Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Neurological examination, Oral pain, Pain in extremity
Clinical narrative: muscle weakness to the right eye; can feel a slight droop but not visually; muscle weakness right corner of mouth; right side did seem to be decreased (sensation) compared to left; tongue started to swell; mouth pain; muscle weakness; numbness in her right arm; Pain in the jaw, radiating to the right arm; some jaw pain on the right; This is a spontaneous report received from a contactable nurse based on the information received by Pfizer from Allergan (manufacturer control number: AGN261930).  A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, in Mar2021 (reported as two weeks prior to her Botox injections), as single dose, for COVID-19 immunisation; and botulinum toxin type A (BOTOX COSMETIC Injection, lot number: C6548AC4; expiration date: Jul2023), via an unspecified route of administration, from 09Apr2021, for Glabella, frontalis and crow's feet, at dose "for glabella -12U total (3 injection locations), frontalis- 8 units , and crow's feet - 4 units in each side (2 injection sites of 2 units each on both sides)". Medical history included birth control. The patient was not pregnant and was not breastfeeding at the time of vaccination. Concomitant medication included ethinylestradiol, norethisterone (ALYACEN) taken for birth control, from 2011 (reported as 10 years ago) and ongoing. The patient previously took clindamycin and was allergic. The patient received her first dose of BNT162B2 two weeks prior to her Botox injections (Mar2021). On an unspecified date, the patient started having symptoms of muscle weakness, which she can feel but isn't visual, to the right eye and then a few days later in her right corner of her mouth which progressed into some jaw pain on the right. The patient's neuro assessment was her sensation on the side she was having all her symptoms, her right side did seem to be decreased compared to left. It was also reported that the patient received her first ever Botox treatment on 09Apr2021. On 10Apr2021, she experienced numbness in her right arm, pain in the jaw, radiating to the right arm, this was ongoing and progressing. The patient called her PCP went to the emergency room (ER) on an unspecified date because her tongue started to swell. ER did her blood work on an unspecified date (unknown result) and said to monitory the patent. The patient was given ibuprofen every 8 hours for the events "some jaw pain on the right", "pain in the jaw, radiating to the right arm" and "mouth pain". It was reported that the patient has less arm, mouth and jaw pain probably due to ibuprofen. It was also reported that the patient can feel a slight droop but not visually and experienced muscle weakness on an unspecified date. The muscle weakness was minimal during the neuro assessment. The events did not result to hospitalization. The nurse wanted to know if the numbness in right arm; pain in the jaw, radiating to the right arm; and swelling of tongue has been experienced in the past. The patient was recovering from the events "some jaw pain on the right", "numbness in her right arm", "pain in the jaw, radiating to the right arm", and "mouth pain". The outcome of the event "can feel a slight droop but not visually" was unknown, while the outcome of the remaining events was not recovered.  Information about batch/lot number has been requested.; Sender's Comments: Based on the limited information in the case report, a possible causal relationship between events Extraocular muscle paresis, facial paralysis and suspect drug BNT162B2  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.