Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Facial paralysis, Muscular weakness, Speech disorder
Clinical narrative: facial drooping/I can't drink on that side of my mouth. When I drink water goes out/Bell's palsy; having a stroke on her left side of her face; she was unable to hold a cigarette.; My speech is messed up; This is a spontaneous report from a contactable consumer, the patient.  A 42-years-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 21Jul2021 at 16:00 (at the age of 42-years-old) (Batch/Lot Number: EW0198) as dose 2, single for covid-19 immunization. Medical history included anxiety (Diagnosed about 10 years ago), depression (Diagnosed about 10 years ago), heartburn and back pain: all from an unknown date and ongoing. Concomitant medications included sertraline hydrochloride (ZOLOFT) 200 mg, daily taken for depression, start and stop date were not reported; lorazepam 1 mg three times a day taken for anxiety, start and stop date were not reported; omeprazole 40 mg once a day taken for heartburn, start and stop date were not reported; quetiapine 50 mg once at bedtime taken for an unspecified indication, start and stop date were not reported; ibuprofen (Additional Information for concomitant Products Ibuprofen: The caller didn't take it right before the vaccine or right after the vaccine) 600 mg taken for back pain, start and stop date were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect: None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination)? anxiety, depression. Family Medical History Relevant to AE(s): Dad died of a heart attack at 51 years old. Patient reported that she received the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 28Jun2021 and the second dose on 22Jul2021 (later clarified as 21Jul2021). A day later after the second dose, she was unable to hold a cigarette. She has also been experiencing facial drooping. She has already filled a safety report. "I can't drink on that side of my mouth. When I drink water goes out." She is asking for any information, if this could get worse or is this something permanent. and if anyone has experienced this before. She stated she had already filled a safety report. Referred her to an HCP or doctor. "I already called my doctor, called the Pharmacy and CDC and they are just giving me numbers to call. I don't even know where I am now.". The caller was calling about the second dose of the Pfizer covid vaccine. The caller received her second dose yesterday at 4:00 pm. At 7:30 pm on 22Jul2021 the caller wasn't feeling right on the left side of her face. The caller went outside to smoke and couldn't hold the cigarette in her lips, the cigarette fell out. It looks like the caller is having a stroke on her left side of her face. The caller has severe anxiety and called her regular doctor at 9:00. The caller called (pharmacy) and asked them if this could be a side effect of the vaccine, the woman at (pharmacy) she said no and then she said it can be an adverse effect. Event: The caller tried to hold her cigarette in the right side of the mouth and couldn't hold to there. The caller's left side of her face has droopy look to it. It looks like that side of her lips are on vacation. First Dose: Received 28Jun2021, lot EW0180, NDC and expiration date unknown. Second Dose: Received 21Jul2021, lot EW0198, NDC and expiration date unknown. The caller was prescribed 50 mg of Prednisone after this event. When this event happened, the caller laid down and went to bed and didn't think much of it. When the caller woke up it was still there so she started worrying. Consumer stated, "The reason my speech is messed up is because of your Pfizer shot I took. I have a number on where I called yesterday to make this report because at that time I didn't know what was wrong with me. I may now know what is wrong with me. Can you look it up the report number, can you look up the report number?" When confirmed consumer's first name, consumer stated, "Is there somebody else to speak to? I have been at the hospital all day I am tired, I am frustrated, my face is completely screwed up because of this stupid shot that I didn't know was a side effect or could possibly be a side effect too. I have Bell's palsy, okay it's called Bell's palsy." Concern paraphrased: Consumer stated, "Yes three and a half hours after my second vaccine. I thought I was dying of a stroke (event captured as per verbatim)." Date of administration of second shot: Consumer stated, "The Pfizer shot? I got the shot. I am going to hang up the call and try to get somebody. I mean you can't understand me and I am not been able to understand anything you are saying on the top of it. And this is making it 100 times more difficult than it needs to be. And I am too 'tired' to deal with it, it's annoying, I am mad because of what is happening on my face because of a shot, (voice not clear).". QR Comment: Reporter type could not be probed as the consumer hung up the call, hence captured by default as consumer or other non health professional in tab. Patient also stated "That is why I am calling you, you hear how I sound, Pfizer shot did this to me. So, I had been to an emergency room and found that I have bell's palsy, three hours after I had my second dose, this is what happened. I am paralyzed on the left side of my face and my left side is drooping down and I can barely talk and they don't know how long it is going to be like this. I am 42 years old (not clarified), I never had health problem, nowhere did I 'believe' that this could be a side effect. So, what should I do now?". Vaccination date of second shot: 21Jul2021. Treatment: Consumer stated, "I went to the emergency room yesterday and they put me on some steroids and 'anti-viral' (not clear) medication". Site of vaccine administration: Consumer stated, "It was on my left.". The events resulted in emergency room visit. The events did not result in physician office visit. The patient received treatment for the events. The outcome of the event she was unable to hold a cigarette and My speech is messed up was unknown and rest all was not recovered..  Information about lot/ batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of facial paralysis,stroke 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.