Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Biopsy, Blood test, Colonoscopy, Computerised tomogram
Clinical narrative: Progressive weakness; Severe headaches; Extreme brain fog; Dizziness; Diarrhea; Extreme fatigue; Exacerbation of preexisting Sjogrens syndrome; Exacerbation of preexisting Sjogrens syndrome; Erythromelalgia; This is a spontaneous report from a contactable physician. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular administered in arm on unspecified date in Feb2021 (Batch/Lot number was not reported) (at the age of 69-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing sjogren's syndrome. There were no concomitant medications. The patient experienced progressive weakness (hospitalization, disability) in Mar2021, severe headaches (hospitalization, medically significant) in Mar2021, extreme brain fog (hospitalization, disability) in Mar2021, dizziness (hospitalization, disability) in Mar2021, diarrhea (hospitalization, medically significant) in Mar2021, extreme fatigue (hospitalization, disability) in Mar2021, exacerbation of preexisting sjogrens syndrome (medically significant), and erythromelalgia (disability) in Jul2021. The physician reported that patient received the Pfizer Covid vaccine in the end of Feb2021, and about 14 to 15 days later began to experience, progressive weakness, severe headaches, extreme brain fog, dizziness, and diarrhea, which ended up causing her to be hospitalized. Physician wanted to know if these symptoms have been reported. The physician further stated that patient was not hospitalized to treat the symptoms, she was hospitalized to find a diagnosis. Physician knows that these are common symptoms, what physician would like to know was, have these symptoms been reported to last this long, it was common for these symptoms to last a few days, but it has been more than seven months, and although there was a point when it seemed to improve and reached a plateau, it has not improved. The physician just signed a Medical leave of a absence letter for the patient because, being a teacher, she tried going back, but in the first day, she could not do it. The physician also asked if anyone has reported erythromelalgia. This was something new that just showed up. Furthermore, physician stated that patient was 70 years old, active, teacher and healthy. Stated that it persisted several weeks and got worst. Stated that she was admitted to the hospital twice, had numerous bloodwork, had a colonoscopy and biopsy, had a computerized tomogram (CT) and magnetic resonance imaging (MRI) of her head and consultation with infectious disease and rheumatology. Stated that all symptoms started the first week in Mar. Stated that she was admitted to the hospital for extreme fatigue, weakness and diarrhea. Does not have the dates of hospitalization. Stated that she recovered completely from the colonoscopy and biopsy. Stated that she had Sjogrens syndrome prior to the vaccine. Stated that the exacerbation was in May or Jun2021. Stated that she was prescribed Gabapentin for eryphromelalgia 10 days ago and it does not seem to have worked yet. Stated that she had over-the-counter eyedrops for Sjogrens syndrome exacerbation. Stated that she was started on Gabapentin for eryphromelalgia but it does not seem to have worked. Stated that he does not remember how the vaccine was given. Stated that the bloodwork was over time. Stated that he does not have dates and details for the colonoscopy, biopsy, CT and MRI of her head and bloodwork. Therapeutic measures were taken as a result of exacerbation of preexisting sjogrens syndrome and erythromelalgia. The patient was recovering from diarrhea while outcome of the rest of the events was not yet recovered. Relatedness of events progressive weakness, dizziness, headache, brain fog, diarrhea, extreme fatigue, had a colonoscopy, exacerbation of preexisting Sjogrens syndrome, and eryphromelalgia was related to bnt162b2 while prescription of gabapentin for eryphromelalgia 10 days ago and it does not seem to have worked yet was unrelated.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events asthenia, headache, feeling abnormal, dizziness, diarrhoea, fatigue, Sjogren's syndrome, disease progression, eythromelalgia and suspect drug BNT162B2 cannot be excluded.  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.