Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Biopsy, Myocardial infarction, Pathology test, Scan
Clinical narrative: Bell's palsy; heart attack; This is a spontaneous report from a contactable other-HCP (patient herself). A 66-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN5318) via an unspecified route of administration in left arm on 17Feb2021 12:00 as dose 2, single (at the age of 66-years-old) for COVID-19 immunization. Vaccination facility type was reported as clinic. Vaccine was not administered at military facility. Patient medical history included diabetes mellitus from 2002, breast cancer from 07Jan2021 to 07Jan2021, seasonal allergy as grass allergy (sensitive to grass), dust allergy even dust mites she was sensitive to. There were no concomitant medications. It was reported that because of her sensitivity, this was diagnosed before the vaccine, she takes Cetirizine like Loratadine, she confirmed she takes the Cetirizine 1 to 2 times a day. They became more sensitive. It was unknown if it got worse after the vaccine. She had not asked her doctor and thought it was because of her age.  She did not intend to be so crazy. She already did what was needed with the vaccine. Historical Vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 27Jan2021 as dose 1, single for COVID-19 immunization. The patient did not receive any vaccine prior to suspect vaccine within 4 weeks. She was working for 40 years, she did not have any adverse events. On an unspecified date in Jun2021, a retired dental physician, not a medical physician was transferred to Pfizer Drug safety from another department, experienced Bells palsy. The patient was hospitalized for Bells palsy from 30Jun2021 to 01Jul2021. She had to rush to the emergency room at night. It was reported that she never had Bells Palsy or her family. Bells Palsy was diagnosed at the end of Jun2021. It took about a month, and they said she was lucky she was only with it for about 2 weeks. Because she was a dentist, she knows about the seventh facial nerve was affected and that was the reason she had a quicker recovery than normal. She got to the hospital right away. She was recovered right now after checking with the doctor. They will keep an eye on it. She was going to oral surgeon next week to make sure everything was fine. She said she had no history of the breast cancer IDC, and she was still triple negative but the actual tumour they got was IDC. She was diagnosed with IDC Cancer, which she later clarified was Breast Cancer in Jun2021 (as reported). She later stated she had the biopsy end of 2020 and got results back from pathology in Jan2021. Attempted to confirm several times if she was saying IVC or IDC or INC and she was referring to inductal carcinoma. They have none on either side of her family history. The patient underwent lab tests and procedures which included biopsy with result as unknown on 07Jan2021. It does not have anything to do with the vaccine, pathology test breast cancer on an unspecified date in Jan2021. The patient was diagnosed with right breast mastectomy after vaccination. She was having 4 chemo every 3 weeks and was on her third week.  She did not think it was relevant. It was a separate issue because she already had biopsy done end of year 2020. On 07Jan2021, she got the report. It did not have anything to do with the vaccine. It was reported that the breast cancer was diagnosed in Jan2021. They got the report from pathology in Jan2021. This was before the vaccine, when earlier she said she was not sure. She earlier said it was either one week before or two weeks after the first vaccine. The first diagnosis was not correct. They only found it was inductal when they took the tumor out on 29Apr2021. She had a right mastectomy when she found out it was IDC. All reports at first were not diagnosed as that on 05Jan2021. In emergency room they did a lot of tests, IV and everything. X-Rays and then did a scan on her head and brain and another test on brain that was done. On 29Apr2021, the patient experienced heart attack. She was very confused with her dates. She first stated she thought discharge was either 29Jun2021 or 01Jul2021 (reported as 01Jun2021). She said it was too much, all these doctors and legal things they are doing. Later stated after looking at paperwork that she was admitted 30Jun2021 and discharged 01Jul2021, but confirmed it was more than 24 hours. She confirmed when asked medical seriousness that it was disabling and did not provide hospitalization at that time. When she thinks back to events regarding the Bells Palsy, she thought that she was having a mild heart attack or something. The results of the test confirmed it was Bells Palsy and she and her doctor researched it at the same time.  She had a friend in that had the same thing. Patient underwent right breast mastectomy from 29Apr2021 for which she was hospitalized from 29Apr2021 to 01May2021. She had Bells Palsy on an unspecified date in Jun2021 (also reported as 28May2021 or 29May2021). She had to rush to the emergency room at night. Breast Cancer was diagnosed prior to getting vaccine and she had right breast mastectomy after vaccine. The reported seriousness of the events was reported as serious (caused/prolonged hospitalization, disabling/incapacitating). She did not wish to provide any information for her friend, who she stated was a female. She said her own daughter was just talking to her friend daughter and she does not have any more information on her. Separate report completed for her friend. The patient visited in physician office follow-up with primary care after she was released. Three days after, she followed up with doctor. She just went over whatever medications she had or whatever it was that the ER did. She saw to it that she was referred out to Ophthalmology and she was on Medicare and she was gatekeeper. She made her appointments with optometrist, ENT and everybody that she needed to see. When she had it she spoke with her doctor as a follow up and they researched it and found out there were 73 cases of Bells Palsy from the Pfizer COVID vaccine in Jan2021, she thinks or 2020 something. These were adverse effects from Pfizer.  It is not even a final number at this point in time.  She did not have information to report for the 73 people that she read about. She would like to know if there are ongoing cases for Bells Palsy from the Pfizer COVID Vaccine. The outcome of the events was unknown.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Bell's palsy, Myocardial infarction and suspect drug BNT162B2 cannot be completely 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.