Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Ear discomfort, Ear pain, Feeling abnormal, Hypoaesthesia
Clinical narrative: Not feeling well at all/does not feel good at all.; Hand swelling; Face tingling and going numb; Face tingling and going numb; Severe left arm pain shooting down arm; She has stomach or abdominal pains/stomach pain that is attacking that and is burning; It seems like it is attacking that and burning/stomach is burning/abdomen is burning/stomach pain that is attacking that and is burning; It seems like it is attacking that and burning/stomach is burning/abdomen is burning/stomach pain that is attacking that and is burning; Making her feel like she needs to pee; Stuttering is coming back; She is having a lot of same symptoms as the stroke and it is tripping her out; She feels like she may pass out when standing up; She is just so upset; Ringing in ears that became painful and feels like it is blocked at back of neck like a cake; Ringing in ears that became painful/She has ringing in ears and now it just hurts/Her ears are painful/Pain in ear; Ringing in ears that became painful and feels like it is blocked at back of neck like a cake; Nauseous/making her nauseous and she wants to vomit; her head has a fuzzy feeling; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Jan2022 14:05 (Lot number: FK9729) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "TIA stroke", start date: Jan2021 (unspecified if ongoing), notes: TIA stroke number 2; "Polyp removed from endometrium", start date: 2021 (unspecified if ongoing), notes: It came back EIN, which was beginning staging of endometrium cancer.; "Polyp removed from endometrium", start date: Nov2021 (unspecified if ongoing), notes: It came back EIN, which was beginning staging of endometrium cancer.; "full hysterectomy", start date: 20Dec2021 (unspecified if ongoing); "HHT" (unspecified if ongoing), notes: Diagnosed a long time ago.; "Chronic Constipation" (unspecified if ongoing), notes: The constipation has been about 12 years; "Chronic cough" (unspecified if ongoing), notes: chronic cough awaiting testing for the cough has been over 4 years.; "COVID" (unspecified if ongoing), notes: Testing got put off because of her surgery and the COVID. There were no concomitant medications. The following information was reported: MALAISE (medically significant) with onset 19Jan2022, outcome "not recovered", described as "Not feeling well at all/does not feel good at all."; PERIPHERAL SWELLING (medically significant) with onset 19Jan2022, outcome "unknown", described as "Hand swelling"; HYPOAESTHESIA (medically significant), PARAESTHESIA (medically significant) all with onset 19Jan2022, outcome "not recovered" and all described as "Face tingling and going numb"; PAIN IN EXTREMITY (medically significant) with onset 19Jan2022, outcome "not recovered", described as "Severe left arm pain shooting down arm"; ABDOMINAL PAIN UPPER (medically significant) with onset 19Jan2022, outcome "not recovered", described as "She has stomach or abdominal pains/stomach pain that is attacking that and is burning"; DYSPEPSIA (medically significant), ABDOMINAL DISCOMFORT (medically significant) all with onset 19Jan2022, outcome "not recovered" and all described as "It seems like it is attacking that and burning/stomach is burning/abdomen is burning/stomach pain that is attacking that and is burning"; MICTURITION URGENCY (medically significant) with onset 19Jan2022, outcome "not recovered", described as "Making her feel like she needs to pee"; DYSPHEMIA (medically significant) with onset 19Jan2022, outcome "not recovered", described as "Stuttering is coming back"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 19Jan2022, outcome "not recovered", described as "She is having a lot of same symptoms as the stroke and it is tripping her out"; PRESYNCOPE (medically significant) with onset 19Jan2022, outcome "not recovered", described as "She feels like she may pass out when standing up"; DEPRESSED MOOD (medically significant) with onset 19Jan2022, outcome "not recovered", described as "She is just so upset "; TINNITUS (medically significant), EAR DISCOMFORT (medically significant) all with onset 19Jan2022, outcome "not recovered" and all described as "Ringing in ears that became painful and feels like it is blocked at back of neck like a cake"; EAR PAIN (medically significant) with onset 19Jan2022, outcome "not recovered", described as "Ringing in ears that became painful/She has ringing in ears and now it just hurts/Her ears are painful/Pain in ear"; NAUSEA (medically significant) with onset 19Jan2022, outcome "not recovered", described as "Nauseous/making her nauseous and she wants to vomit"; FEELING ABNORMAL (medically significant) with onset 19Jan2022, outcome "not recovered", described as "her head has a fuzzy feeling".  She said that they all started within an hour of the vaccine. The patient reported that she was not feeling well at all. Her hands were swelling, face was tingling and going numb, having severe arm pain, stomach or abdominal pains that seems like it was attacking that and burning. Her stomach and abdomen were burning and making her nauseous and she wants to vomit. She was trying to do her breathing. She had ringing in ears and now it just hurts. Her ears were painful and her head has a fuzzy feeling. Pain in ear felt like she needs an ice pack on it. The arm pain was getting better, but she does not know, because she was not moving. She does not think it was serious, but it could be related to and never finished her sentence. She was sitting still and was just trying to keep moving her jaw. She just had major surgery (full hysterectomy) and they said it would be ok to get it. She does not feel good at all and felt like she has to pee. She had a stroke in Jan2021 and stuttering was coming back. She was having a lot of same symptoms as the stroke and it was tripping her out. She looked into the recording and no one asked if she had a bleeding disorder and she has one.  She was mandated to get it by her job and did not want it. She was trying to be patient and be good about it and noticed a lot of stuff was starting to happen again.  She felts like she may pass out when she stands up so she just needs to keep moving and was not good to sit there. She needed to get glasses to see close up and needed that prior. She has not received any other COVID vaccines except this one. She was just so upset and this was what she was afraid of bringing back her stroke symptoms. This was what was happening and she did not have stuttering that bad. It had gone away and was very random and horrible.  When asked if she takes any other medications, she said no and then said the lady said she could take Tylenol. She called yesterday to the doctor that did her hysterectomy to see if she could get the vaccine because she could not go back without it, and they said yes she could. She has HHT (Hereditary Hemorrhagic Telangiectasia) and where all of blood vessels were breaking and coming to the surface. At first, she stated she got just real nauseous from the shot and thought it would be ok and it just progressively got worse, so she just kept drinking water and trying to stay calm. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. There were no prior vaccinations (within 4 weeks) and no events following prior vaccination. The patient had no family Medical History Relevant to the events and no relevant tests. She stated will not be getting any other doses.; Sender's Comments: Based on the temporal relation, the association between the events of malaise, peripheral swelling, hypoaesthesia, paraesthesia, pain in extremity, abdominal pain upper, dyspepsia, abdominal discomfort, micturition urgency, dysphemia, stroke, presyncope, depressed mood, tinnitus, ear pain, ear discomfort, nauseous and feeling abnormal and the suspect product of BNT162B2 cannot be completely ruled out. 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.