Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Right arm injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female unknown pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0179), via intramuscularly in arm right on 08Apr2021 at 12:45 (at the age of 58-year-old) as a dose 1, single for COVID-19 immunisation. The family medical history was reported as none. The patient's medical history included ongoing multiple sclerosis from 08Jan2021, mild aortic atherosclerosis on an unspecified date in Jan2021 and all seasonal allergies, diagnosed 2 years ago, shoulder surgery, diagnosed 3 prednisone shot as far back as 15 years ago with shoulder surgery, allergies to wheat, diagnosed allergies to wheat diagnosed 6 years ago. Past drug event included all steroids, even eyedrops, the patient was also allergic to a lot of medication, allergic to Tetracycline and sulfa drugs for drug allergy. Stated that, she does not have any manufacturers, lots or expirations. The patient's concomitant medications included acetylsalicyclic acid (ASPIRINE), 81 mg, 1x/day on an unspecified date in Jan2021 for cardiac prevention. Prior vaccinations (within 4 weeks) was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Stated that, she does not know the names of other. There was a topical one and Oasis eye drops. The big one with nasal spray. It put her in the hospital to the emergency room and not admitted. It was reported that, call received from the patient regarding the Pfizer COVID vaccine. She wanted to see whether there was anything saying people with autoimmune should not get. Stated that, the first one was fine, just a little soreness that went away. Yesterday ok, little more sore. Right arm injection site soreness was on 08Aapr2021 at 13:00, she sat there for a half hour to make sure she was going to be ok. She has mild aortic atherosclerosis diagnosed on an unspecified date in Jan2021, prior to getting vaccination. She wanted to know whether there was anything else she needed to do. There was no data. She would like to know whether there are any recommendations for what she should do for symptoms and whether she should get checked for COVID. The description of the product complaint included that, the patient received first and second doses of Pfizer COVID vaccine and had some symptoms afterwards. She called hospital hotline to see what she needed to do. She wanted to know if this could be COVID and does she need to be tested. They told her if she still has symptoms on Sunday, she should get checked. They also advised her to let her PCP know. Product strength and count size dispensed was unknown. Additional lot numbers included the second dose of the Pfizer COVID vaccine was given 29Apr2021 with Lot EW0150 and unknown expiration. She also saw the date of 13Apr2021 on the card and did not know what that was. She confirmed date of first vaccine was on 08Apr2021. Was a sample of the product available to be returned was reported as no. Packaging sealed and intact was not provided. The reporter seriousness for the event was considered as worsened. No emergency room or physician's office required. The investigation assessment was reported as no. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.