Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Internal haemorrhage, Neuropathy peripheral, Pain
Clinical narrative: paralysis of the face with internal bleeding; internal bleeding; neuropathy; extremely sharp pain there; This is a spontaneous report received from contactable Other HCP (patient) from Pfizer sponsored program. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318; Expiration Date: 31May2021)dose 1, via an unspecified route of administration in left arm on 19Feb2021 (at the age of 68-year-old) as 0.3 ml single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had her first dose of the Pfizer Covid vaccine on 19Feb2021. After the vaccine, she had a neurological reaction and was still dealing with that. She wants to know if she should get the vaccine and if there was a booster. She stated that was a neurological reaction at the post injection site of her face. It was flying from place to place and was an extremely sharp pain there. After 3 weeks, it eventually went away. Her concern was, she did have kind of a little development in her foot area with upper part, neuropathy. She was not sure if she has to do a booster. She was working with people and stated that on her vaccination card, the expiration date was 31May2021. She has only had the one shot and is asking about antigens. She is really scared. She had her first dose administered exactly on 09Feb2021. She did not address this with him and made her own assumptions. She stated that she called when she was not sure about the second dose. She did not get any reasonable kind of answer to her question. She was afraid to go, especially because on the opposing side of her face, she had an accident. Had partial paralysis of the face with internal bleeding, associated with pregnancy. It was kind of one of those things that made her question if she should get a second dose. She clarified that a report was filed with Pfizer, that she was not sure if it was Pfizer but it was this same number that she called now, was given the same route. She had already reported all of the mentioned symptoms with that call. Was not given a reference number but states that it was between the first and second dose. It was 7 days after she received the first dose. Assumes that it was the second week of Feb 021. The second dose was scheduled 10Mar2021. It was between that 3-week period. She stated that it was maybe 19Feb2021, clarified that it was 19Feb2021 and not 09Feb2021 as previously stated. Indication: In the medical field she had to have it. Was dealing with patients all of the time. She thought she does have some kind of lung conditions. She thought she should probably go and do it. What happened was very unusual, she did not have a sore arm, that was totally normal. From the place of injection up to the palm of her hand, the left hand was ok. It was nothing to complain about. It did not happen right away; it was the 4th or 5th day. There was no product complaint to report. The outcome of neuropathy, paralysis of the face with internal bleeding, internal bleeding was reported as not resolved and pain was unknown.; Sender's Comments: Based on the plausible temporal relation, the association between the events of facial paralysis, internal bleeding and neuropathy 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.