Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site erythema, Vaccination site pain
Clinical narrative: Large redness at injection site; soreness is improving; left arm did have a knot underneath it; dizzy; Loss of Appetite; feels icky; Weak; Shaky; Feeling like she has flu; tiredness; kept falling asleep; left arm is severe, really red and hurts to the touch and very sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 15:00 (Lot number: ENG208) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Dec2020 (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Back Pain" (unspecified if ongoing). Concomitant medication(s) included: REPATHA SURECLICK taken for blood cholesterol increased (ongoing); DILAUDID taken for back pain (ongoing). Vaccination history included: Shingles vaccine (very minor, she was in the doctors office waiting and she got weak and shaky; states it was probably 4 years before NDC, Lot, Expiration Unknown.), for Immunisation, reaction(s): "Weak", "shaky". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Large redness at injection site"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness is improving"; INFLUENZA LIKE ILLNESS (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Feeling like she has flu"; FATIGUE (non-serious) with onset 29Mar2021, outcome "not recovered", described as "tiredness"; SOMNOLENCE (non-serious) with onset 29Mar2021, outcome "not recovered", described as "kept falling asleep"; PAIN IN EXTREMITY (non-serious) with onset 26Mar2021, outcome "not recovered", described as "left arm is severe, really red and hurts to the touch and very sore"; NODULE (non-serious), outcome "unknown", described as "left arm did have a knot underneath it"; DIZZINESS (non-serious) with onset 29Mar2021, outcome "not recovered", described as "dizzy"; DECREASED APPETITE (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Loss of Appetite"; FEELING ABNORMAL (non-serious) with onset 29Mar2021, outcome "not recovered", described as "feels icky"; ASTHENIA (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Weak"; TREMOR (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Shaky". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient states she had Covid before and she does not know if that makes a difference. The patient was hospitalized but not on a ventilator but was on oxygen for 3 months. States she had Covid in Dec2020 and after she was discharged, she stayed on oxygen. The patient states she was beginning to think she was a long hauler because she really did not feel like she was recovering from Covid as well as she should be. The patient states she still had Covid brain, its mush. The patient was concerned because her symptoms were not that crazy, but it was six days, and her left arm was severe, really red and hurts to the touch and very sore. The patient states that she also started feeling like she had the flu and it was six days and she thought she would be getting better but instead she feels worse. The patient states that she knows that fatigue was normal but she did not know it would be so red and lasting six days and now she was feeling like she got the flu after six days, she did not think it would last that long. The patient was asking was this normal and if it should be lasting this long. The patient states she was wondering why after six days she was not getting better. The patient states her arm was very red and painful and she was on dilaudid for extreme back pain and her arm was still sore and she was concerned. NDC, Lot, Expiration of Dilaudid Unknown. States it was in a pharmacy bottle. The patient was on the Repatha shot that she gives herself twice a month for high cholesterol because she was having trouble with breaking off of cholesterol plaque in her eye. The patient states her left arm did have a knot underneath it but that part of it was getting better. States if her arm had improved it was a very slight improvement, states the pain might had improved a little bit but she does not know. The patient states she has not gotten out of bed because she does not feel good so she does not know. The patient was treatment with Ibuprofen and Dilaudid. Dilaudid had not worked because it was superficial on her skin and really hot. NDC, Lot, Expiration Unknown, states it is a pharmacy bottle. The patient clarifies when she stands up, she feels icky like when you have the flu, so dizzy and crappy. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The event does not lead to emergency room or physician office visit. Prior Vaccinations (within 4 weeks) was none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.