Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lethargy, Muscle strain
Clinical narrative: Injury to her anal sphincter/injured the internal anal sphincter; Constipation; Lethargy; Feeling "mentally out of it"; Straining during a bowel movement; Getting uncomfortable; When she is working around the house she feels like she is going to faint; Extraordinary fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on Apr2021 (Batch/Lot number was not reported) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation.  Medical history included allergic/sensitive to most stool softeners, breast cancer, and received chemotherapy.  The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 intramuscularly administered in the right deltoid on 30Mar2021 10:00 (Lot number: GR8732 or 6R8732 [as reported]; Expiration Date: 31Jul2021) as a single dose for covid-19 immunization and experienced Fatigue aggravated, Blood pressure raised, Anxiety aggravated, Depression aggravated, Nervousness, Condition aggravated, Lower extremities weakness of, Coordination impaired, Vaccination site pain, Musculoskeletal stiffness, Hysteria, Difficulty sleeping, Stress, Energy decreased, Ill feeling, Constipation chronic. After the second dose of BNT162B2 , the patient experienced injury to her anal sphincter/injured the internal anal sphincter (anal injury) (medically significant), constipation, lethargy, feeling "mentally out of it", straining during a bowel movement, getting uncomfortable,  when she is working around the house she feels like she is going to faint, and extraordinary fatigue, all in 2021. Event details: Caller (the patient) stated she received both her doses of the Pfizer BioNTech Covid-19 Vaccine in Apr2021 (the first dose also reported on 30Mar2021). Caller stated that since then she has experienced "terrible constipation".  Caller stated she has always been allergic/sensitive to most stool softeners, so she was  not able to take these to treat her constipation. Caller stated she has been in bed since vaccination in Apr due to constipation and fatigue. Caller reported feeling "mentally out of it." Caller also reported straining during a bowel movement and injuring her anal sphincter. Caller stated she has spoken to about 20 doctors and none of them have any idea what to do about this. Caller states she is a patient who received chemotherapy so it was "difficult to treat her". With the 2nd dose she started having very hard bowel movements, extremely hard and she was very mentally out of it to where she didn't realize what was happening to her and she was pushing and straining when she was having defecation and she injured the internal anal sphincter. Then her problems were doubled because she had to take enough stool softeners to keep it soft to get through the problem and the pain is so bad. As she said she is sensitive to most laxative products and the only one on the market is Colace, she thought docusate sodium, and she can't take that anymore because she is allergic to it. She has also had chemotherapy and since her chemotherapy she has had a lot of problems with taking medications. Her reactions to the COVID vaccine were much more strong than for anyone else of course because she had this strong chemotherapy for her breast cancer and the reactions she has had have doubled or tripled in reactivity. She has went from place to place trying to get help with the constipation and she finally found a gastroenterologist who told her to take yogurt and cut up prunes which she has been doing and it has been working until now. She hasn't had problems until now and she doesn't know if she is reacting to the yogurt or the prunes but she is getting uncomfortable. She feels like she is allergic to something that she is eating. She has been mostly in bed since Apr2021 because she has had extraordinary fatigue and she can hardly do anything and that is of course is making the constipation worse. Now she is having other symptoms too. When she is working around the house she feels like she is going to faint. She has one problem after the other. The outcome of events constipation, lethargy, fatigue was not resolved, and of the rest of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Anal sphincter injury 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.