Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial pain, Fatigue, Hypersensitivity, Hypoaesthesia oral
Clinical narrative: Fatigued; Her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction; Severe pain/The pain is terrible it is ongoing. Her right forehead temporal all the way down the jaw line to her right ear; Blurry vision; That day they diagnosed four other patients with Bell's Palsy who received Pfizer/right side of her face was flaccid/muscles weren't moving; Lips were numb; Sore arm; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, NDC number and expiry Date was not provided) via an unspecified route of administration, administration, administered in right arm on 26Feb2021(at the age of 75-year-old) at single dose for COVID-19 immunization at the workplace of hospital. The patient medical history and concomitant medications were not reported. Family medical history relevant to adverse event, No, she has a twin sister. They went together for the COVID vaccine on the same day but they are fraternal and not identical. All she remembers was a sore arm for 24hours. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced that day they diagnosed four other patients with bell's palsy who received PFIZER on an unspecified date. Sore arm on 26Feb2021. On 04May2021 the patient experienced lips were numb, right side of her face was flaccid, blurry vision on 06May2021, severe pain on 10May2021. It was reported pharmacist stated she was speaking with a patient that needed to be connected to someone about the side effects she was experiencing. Patient stated she talked to Pfizer a while back and they took her to CDC. Patient talked to PFIZER. Muscles weren't moving the treatment on 06May2021 she went to the ER. She woke up actually on the 04May2021 and she was going to go. She got up at 7 and was going to go to the grocery store. She got dressed and she was going to her brush teeth and everything. She looked in mirror and the right side of her face was flaccid and muscles weren't moving and she said her lips were numb. Right side of her face was flaccid. She stated it was disfiguring initially then said it was disabling. She stated it was a slight improvement. Patient talked to a doctor. She wanted to know if it was one of her medications that could cause this. Doctor said she taken Topamax because she has a very fine essential hand tremor so they wanted to try that in her right hand. He said that if it was that medication they would stop it and in a few days it would go away and it persisted and her eye closed. She had her friend take her there. Two ER doctors saw it and they said it Bell's palsy. She has some other symptoms that have occurred about 2.5 to 3 weeks ago with the right side of your face she had severe pain. The pain was terrible it was ongoing. Her right forehead temporal all the way down the jaw line to her right ear. It was disabling you can't imagine. Why did she got this. The pain was still persisting day and night. Her primary doctor ordered physical therapy she had not started treatment. It was not until 08Jun2021 she guesses they are going to do ultrasound she will get an evaluation with the ultrasound to see if they can reduce the inflammation to all those areas where her face was not moving, the muscle. She thought it was important to add that coffee or any liquids drips out of her mouth and onto her top. She has to bend over the kitchen table she can't chew her food on the right side and the food goes up to the gum line and doesn't go anywhere. History and Investigations: patient stated no she was fine before the Pfizer vaccine. Patient was healthy she would walk visited her friends with the COVID thing she had not been visiting that much just on the phone talking or going grocery store. She was not sick with the cold or flu, nothing. She was not stressed. Patient vision was blurry she went to the eye doctor and in the back of the right eye there was two blisters that was representing an allergic reaction. It was ongoing she can't even look at phone. She has to got the non prescriptive reading glasses. He said she did not need eye glasses. Doctor said to put in eye drops, prescriptive, now they sell it over the counter for allergic reaction to eye. One drop in both eyes. It was persisting she has never had vision problems before all of this. She got both on her right arm because she sleeps on the other side. She should know the number since she used to work there 10 years ago. On 06May2021 she went to the ER and they had two ER doctors verified that it was Bell's Palsy. Just a tid bit the ER doctor said God we never had so many Bell's Palsy patients. That day they diagnosed four other patients with Bell's Palsy who received PFIZER. They did her medication they gave her prednisone 60 mg a day for a week. And the other one was acyclovir an anti-viral 1 gram 3 times a day for a week. The day she got her first injection on 26Feb2021. Then it went away she would say 48hours. The patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199, NDC number and expiry Date was not provided) via an unspecified route of administration, administration, administered in right arm on 19Mar2021 (at the age of 75-year-old) at single dose for COVID-19 immunization at the workplace of hospital. The second vaccine her arm was sore like the first one and she felt fatigued for about 72 hours but then it went away. The CDC had told her on the phone that 10% of people either get neurological or Bell's Palsy from the Pfizer vaccine. The pain was severe and just so unbearable. They were going to do an MRI to see if the virus was still occurring to the 7th cranial never. There was no additional vaccines administered on same date of the PFIZER Suspect. The patient required to visit to the emergency room. The patient did not visit to physician office. The outcome of events her vision is blurry she went to the eye doctor and in the back of the right eye there are two blisters that are representing an allergic reaction, sore arm and fatigued was unknown and rest all events outcome was not recovered.  Information on Lot/Batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Bell's palsy, hypoaesthesia oral, vision blurred, pain, fatigue, pain in extremity, and hypersensi-tivty and the suspect drug.  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.,Linked Report(s) : US-PFIZER INC-2021662119 same reporter/product/event, different patient