Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Investigation, Nausea, Osteomyelitis, Pain in extremity
Clinical narrative: Bone infection; Blister infected; Stress; Stool discolored; Defecation urgency; Diarrhea aggravated; Abnormal faeces; Worsening of diabetes; Swelling of legs; Pain in toe; Chills; Localised feeling of warmth; Coldness of skin; Fatigue; Headache recurrent; Nausea; Dizziness; This is a solicited report from a non Pfizer-sponsored program (manufacturer control number: 21K-163-4085448-00).   Solicited report by a consumer of a 52 year old female with events of big blister on toe/blister was not getting resolved which turned to an infection and went a down to bone and worsened diabetes and non-serious leg swollen, painful toe, stress, chills, hot to touch, cold to touch, fatigue, recurrent fatigue, recurrent incidence of cold to touch, recurrent incidence of hot to touch, recurrent chills, worsened diarrhea/stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool,headache, nausea, dizziness, recurrent dizziness, recurrent nausea and recurrent headache with pancreatin (CREON). The patient had a relevant medical history of gestational diabetes. The patient has other concomitant therapy of unspecified depression pill. In 2021, the patient experienced big blister on toe/blister was not getting resolved which turned to an infection and went a down to bone. On 18Jun2021, the patient experienced chills, hot to touch, cold to touch, fatigue, headache, nausea and dizziness. On 21Jun2021, the chills, hot to touch, cold to touch, fatigue, headache, nausea and dizziness resolved. On 05Jul2021, the patient experienced recurrent fatigue, recurrent incidence of cold to touch, recurrent incidence of hot to touch, recurrent chills, recurrent dizziness, recurrent nausea and recurrent headache. On 08Jul2021, the recurrent fatigue, recurrent incidence of cold to touch, recurrent incidence of hot to touch, recurrent chills, recurrent dizziness, recurrent nausea and recurrent headache resolved. In Aug2021, the patient experienced big blister on toe/blister was not getting resolved which turned to an infection and went a down to bone, worsened diabetes, leg swollen and painful toe. On 17Sep2021, the patient experienced stress, worsened diarrhea/ stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool and worsened diarrhea/ stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool. In Sep2021, the worsened diarrhea/ stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool resolved. Pfizer BiontechCOVID-19 vaccine (tozinameran) was also considered suspect. The patient stated when she had the COVID-19 vaccine she also had chills, hot to touch that eventually became cold to touch, had fatigue and headache. She had a big blister on her toe and leg was swollen. The toe was extremely painful. A week after, she was rushed to the emergency room since blister was not getting resolved and was hospitalized on 23 Aug2021 while the blister turned to an infection that went all the way down to her bone that was why she needed a foot surgery and stayed there for a week. She was wrapping her foot after wound care as part of her treatment. She was supposed to have unspecified intravenous antibiotic infusions for six weeks but not could not go to the hospital regularly just to take that antibiotic and asked for oral ciprofloxacin antibiotics as an alternative. From time to time she was resting her foot up for faster recovery of her toe. Health care professional had increased the dose of Creon due to worsened diarrhea where stools were oily depending on what she ate and were bright orange. Where when she stood there was an urge to go to the bathroom unexpectedly. She had unspecified depression pill as part of her concomitant medications. She also had unspecified water pill as part of her past medications. In response to the events, therapy with adalimumab (HUMIRA) continued unchanged.   It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  On 18Jun2021, she received the 1st dose of COVID-19 vaccine manufactured by Pfizer, lot number ew0187, expiration date 31Aug2021.  On 03Jul2021, she received the 2nd dose of COVID-19 vaccine manufactured by Pfizer, lot number ew0182.  The patient was treated with hydrogen peroxide.  The patient's past medications include: novolog for diabetes and unspecified water pill  Causality for pancreatin (CREON): The reporter's causality for the event(s) of big blister on toe/blister was not getting resolved which turned to an infection and went a down to bone onset in 2021 and worsened diarrhea/ stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool onset 17Sep2021 was not provided. The reporter's causality for the event(s) of big blister on toe/blister was not getting resolved which turned to an infection and went a down to bone onset in Aug2021, worsened diabetes, leg swollen, painful toe, stress, chills, hot to touch, cold to touch, fatigue, recurrent fatigue, recurrent incidence of cold to touch, recurrent incidence of hot to touch, recurrent chills, worsened diarrhea/ stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool onset 17Sep2021, worsened diarrhea/ stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool onset 17Sep2021, worsened diarrhea/ stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool onset 17Sep2021, headache, nausea, dizziness, recurrent dizziness, recurrent nausea and recurrent headache with creon(pancreatin) was no reasonable possibility. Opinion is that there is no reasonable possibility that the events of big blister on toe/blister was not getting resolved which turned to an infection and went a down to bone onset in 2021, big blister on toe/blister was not getting resolved which turned to an infection and went a down to bone onset in Aug2021,worsened diabetes, leg swollen, painful toe, stress, chills, hot to touch, cold to touch, fatigue, recurrent fatigue, recurrent incidence of cold to touch, recurrent incidence of hot to touch, recurrent chills, worsened diarrhea/ stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool onset 17Sep2021, worsened diarrhea/ stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool onset 17Sep2021, worsened diarrhea/ stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool onset 17Sep2021, worsened diarrhea/ stools oily depending on what ate and were bright orange/ urge to go to the bathroom unexpectedly/smelly stool onset 17Sep2021, headache, nausea, dizziness, recurrent dizziness, Recurrent nausea and recurrent headache are related to creon (pancreatin).   Causality for PFIZER: According to the reporter the causality with the events Bone infection was not reported.  According to the reporter the causality with the events Blister infected, Worsening of diabetes, Swelling of legs, Pain in toe, Stress, Chills (1st episode) was not related.  According to the reporter the causality with the events Localised feeling of warmth and its recurrence, Coldness of skin and its recurrence, Fatigue and its recurrence, Chills (2nd episode), Stool discolored, Defecation urgency, Diarrhea aggravated, Abnormal faeces, Headache and its recurrence, Nausea and its recurrence, and Dizziness and its recurrence was probable.  The reporter's assessment of the causal relationship of the reported event Bone infection with 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.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected; Sender's Comments: Based on dose- event relationship post-vaccination and  immune response the causal role of BNT162B2 vaccine cannot be excluded for the reported events  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) : PFIZER INC-202101324705 Same patient and drug / different dose and similar events