Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Post procedural haemorrhage, Pyrexia, Urethral haemorrhage, Vaginal haemorrhage
Clinical narrative: Flu-like symptoms; Nausea; Diarrhea; Fever; Pain right leg; Fatigue extreme; Postoperative bleeding/Post hysterectomy urethra; Postoperative bleeding/Post hysterectomy urethra/vaginal bleeding; Postoperative bleeding/Post hysterectomy urethra/vaginal bleeding; This is a solicited report from the marketing program facilitated collect received from a contactable consumer (patient) based on information received by Pfizer, manufacture number 21K-163-4058010-00.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via intramuscular route on 24Aug2021 (at the age of 66-year-old) as dose 1, single, for covid-19 immunisation; and adalimumab (HUMIRA, Solution for injection in pre-filled pen, lot number and expiry date were not reported) subcutaneous from on an unspecified date in 2021 to Jun2021 at an unknown dose and frequency (reported as citrate free) for moderate to severe rheumatoid arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced extreme fatigue. On 24Aug2021, the patient experienced flu-like symptoms, nausea, diarrhea and fever. The reporter considered the events as non-serious. The action taken in response to the events for BNT162B2 was not applicable, while for adalimumab was unknown. The outcome of the events nausea and fever reported as unknown and for all remaining events reported as not recovered.   The reporter's causality for the events of extreme fatigue was not provided; for remaining all events was reported as possible for Covid-19 vaccine and reporter's causality for all events was not provided for suspect Humira.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: causality for the event fatigue was amended.  Follow-up (30Sep2021): New information received by Pfizer (Mfr. Control No.: 21K-163-4058010-00) via the same contactable consumer (patient reported for herself) includes: medical history,  course and seriousness of previously reported events (events extreme fatigue, flu-like symptoms, nausea, diarrhea and fever were now serious), and new adverse events (post procedural bleeding, and post hysterectomy urethra/vaginal bleeding). Case is now serious.  Patient medical history included hysterectomy on an unknown date. On unknown dates in 2021, the patient experienced postoperative bleeding, post hysterectomy urethra/vaginal bleeding and severe fatigue. In Aug2021, the patient experienced pain right leg. On 24Aug2021, the patient experienced flu-like symptoms, nausea, diarrhea and fever. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. The patient stated that she held off humira injections for approximately two months before the vaccine due to insurance problems. and she had fever, flu-like symptoms, nausea, diarrhea starting the day of vaccine shot injection number one. She had severe fatigue and diarrhea incontinent. Still not taking the humira now. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Aug2021. patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 01Sep2021. patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The events were reported as other medically important conditions. Concomitant drugs were not reported. The outcome of the events fatigue extreme, pain right leg, flu-like symptoms, and diarrhea was not recovered; while for the other events reported was unknown.   Opinion was that there was no reasonable possibility that the events of post hysterectomy urethra/vaginal bleeding unknown onset, post hysterectomy urethra/vaginal bleeding unknown onset, severe fatigue, flu-like symptoms, nausea, diarrhea, fever and pain right leg are related to humira (adalimumab).  Causality for Humira (ADALIMUMAB) and the events postoperative bleeding, hysterectomy, fatigue extreme, flu-like symptoms, nausea, diarrhea, fever, and pain right leg as per reporter was not reported while as per manufacturer was that there was no reasonable possibility; while causality per reporter for Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) and the events was postoperative bleeding, hysterectomy, fatigue extreme was not reported, and for the events flu-like symptoms, nausea, diarrhea, and pain right leg was possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events Influenza like illness, fatigue, Nausea, Diarrhea, Pyrexia, pain in extremity, post operative bleeding, urethral bleeding, vaginal bleeding  and the suspect 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.