 month, the dose was increased back to 14 mg daily. The event neuropathy peripheral occurred unknown number of days after taking Aubagio and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date was not provided and the event onset date was reported as unspecified date in 2021, hence, the onset latency could not be assessed. The events irritable bowel syndrome, decreased appetite and fluid intake reduced occurred 22 days after taking Aubagio 7 mg and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. The other non-serious events occurred unknown number of days after taking Aubagio and unknown number of days after receiving the second dose of the mRNA-1273 vaccine since the event onset dates were either not reported or reported as unspecified date in 2021, hence, the onset latency could not be assessed. It was reported that the patient initially experienced one episode of diarrhea 1 week after taking Aubagio 7 mg. This was accompanied by abdominal discomfort. After 15 days, the patient experienced severe diarrhea and severe stomach cramps/pain which lasted for about a week. Since the diarrhea, she could not eat and she had difficulty drinking enough fluids. The patient also experienced cough and runny nose (reported as probably due to allergies). It was reported that 4 months after receiving the second dose of the mRNA-1273 vaccine, the patient experienced some muscle spasticity and neuropathy symptoms in her hands, feet and legs with numbness and tingling. The neuropathy symptoms were reported to be more intense than before starting Aubagio. Treatment information for the reported symptoms were not provided. The medical history of Peripheral Neuropathy remains a confounder for the event neuropathy peripheral. The co-suspect product Aubagio remains a confounder for the event irritable bowel syndrome since diarrhea is a common side effect of the medication. Aubagio also remains a confounder for the event neuropathy peripheral which is a serious side effect of the medication. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-624614 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 63-year-old, female patient with medical history of Multiple Sclerosis (since 2005) treated with the co-suspect product Aubagio (teriflunomide) and medical history of Peripheral Neuropathy, who experienced the unexpected, serious (medically significant) event of neuropathy peripheral, the unexpected, non-serious event of irritable bowel syndrome, and other unexpected, non-serious events. Of note, the patient started taking Aubagio 14 mg daily in May2021. On 21Jun2021, the dose was reduced to 7 mg daily and after 1 month, the dose was increased back to 14 mg daily. The event neuropathy peripheral occurred unknown number of days after taking Aubagio and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date was not provided and the event onset date was reported as unspecified date in 2021, hence, the onset latency could not be assessed. The events irritable bowel syndrome, decreased appetite and fluid intake reduced occurred 22 days after taking Aubagio 7 mg and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. The other non-serious events occurred unknown number of days after taking Aubagio and unknown number of days after receiving the second dose of the mRNA-1273 vaccine since the event onset dates were either not reported or reported as unspecified date in 2021, hence, the onset latency could not be assessed. It was reported that the patient initially experienced one episode of diarrhea 1 week after taking Aubagio 7 mg. This was accompanied by abdominal discomfort. After 15 days, the patient experienced severe diarrhea and severe stomach cramps/pain which lasted for about a week. Since the diarrhea, she could not eat and she had difficulty drinking enough fluids. The patient also experienced cough and runny nose (reported as probably due to allergies). It was reported that 4 months after receiving the second dose of the mRNA-1273 vaccine, the patient experienced some muscle spasticity and neuropathy symptoms in her hands, feet and legs with numbness and tingling. The neuropathy symptoms were reported to be more intense than before starting Aubagio. Treatment information for the reported symptoms were not provided. The medical history of Peripheral Neuropathy remains a confounder for the event neuropathy peripheral. The co-suspect product Aubagio remains a confounder for the event irritable bowel syndrome since diarrhea is a common side effect of the medication. Aubagio also remains a confounder for the event neuropathy peripheral which is a serious side effect of the medication. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.