Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Gait disturbance, Mastication disorder, Pruritus, Vitreous floaters
Clinical narrative: Eye floaters/ doesn't have eye floaters before but now she does/ now she sees it more and it is pretty much every day; Eye floaters/ doesn't have eye floaters before but now she does/ now she sees it more and it is pretty much every day; did the CRP and it was elevated. C reactive protein- elevated; small bruises; Itching; Difficulty chewing; Joint pain; having difficulty walking; Dry skin; This is a spontaneous report from a contactable physician. A 71-year-old female patient received second dose of bnt162b2 (BNT162B2; batch/Lot Number: EN5318; expiration date not provided), intramuscular on 05Feb2021 as SINGLE DOSE for COVID-19 immunisation. Patient's medical history included ongoing 'Diabetes/High sugar/ Diabetes', lymphoma (reported as in remission now) from 2010 and ongoing, 'General wellbeing' from an unspecified date and unknown if ongoing; eye floaters from an unspecified date and ongoing. Concomitant medications included glipizide from Jan2021 and ongoing for 'High sugar'; metformin from an unspecified date (taking for a long time) and ongoing for 'High sugar/ Diabetes', colecalciferol (VITAMIN D [COLECALCIFEROL]) from an unspecified date (taking for a long time) and ongoing; calcium from an unspecified date (taking for a long time) and ongoing; and cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) from an unspecified date (taking for a long time) and ongoing for 'General wellbeing'. Patient previously took bnt162b2 (BNT162B2; batch/Lot Number: EL1283; expiration date not provided) on 17Jan2021 for COVID-19 immunisation. The patient experienced joint pain and 'having difficulty walking' (both serious, disabling) and dry skin (medically significant) on 19Feb2021; itching, difficulty chewing, and small bruises (all serious, medically significant) on Mar2021; eye floaters on an unspecified date; and 'did the CRP and it was elevated/C reactive protein- elevated' (non-serious) on 08Mar2021. Patient's clinical course is as follows: a physician reporting on behalf of his wife (patient). It was reported that patient received both doses of the COVID-19 vaccine. Reporter stated that they have side effects to report and wanted to find out how common these side effects are and how long they are going to last. Patient received first dose on 17Jan2021 and second on 05Feb2021. It was reported that the patient has been having joint pain starting from 19Feb2021 and it fluctuates from one joint to another so if the patient's shoulder is affected, the joint pain goes to the other side and then to a different joint such as her knee joint. The pain was continuous, and it doesn't disappear. Reporter mentioned that it gets better with medication but it's still not going away. Regarding patient's treatment, it was reported that in the beginning, patient was taking ibuprofen but now the doctor switched it to naproxen (ALEVE) and also added hydrocodone bitartrate and acetaminophen (NORCO). Reporter mentioned that sometimes not only the patient's joints gets affected, patient also experienced difficulty chewing, but it goes away and then comes back. Patient also had dry skin, itching, and sees eye floaters sometimes. Initially, reporter mentioned that patient doesn't have eye floaters before but now she does, then clarified she has seen it before the vaccine, but now she sees it more and it is pretty much every day. Patient also had small bruises. Reporter just wanted to know if someone can tell him if it's related to vaccine and how long this might last. Seriousness criteria for joint was reported that this is disabling as the patient was having difficulty walking, getting up from the bed from the chair, patient has to use a walker to walk and needs help going to bathroom and taking a shower. It was reported that joint pain has definitely affected patient's normal walking. Reporter also mentioned that he was not exactly sure when the dry skin started but it was around the time the joint pain started. Seriousness criteria for dry skin and itching was reported as medically significant because it does bother the patient. Patient was scratching even in her sleep, even though they use the moisturizer and cream. Reporter clarified it was not debilitating but it does bother the patient. Reporter mentioned that difficulty chewing started over the last few days, on Friday or Saturday. It comes and goes, one day patient might have it in the afternoon, but it goes away in the evening. Reporter added that the eye floaters started more in the last one week. They do not know why this is happening, if it was vaccine related or not. The medicines the patient takes shouldn't be causing these, but they don't know if it was the medicine causing it or if it's the vaccine. Causality for was reported as 'didn't have these issues before, thinks it's related, this is for all the events'. It was further reported that the doctor did the CRP and it was elevated also reported as C reactive protein- elevated on Monday 08Mar2021. Outcome of the events 'small bruises' and 'did the CRP and it was elevated. C reactive protein- elevated' was unknown; outcome of the remaining events was not recovered.; Sender's Comments: Based on temporal association and known drug profile, a contributory role of bnt162b2 to the reported events  cannot  be totally excluded.  Case will be reassessed if additional information is received.   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.