Sex: M
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: COVID-19, Chills, Diarrhoea, Gastrointestinal fistula, Mobility decreased
Clinical narrative: This is a Solicited report based on the information received by Pfizer. This is a non-interventional study report from the marketing program marketing program received from a contactable consumer or other non health care professional. A 39-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via intramuscular route of administration on 2021 as dose 1, single for covid immunisation. Second dose bnt162b2 (BNT162B2,Solution for injection, Batch/Lot number was not reported)via intramuscular route of administration on 2021 as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA) via subcutaneous (Batch/Lot number was not reported) on an unspecified date, at unspecified dose, subcutaneous from 2021 (Batch/Lot number was not reported) to an unspecified date, at UNK, weekly for crohn's disease; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; cannabis sativa (CANNABIS SATIVA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and patient's concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date in 2021, the patient experienced diarrhea that irritated fistula and caused it to get bad, not gaining weight like patient would like and not losing weight like patient was. In 2021, the patient experienced could not get out of bed after Covid vaccine, chills/shivered self to sleep, vomiting, shakes and diarrhea that irritated fistula and caused it to get bad. In Jan2021, the patient experienced Covid. In 2021, he could not get out of bed after Covid vaccine, chills/shivered self to sleep, vomiting, shakes and Covid resolved. Pfizer Biontech Covid-19 Vaccine (tozinameran), Tylenol (paracetamol) and Marijuana (cannabis sativa) were also considered suspect. In Jan2021, the patient had covid. The physician postponed his fistula surgery because his physician was going on vacation and in the meantime, after first Pfizer shot, he could not get out of bed. This lasted only a day. He took second covid shot a couple of weeks later. After second shot he took Tylenol. He started feeling ok, later in the day, got shakes and chills. He went out to his car and took a hit off his Marijuana and some Tylenol at lunch. Then on the way home he started vomiting. He had shivered himself to sleep that day and then the next day he was fine but then the next day he had diarrhea and that irritated his fistula and caused it to get bad. Finally, in mid May2021, he had fistula surgery. He was recovering from fistula surgery. The causality as per reporter for fistula surgery was reported as reasonable possibility. In 2021, he switched to weekly injections. He reported that so far, he was not gaining weight like he would like but not losing it like he was either. Therapeutic measures were taken as a result of gastrointestinal fistula. The patient underwent lab tests and procedures which included weight: not gaining weight on unspecified date. The outcome of the gastrointestinal fistula, weight gain poor, weight loss poor was recovering, the outcome of the events mobility decreased, chills, vomiting, tremor, diarrhoea, covid-19 was recovered. The reporter's causality for the events of diarrhea that irritated fistula and caused it to get bad unknown onset, could not get out of bed after Covid vaccine, not gaining weight like patient would like, not losing weight like patient was and diarrhea that irritated fistula and caused it to get bad onset in 2021 with Humira (Adalimumab) was a reasonable possibility and for the events of chills/shivered self to sleep, vomiting, shakes and Covid with Humira(Adalimumab) was no reasonable possibility. The reporter's causality for all the events with Pfizer Biontech Covid-19 Vaccine (Tozinameran) was not reported. The reporter's causality for all the events with TYLENOL (PARACETAMOL) was not reported. The reporter's causality for all the events with Marijuana (Cannabis Sativa) was Not Reported. The reporter's assessment of causal relationship of event with suspect product was not provided at time of this report. Since no determination has been received, case is managed based on company causality assessment.; Sender's Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on available information a contributory role of BNT162B2 to the reported Gastrointestinal fistula, Mobility decreased, Weight gain poor, Weight loss poor, Chills, Vomiting, Tremors, Diarrhoea and Covid-19 cannot be totally excluded. Additional information including vaccine administration dates, event onset date, concurrent medical conditions, medical history, diagnostic test results, treatment done, is needed to better assess this report. The case will be reassessed further upon receipt of additional information. 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.