Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Burning sensation, Paraesthesia, Thrombosis
Clinical narrative: potentially has blood clot; stomach pain; severe abdominal pain/like severe menstrual cramping abdominal pain/it's more like achy cramping; tingling; burning on the collar bone area; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 04Aug2021 at 19:15 (Batch/Lot Number: EW0168) (at the age of 50-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history was reported as none. There were no concomitant medications. She received her first dose on 04Aug2021 at 7:15pm and during the 30-minute wait time, the patient experienced some tingling and burning on the collar bone area and then it subsided. Then at 04Aug2021 at 23:00, she had severe abdominal pain, it is still there today but has improved some. It felt like severe menstrual cramping abdominal pain, like somebody was stabbing her with knives in the stomach. She stated that it lasted about 45 minutes to an hour, the severity of that, then throughout the whole night off and on she was waking up and it was cramping on and off.  The morning she woke up, the cramping is not as severe, it's still there, it's more like achy cramping. When she called her doctor, they said to just take some Tylenol and if it gets worse go seek urgent care. She did just have her menstrual cycle.  She is concerned about her stomach pain (started on 05Aug2021, as reported) because on the Johnson and Johnson vaccine website, stomach pain is listed as a potential sign of a blood clot. Patient was asking if Pfizer have any information available like this. She has little kids at home and is worried about not going to the ER if she potentially has a blood clot. She reports her main concern is when she started having symptoms, she started looking online, and the abdominal pain is not a common symptom after getting the Pfizer vaccine so after reading about it, it sounds like it could be an adverse reaction. She reports with the J&J, that could mean blood clotting issues so she just needed to know if she needed to go to the emergency room. She reports she did call her family physician and he wasn't very helpful. Outcome of tingling and burning on the collar bone area was recovered on 04Aug2021, abdominal pain was recovering, while rest of events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The association between the event "potential blood clot" with BNT162b2 can not be fully excluded based on the close temporal relationship.  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.