Sex: F
Vaccine: COVID19
Symptoms: Intellectual disability, Liver function test normal, Mobility decreased, PO2 normal, Pain
Clinical narrative: white cell count was marginally raised; CRP antigen was raised; Her hands are worse and she can't grip; hands are swollen; neurological thing; tenosynovitis; didn't sleep last night; She is becoming weaker and weaker; sweating and chills and some headaches; bodyache/pain; headache; severe chills; fever; This is a spontaneous report from a contactable physician. A 79-years-old female patient (Reporter's wife) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL8982, expiry date: unknown), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first vaccine on 14Jan2021 and at the same night experienced severe chills, fever, headache, and bodyache. Headache and bodyache has progressively gotten worse and patient was given tylenol and motrin which was starting to get less effective. It has been 6 days since the patient had these events, and reporter would like information specific to headaches and bodyaches lasting this long and how they were managed. It was further reported that the patient is too feeble and weak to talk right now. She is becoming weaker and weaker. She had the vaccine on 14Jan2021. That night she had sweating and chills and some headaches. The next day she had headache and pain all over her body. It got worse. It was a serious headache and serious pain. They talked to people who said it was a normal reaction. On the fourth day she got worse. She is getting weaker. He(reporter) wanted to make sure she did not have active COVID. They went to doctor's office and did COVID test, it was negative. Came back and she still had persistent headache. He took her back to the doctor on Sunday. Her CRP antigen was raised, liver function was normal. temp was normal. PO2 was between 96 and 99 which is normal. Her Creatinine was normal 1.2 or something. Her white cell count was marginally raised. Did PCR COVID test and it was normal. That night she slept well. Increased pain medication, Tylenol and nonsteroidal anti-inflammatory over the counter. That relieves the pain for only an hour or two and it comes back again. He clarified that his wife is taking Tylenol 1000mg and the over the counter nonsteroidal anti-inflammatory is Motrin 400mg every six hours. Today when she got up she said she was no better. She can't get out of the chair. It looks like a neurological thing. Her muscle power has reduced. The pain is severe. Her hands are worse and she can't grip. She has tenosynovitis in both hands so it is difficulty to assess. She had injections four or five weeks ago and it got better, but now she can't make a fist and her hands are swollen. Now the pain is intolerable. She is getting weaker and weaker. She is very lively. She may be seventy some years old, but you wouldn't know it. She didn't sleep last night. He is helping her get up and go to the bathroom. She is hurting and suffering. They were asking if there are any patients or people who had this reaction six of seven days after the vaccine. He is taking her to a neurologist today. Another doctor is coming to see her at their house. The outcome of the events bodyache/pain and headache was not recovered, while for other events was unknown. Therapeutic measures were taken as a result of bodyache/pain, headache.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events pain and headache cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.