Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anxiety, Diarrhoea, Haematochezia, Pain in extremity
Clinical narrative: had never had diarrhea in her 39 years of life; was a little achy in her arm; States she was still eating and drinking and feeling fine and had stomach pains and that was the only thing coming out of her body; Anxiety; had gelatinous clear and bloody stools every single day for about 5-6 days; This is a spontaneous report from a contactable other hcp (patient). A 39-years-old female patient received BNT162B2 (Pfizer COVID19 vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 08:00 (age at vaccination 39-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pneumonia and stated she had pneumonia twice in 3 years / had pneumonia but did not receive the pneumonia shot then and in 2017 she had pneumonia so bad that she was in the hospital for two weeks and when she recovered at 100 percent the HCP recommended, she got the pneumonia vaccine, so she got the pneumonia vaccine at that point in 2017 or 2018 and has no lots, expiry dates or name of the vaccine to provide. No concomitant medications were reported. Relevant Tests, Prior Vaccinations and family Medical History Relevant to adverse event was reported as none. It was reported that after the first dose on that Tuesday morning she had a little anxiety with the vaccine so she did it at 8:00am and by Tuesday night she was a little achy in her arm and she had that before with other vaccines she had in order to prevent the flu or pneumonia but it was not a big deal and by Thursday morning on 05Aug2021 she knew this sounds disgusting but she had gelatinous clear and bloody stools every single day for about 5-6 days (medically significant) after that and called her primary doctor and they stated that it was highly unlikely and was not due to the Pfizer COVID19 vaccine but she was a crazy person and had never had diarrhoea in her 39 years of life and she assumed it was the way she reacted to the vaccine. It was reported that she was still eating and drinking and feeling fine and had stomach pains on an unspecified date and that was the only thing coming out of her body. She stated her HCP told her she needed to wait another day or two and if it persisted to see a GI specialist and she was getting better and this resolved by the 9th or 10th day. At the time of this report, the outcome of events had gelatinous clear and bloody stools every single day for about 5-6 days and States she was still eating and drinking and feeling fine and had stomach pains and that was the only thing coming out of her body was recovered on an unknown date in 2021 while the outcome for other events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events haematochezia and diarrhoea  the suspect drug BNT162B2. 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.